510(k) · Cleared
Recalled · Class II · 2026The LINK® Endo-Model® Knee System
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 Jan 30, 2015 as substantially equivalent to K013385 (Zimmer, Inc., 2002) after an 87-day review. Its family tree reaches back 2 generations to 1996. 11 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 30, 2015
- Review
- 87 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945028 (1996). 11 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 1 generation backK013385 Nexgen Complete Knee Solution Rotatng Hinge KneeZimmer, Inc. · 2002 · Recalled
- This deviceK143179 The LINK® Endo-Model® Knee SystemWaldemar Link GmbH & Co. KG · 2015
- Descendant · cites it directly · 9 of its ownK152431 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled…Waldemar Link GmbH & Co. KG · 2016 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK212742 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee…Waldemar Link GmbH & Co. KG · 2021 · Recalled
- Descendant · 3 generations on · 1 of its ownK210010 GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG · 2016 · cites it directly9descendants
- K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020 · 2 generations on3descendants
- 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 · 2 generations on1descendant
- K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −1 | K013385 | Nexgen Complete Knee Solution Rotatng Hinge Knee | Zimmer, Inc. | 2002 | 2 |
| 0 (this device) | K143179 | The LINK® Endo-Model® Knee System | Waldemar Link GmbH & Co. KG | 2015 | — |
| +1 | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System… | Waldemar Link GmbH & Co. KG | 2016 | 16 |
| +2 | K202684 | GMK Total Knee System - TiNbN Coating | Medacta International S.A. | 2020 | — |
| +1 | K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | 2021 | 11 |
| +2 | K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with… | Waldemar Link GmbH & Co. KG | 2021 | 22 |
| +3 | K210010 | GMK Revision & Hinge Extension - TiNbN Coating | Medacta International S.A. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K013385 | Nexgen Complete Knee Solution Rotatng Hinge KneeSummary page 5…d Panel: Class II, Orthopedic / 87 Predicate Devices: NexGen® Complete Knee Solution Rotating Hinge Knee, manufactured by Zimmer, K013385, cleared January 9, 2002 Device Description: The LINK® Endo-Model® Knee System is constrained anti-… | 2002 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx… | 2016 | 9 |
| K202924 | LinkSymphoKnee System | 2021 | 2 |
| K220628 | LINK Endo-Model EVO Knee System | 2022 | 0 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | 2021 | 0 |
| K190181 | Instruments for LINK MEGASYSTEM-C Family | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2026 | Class II | Z-2934-2026 | Process change control | The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an… |
| May 22, 2024 | Class II | Z-2410-2024 | Process design | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique |
| May 22, 2024 | Class II | Z-2411-2024 | Process design | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique |
| Mar 18, 2021 | Class II | Z-2049-2023 | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. |
| Mar 18, 2021 | Class II | Z-2048-2023 | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. |
| Mar 18, 2021 | Class II | Z-2046-2023 | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. |
| Mar 18, 2021 | Class II | Z-2047-2023 | Device Design | The firm discovered through customer complaints that device segments may not meet specifications. |
The 5 latest of 7 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 19 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K152431 (Waldemar Link GmbH & Co. KG, 2016) has gone furthest, with 9 descendants of its own.
- 8 other devices also cite its predicate K013385.
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. 2015, 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® Knee System is 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. This device is intended for cemented use only unless a cementless modular stem is indicated for use. The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the…
Read the full statement (198 words)
The LINK® Endo-Model® Knee System is 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. This device is intended for cemented use only unless a cementless modular stem is indicated for use.
The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System 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® Endo-Model® Non-Rotating Hinge and Modular Non-Rotating Hinge Knee System are indicated for the following conditions:
1) Bone necroses.
2) Bicondylar arthrosis by completely damaged ligaments and muscular instability.
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°.
10) Valgus/Varus deformities 20-30°.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143179: The LINK® Endo-Model® Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143179
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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