3D Systems Announces FDA 510(k) Clearance Expanding VSP Orthopedics Indications to Include Skeletally Mature Adolescents

Rhea-AI Summary

3D Systems (NYSE: DDD) announced FDA 510(k) clearance expanding VSP Orthopedics indications to include skeletally mature adolescents (in addition to adults) effective Dec 15, 2025.

Key effects: removes case-by-case compassionate-use and hospital IRB steps for adolescent patients, targets >1,200 annual U.S. pediatric bone sarcoma cases plus an additional 2,600 primary bone cancer cases in ages 20–39, and brings thousands of complex adolescent reconstructive procedures into scope. The clearance leverages existing DRG/CPT reimbursement, supports double-digit Healthcare segment growth, and builds on >400,000 patient-matched cases delivered to date.

Positive

• Eliminates compassionate-use and IRB steps for adolescents
• Addresses >1,200 annual U.S. adolescent bone sarcoma cases
• Adds 2,600 primary bone cancer cases (ages 20–39) in scope
• Procedures covered under existing DRG/CPT reimbursement
• Supports double-digit average annual Healthcare segment growth
• Over 400,000 patient-matched cases/devices delivered to date

Negative

• None.

News Market Reaction

+2.63%

5 alerts

+2.63% News Effect

+2.5% Peak in 25 hr 34 min

+$7M Valuation Impact

$263M Market Cap

0.6x Rel. Volume

On the day this news was published, DDD gained 2.63%, reflecting a moderate positive market reaction. Argus tracked a peak move of +2.5% during that session. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $7M to the company's valuation, bringing the market cap to $263M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Annual osteosarcoma/Ewing cases: Over 1,200 cases Young adult bone cancer cases: 2,600 cases Patient-matched cases delivered: Over 400,000 cases/devices +5 more

8 metrics

Annual osteosarcoma/Ewing cases Over 1,200 cases U.S. patients under 20 per year

Young adult bone cancer cases 2,600 cases Primary bone cancers in ages 20–39, annually

Patient-matched cases delivered Over 400,000 cases/devices Total VSP patient-specific cases across indications

Share price $1.90 Prior close before FDA clearance news

Price vs 52-week high -61.99% Distance from 52-week high of $4.9991

52-week low $1.32 52-week trading range low

Trading volume 3,309,079 shares Today vs 20-day average of 2,938,522

Market capitalization $253,613,888 Equity value prior to this announcement

Market Reality Check

Price: $2.24 Vol: Volume 3,309,079 is 13% a...

normal vol

$2.24 Last Close

Volume Volume 3,309,079 is 13% above the 20-day average of 2,938,522 ahead of this news. normal

Technical Shares at $1.90 are trading below the 200-day MA of $2.19 and 61.99% under the 52-week high.

Peers on Argus

DDD fell 3.55% while key peers like NNDM (-1.12%), OSS (-1.94%), UMAC (-6.36%), ...

DDD fell 3.55% while key peers like NNDM (-1.12%), OSS (-1.94%), UMAC (-6.36%), QMCO (-7.38%), and CAN (-6.61%) also traded lower, but no peers appeared in momentum scans and no same-day peer news is recorded.

Historical Context

5 past events · Latest: Dec 09 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Debt equitization	Negative	-16.9%	Exchange of 0% 2026 convertible notes into common shares.
Nov 11	Product launch	Positive	+4.5%	Launch of next-generation stereolithography systems and materials.
Nov 04	Earnings report	Negative	-5.1%	Q3 2025 revenue decline and weaker gross margin disclosed.
Oct 30	Earnings scheduling	Neutral	-6.9%	Announcement of date and logistics for Q3 2025 results.
Oct 27	JV milestones	Positive	-1.9%	Saudi JV NAMI securing industrial and defense manufacturing deals.

Pattern Detected

Across recent events, DDD’s shares often declined on both negative and neutral/positive news, with 3 of 5 items showing price moves aligned with the apparent news tone and 2 showing divergence.

Recent Company History

Over the last few months, 3D Systems has focused on balance sheet repair, product innovation, and geographic expansion. On Oct 27, it announced Saudi growth milestones, then on Nov 4 reported Q3 2025 results with revenue of $91.2 million and margin pressure. New stereolithography solutions were unveiled on Nov 11. On Dec 9, a $30.773 million convertible note equitization deal was disclosed. Today’s FDA clearance for expanded VSP Orthopedics indications fits the broader pivot toward higher-margin healthcare solutions.

Market Pulse Summary

This announcement highlights FDA 510(k) clearance expanding VSP Orthopedics indications to skeletall...

