510(k) · Cleared
Recalled · Class II · 2023LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on May 9, 2016 as substantially equivalent to K143179 (Waldemar Link GmbH & Co. KG, 2015) and 2 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it. It has been recalled 16 times.
- Decided
- May 9, 2016
- Review
- 257 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 16
- Predicates
- 3
Its longest line of descent runs back 5 generations to K936079 (1994). 24 ancestors in all, the oldest K810520 (1981). 9 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 4 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 3 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 2 generations backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- 1 generation backK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- This deviceK152431 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled…Waldemar Link GmbH & Co. KG · 2016
- Descendant · cites it directly · 3 of its ownK202684 GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020
- Descendant · cites it directly · 2 of its ownK202924 LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK212742 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK210010 GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021
- Descendant · 2 generations on · 0 of its ownK230471 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating…Waldemar Link GmbH & Co. KG · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020 · cites it directly3descendants
- K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · cites it directly2descendants
- K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG · 2021 · cites it directly1descendant
- K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021 · 2 generations on1descendant
- K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −4 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −3 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −2 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| −1 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| 0 (this device) | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System… | Waldemar Link GmbH & Co. KG | 2016 | — |
| +1 | K202684 | GMK Total Knee System - TiNbN Coating | Medacta International S.A. | 2020 | — |
| +1 | K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | 2021 | 11 |
| +1 | K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with… | Waldemar Link GmbH & Co. KG | 2021 | 22 |
| +2 | K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021 | — |
| +2 | K230471 | LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface | Waldemar Link GmbH & Co. KG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 KRO? 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 KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K143179 | The LINK® Endo-Model® Knee SystemSummary page 4…coating; Foundation PS Knee System with TiNbN coating; 3D Knee System with TiNbN coating by DJO Surgical, K122239, cleared April 11, 2013 LINK® Endo-Model® Knee System, K143179, cleared January 30, 2015 LINK® Sled Uni-Compartment Knee System, K954186, cleared January 26, 1996 The LINK® Endo-Model® Knee… | 2015 |
| * | K954186 | Sled Unicompartment Knee SystemSummary page 4…TiNbN coating by DJO Surgical, K122239, cleared April 11, 2013 LINK® Endo-Model® Knee System, K143179, cleared January 30, 2015 LINK® Sled Uni-Compartment Knee System, K954186, cleared January 26, 1996 The LINK® Endo-Model® Knee System is constrained anti- luxation total knee prosthesis. Retaining the… | 1996 |
| * | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Summary page 4…SX Class I, Orthopedic / 87 Foundation Knee System with TiNbN coating; Foundation PS Knee System with TiNbN coating; 3D Knee System with TiNbN coating by DJO Surgical, K122239, cleared April 11, 2013 LINK® Endo-Model® Knee System, K143179, cleared January 30, 2015 LINK® Sled Uni-Compartment Knee System… | 2013 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202684 | GMK Total Knee System - TiNbN Coating | 2020 | 3 |
| K202924 | LinkSymphoKnee System | 2021 | 2 |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK… | 2021 | 1 |
| K220628 | LINK Endo-Model EVO Knee System | 2022 | 0 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2023 | Class II | Z-1544-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1549-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1552-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1543-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1551-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1550-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1541-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1554-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1540-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1553-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1548-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1545-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1539-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1547-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1542-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
| Mar 21, 2023 | Class II | Z-1546-2023 | Labeling design | Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the… |
The 5 latest of 16 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 13 of the 24 ancestors have a recall of any class.
- Of its descendants, K202684 (Medacta International S.A., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K143179.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, 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 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
The LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. These devices are intended for cemented use only. The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with PorEx® (TiNbN) coating are…
Read the full statement (151 words)
The LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are indicated for patients with severe
joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint
fractures which disallow an osteosynthetic reconstruction. These devices are intended for cemented use only.
The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with PorEx® (TiNbN) coating are
indicated for the following conditions:
1) Bone necroses
2) Bicondylar arthrosis by partly damaged collateral ligaments
3) Revision after primary total knee replacement
4) Revision surgery after hinge knee or rotational knee joint
5) Revision surgery by insufficient / inadequate bone mass
6) Arthrosis of patella flange
7) Valgus/Varus deformities <10°
8) Valgus/Varus deformities 10-15°
9) Valgus/Varus deformities 15-20°
The LINK® Sled Knee System with PorEx® (TiNbN) coating is indicated for the following conditions:
1) Unicondylar arthrosis by intact ligaments including both cruciate ligaments
2) Valgus/Varus deformities <10°
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152431: LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152431
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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