510(k) · Cleared
ClearedLINK TrabecuLink Femoral Cones
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jul 17, 2020 as substantially equivalent to K103517 (Zimmer Trabecular Metal Technology, Inc., 2011) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Jul 17, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K982302 (1998). 20 ancestors in all, the oldest K980781 (1998). No later device cites it as a predicate yet.
- Root · 8 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 7 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 6 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 5 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- 4 generations backK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- 3 generations backK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
- 2 generations backK153595 Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016
- 1 generation backK200113 LINK TrabecuLink Tibial ConesWaldemar Link GmbH & Co. KG · 2020
- This deviceK201364 LINK TrabecuLink Femoral ConesWaldemar Link GmbH & Co. KG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −7 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −6 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −5 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| −4 | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| −3 | K143393 | Triathlon Tritanium Cone Augments | Stryker Orthopaedics | 2015 | 1 |
| −2 | K153595 | Optetrak Logic Metaphyseal Cones | Exactech, Inc. | 2016 | — |
| −1 | K200113 | LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG | 2020 | — |
| 0 (this device) | K201364 | LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 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 |
|---|---|---|---|
| * | K103517 | Trabecular Metal Femoral Cone AugmentsSummary page 4…d prosthesis; 21 CFR §888.3565, product code MBH Classification Class II, Orthopedic / 87 and Panel: Predicate NexGen® Trabecular MetalTM Femoral Cone Augments (K103517) Devices: [primary]; LINK® TrabecuLink® Tibial Cones (K200113) Reference NexGen® Trabecular MetalTM Tibial Cone A… | 2011 |
| * | K200113 | LINK TrabecuLink Tibial ConesSummary page 4…s II, Orthopedic / 87 and Panel: Predicate NexGen® Trabecular MetalTM Femoral Cone Augments (K103517) Devices: [primary]; LINK® TrabecuLink® Tibial Cones (K200113) Reference NexGen® Trabecular MetalTM Tibial Cone Augments (K102896) Devices: Device The LINK® TrabecuLink® Fem… | 2020 |
| † | K102896 | Trabecular Metal Tibial Cone Augments | 2010 |
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 22 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 6 of the 20 ancestors have a recall of any class.
- 3 other devices also cite its predicate K103517.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The LINK TrabecuLink Femoral and Tibial Cones are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis and joint fractures which disallow an osteosynthetic reconstruction.
The LINK TrabecuLink Femoral and Tibial Cones are indicated for the following conditions:
- Surgeries which require implantation of a total knee endoprosthesis after severe degeneration or bone loss, traumata, or other pathologies.
The device is intended for uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201364: LINK TrabecuLink Femoral Cones.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201364
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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