Analysis

This announcement highlights FDA 510(k) clearance expanding VSP Orthopedics indications to skeletally mature adolescents, directly targeting over 1,200 annual osteosarcoma/Ewing sarcoma cases under 20 and 2,600 young adult bone cancer cases. The platform builds on over 400,000 patient-matched cases and ties into 3D Systems’ strategy around high-margin Med Tech services. Recent history also includes debt equitization and weaker Q3 revenue, so investors may monitor how new adolescent volumes, reimbursement under existing DRG/CPT codes, and segment growth affect overall margins and cash flow.

Key Terms

510(k) clearance, virtual surgical planning, patient-specific instrumentation, osteosarcoma, +4 more

8 terms

510(k) clearance regulatory

"the U.S. Food and Drug Administration has granted 510(k) clearance expanding"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

virtual surgical planning medical

"VSP® Orthopedics virtual surgical planning and patient-specific instrumentation platform"

Virtual surgical planning uses medical scans and 3D computer models to map and rehearse an operation before it happens, much like a pilot using a flight simulator. It matters to investors because it can reduce surgery time, lower complication rates, and create demand for specialized software, imaging services and custom surgical tools, which can change costs, reimbursement and revenue prospects across healthcare companies.

patient-specific instrumentation medical

"virtual surgical planning and patient-specific instrumentation platform to include"

Surgical tools or guides custom-made from a patient’s medical scans to match that person’s unique anatomy, often produced with 3D printing; think of them as tailor-made templates that help a surgeon cut, drill or place implants in the exact right spot. They matter to investors because they can make operations quicker and more accurate, lower complication and revision rates, and shift procedure costs and device demand—factors that affect hospital purchasing, reimbursement and medical-device company revenues.

osteosarcoma medical

"Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients"

A rare but aggressive form of bone cancer that usually starts in cells that build bone, most often affecting the long bones of the arms and legs. For investors, it matters because the disease’s severity, patient numbers, and difficulty of treatment shape the market for drugs and medical devices, influence clinical trial design and regulatory reviews, and can drive the potential value or risk of companies developing new therapies—think of it as a small but high-stakes market niche.

Ewing sarcoma medical

"Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients"

Ewing sarcoma is a rare, aggressive cancer that most often starts in bone or the soft tissue around bones, typically affecting children and young adults. It matters to investors because treatments, clinical trial results, and regulatory decisions for this disease can create significant commercial and financial impact: think of it like a small, high-stakes niche market where a successful new therapy can quickly change a company’s revenue prospects, valuation, and risk profile.

osteotomies medical

"Thousands of complex lower-limb osteotomies and reconstructive procedures annually"

A surgical procedure that cuts and repositions bone to correct alignment, relieve pain, or change limb length—think of reshaping a bent frame so it bears weight properly. It matters to investors because osteotomies drive demand for specific implants, surgical tools, and rehabilitation services, influence procedure volumes and reimbursement, and can affect clinical trial needs and regulatory approvals in orthopedics and related medical-device markets.

additive manufacturing technical

"surgical guides produced on 3D Systems’ additive manufacturing platforms"

Additive manufacturing, often called 3D printing, builds physical parts by laying down material layer by layer from a digital design, rather than cutting or molding from a solid block. It matters to investors because it can cut production time and waste, enable cheaper prototypes and customized products, and reshape supply chains—changes that can lower costs, speed new products to market, and create competitive advantages that affect a company's revenue and margins.

DRG/CPT codes regulatory

"Procedures covered under existing DRG/CPT codes for tumor resection"

DRG (Diagnosis-Related Group) and CPT (Current Procedural Terminology) codes are standardized labels used by hospitals and doctors to describe a patient’s diagnosis and the treatments or procedures performed. Think of them as the universal product barcodes and receipts for medical services: they determine how insurers pay providers and reveal what care was given. For investors, these codes signal revenue mix, reimbursement levels, and utilization trends that affect healthcare companies’ earnings and cash flow.

AI-generated analysis. Not financial advice.

Removes Key Adoption Barriers in Pediatric/Adolescent Oncology and Deformity Market

ROCK HILL, S.C., Dec. 15, 2025 (GLOBE NEWSWIRE) -- 3D Systems (NYSE: DDD) today announced that the U.S. Food and Drug Administration has granted 510(k) clearance expanding the indications for its VSP^® Orthopedics virtual surgical planning and patient-specific instrumentation platform to include skeletally mature adolescents of normal bone stature, in addition to adults.

