510(k) · Cleared
Cleared3DMetal Tibial Cones
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 18, 2017 as substantially equivalent to K102896 (Zimmer Trabecular Metal Technology, 2010) and 1 other predicate after a 213-day review. Its family tree reaches back 5 generations to 1998.
- Decided
- Aug 18, 2017
- Review
- 213 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K982302 (1998). 15 ancestors in all, the oldest K915132 (1992). No later device cites it as a predicate yet.
- Root · 5 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 4 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 3 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 2 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- 1 generation backK072336 Regenerex Porous Titanium Sleeve AugmentsBiomet Manufacturing Corp · 2007
- This deviceK170149 3DMetal Tibial ConesMedacta International S.A. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −4 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −3 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −2 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| −1 | K072336 | Regenerex Porous Titanium Sleeve Augments | Biomet Manufacturing Corp | 2007 | — |
| 0 (this device) | K170149 | 3DMetal Tibial Cones | Medacta International S.A. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102896 | Trabecular Metal Tibial Cone AugmentsSummary page 4…ification 2 III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: x Trabecular Metal Tibial Cone Augments, K102896, Zimmer Trabecular Metal Technology x Regenerex Porous Titanium Sleeve Augments, K072336, Biomet Manufacturing Corp.… | 2010 |
| * | K072336 | Regenerex Porous Titanium Sleeve AugmentsSummary page 4…es: Primary Predicate: x Trabecular Metal Tibial Cone Augments, K102896, Zimmer Trabecular Metal Technology x Regenerex Porous Titanium Sleeve Augments, K072336, Biomet Manufacturing Corp. Reference Predicate x GMK Total Knee System (also referred to as GMK Primary), K090988, Medacta… | 2007 |
| † | K090988 | GMK Total Knee System | 2009 |
| † | K102437 | GMK Revision Knee System | 2010 |
| † | K130299 | GMK Hinge | 2013 |
| † | K141395 | Delta TT Acetabular System | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 15 ancestors have a recall of any class.
- 6 other devices also cite its predicate K102896.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The 3DMetal Tibial Cones are indicated for use with the GMK Revision and GMK Hinge knee systems, as well as the GMK tibial extension stems and offsets.
Specific indications are as follows:
• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.
• Post traumatic loss of joint configuration.
• Considerable loss of function of the knee joint.
• High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
• Primary implantation failure.
• Former revision arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170149: 3DMetal Tibial Cones.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170149
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026