510(k) · Cleared
ClearedLINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
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 Jun 30, 2021 as substantially equivalent to K143179 (Waldemar Link GmbH & Co. KG, 2015) and 3 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jun 30, 2021
- Review
- 22 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K936079 (1994). 28 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 5 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 4 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 3 generations backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- 2 generations backK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- 1 generation backK152431 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled…Waldemar Link GmbH & Co. KG · 2016 · Recalled
- This deviceK211768 LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPEWaldemar Link GmbH & Co. KG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −5 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −4 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −3 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| −2 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| −1 | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System… | Waldemar Link GmbH & Co. KG | 2016 | 16 |
| 0 (this device) | K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2015 | 2 | 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? (4)
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 5…0: Knee joint femorotibial metal/polymer constrained cemented Name: prosthesis Classification Class II, Orthopedic / 87, KRO and Panel: Predicate K143179: LINK Endo-Model Knee System by Waldemar Link GmbH & Co KG Devices: [Primary predicate] K151008, LINK… | 2015 |
| * | K151008 | Link® Megasystem-C®Summary page 5…hopedic / 87, KRO and Panel: Predicate K143179: LINK Endo-Model Knee System by Waldemar Link GmbH & Co KG Devices: [Primary predicate] K151008, LINK Megasystem-C with Endo-Model SL Knee System, by Waldemar Link GmbH & Co KG K821476/S01:… | 2015 |
| * | K821476 | Bard Endo Link Intracondylar RotatingSummary page 5…[Primary predicate] K151008, LINK Megasystem-C with Endo-Model SL Knee System, by Waldemar Link GmbH & Co KG K821476/S01: LINK Endo-Model Rotating Hinge Revision Knee System by Waldemar Link GmbH & Co KG, (original submission by… | 1982 |
| * | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Summary page 6…9) Valgus/Varus deformities 15-20°. 10) Valgus/Varus deformities 20-30°. Comparison to The Endo-Model Knee System (K143179, K152431) includes femoral segments Predicate Device: (augments) made of titanium for use with the Endo-Model Knee. This submission… | 2016 |
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 27 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- 16 of the 28 ancestors have a recall of any class.
- 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. 2021, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211768 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211768: LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211768
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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