Key Investment Highlights

• Immediate commercial acceleration: Eliminates case-by-case compassionate-use approvals and hospital IRB reviews previously required for these adolescent patients, streamlining workflows and converting off-label usage into standard, reimbursable procedures at leading centers.
• Targets high-acuity, underserved segment:
  • Over 1,200 new annual U.S. cases of osteosarcoma and Ewing sarcoma in patients under 20 (American Cancer Society, SEER estimates).
  • Additional 2,600 primary bone cancer cases in young adults (20–39) now fully in-scope.
  • Thousands of complex lower-limb osteotomies and reconstructive procedures annually for congenital, developmental, and trauma-related deformities in adolescents.
• Strong, Sustainable Financial Model: VSP Orthopedics cases generate service fees for virtual planning combined with revenue from patient-specific 3D-printed anatomic models and single-use surgical guides produced on 3D Systems’ additive manufacturing platforms. Resulting revenues contribute to the strong, double-digit annual growth rates and highly accretive gross margins associated with 3D Systems’ Med Tech business.
• Strengthened competitive moat: 3D Systems is the only provider with FDA-cleared VSP solutions spanning craniomaxillofacial, orthopedics, and now expanded adolescent applications, with a total of over 400,000 total patient-matched cases and devices delivered to date.
• Favorable reimbursement: Procedures covered under existing DRG/CPT codes for tumor resection, osteotomy, and reconstruction—no changes required.
  
  

Ben Johnson, senior vice president of medical technology at 3D Systems commented, “This regulatory clearance removes a significant friction point for adoption in the pediatric/adolescent orthopedic oncology segment. Surgeons at leading centers have been using off-label or compassionate use solutions for years; this decision immediately converts those cases into routine clinical practice and opens the U.S. adolescent bone sarcoma and deformity market to our platform. We are thrilled to now offer these solutions to an expanded and underserved patient population.”

This regulatory clearance further supports 3D Systems’ focus on high-margin personalized healthcare solutions amid ongoing segment optimization efforts. Continuing expanded indications provides a meaningful tailwind for sustaining double-digit average annual growth in the Healthcare segment, driven in part by accelerated adoption in this discrete, high-value market.

About 3D Systems

For nearly 40 years, Chuck Hull’s curiosity and desire to improve the way products were designed and manufactured gave birth to 3D printing, 3D Systems, and the additive manufacturing industry. Since then, that same spark continues to ignite the 3D Systems team as we work side-by-side with our customers to change the way industries innovate. As a full-service solutions partner, we deliver industry-leading 3D printing technologies, materials and software to high-value markets such as medical and dental; aerospace, space and defense; transportation and motorsports; AI infrastructure; and durable goods. Each application-specific solution is powered by the expertise and passion of our employees who endeavor to achieve our shared goal of Transforming Manufacturing for a Better Future.  

Forward-Looking Statements

Certain statements made in this release that are not statements of historical or current facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "believes," "belief," "expects," "may," "will," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management’s beliefs, assumptions, and current expectations and may include comments as to the company’s beliefs and expectations as to future events and trends affecting its business and are necessarily subject to uncertainties, many of which are outside the control of the company. The factors described under the headings "Forward-Looking Statements" and "Risk Factors" in the company’s periodic filings with the Securities and Exchange Commission, as well as other factors, could cause actual results to differ materially from those reflected or predicted in forward-looking statements. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not, and should not be relied upon as a guarantee of future performance or results, nor will they necessarily prove to be accurate indications of the times at which such performance or results will be achieved. The forward-looking statements included are made only as of the date of the statement. 3D Systems undertakes no obligation to update or review any forward-looking statements made by management or on its behalf, whether as a result of future developments, subsequent events or circumstances or otherwise.

Investor Contact: investor.relations@3dsystems.com
Media Contact: press@3dsystems.com

FAQ

What did 3D Systems (DDD) announce on Dec 15, 2025 regarding VSP Orthopedics?

The company announced FDA 510(k) clearance expanding VSP Orthopedics indications to include skeletally mature adolescents in addition to adults.

How many new adolescent cases does the DDD FDA clearance target annually?

The clearance targets over 1,200 annual U.S. adolescent bone sarcoma cases plus an additional 2,600 primary bone cancer cases in ages 20–39.

Will 3D Systems (DDD) need new reimbursement codes after the VSP adolescent clearance?

No; the announcement states procedures remain covered under existing DRG/CPT codes for tumor resection, osteotomy, and reconstruction.

How does the clearance affect clinical workflow for adolescent patients using VSP (DDD)?

It removes prior case-by-case compassionate-use approvals and hospital IRB reviews, streamlining workflows and converting off-label use into routine practice.

What financial impact does the DDD clearance claim for the Healthcare segment?

The company says the expansion supports sustained double-digit average annual growth in the Healthcare segment and contributes accretive gross margins.

How extensive is 3D Systems' (DDD) existing VSP footprint?

The company reports over 400,000 total patient-matched cases and devices delivered to date across VSP solutions.