510(k) · Cleared
ClearedLINK Endo-Model EVO 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 May 3, 2022 as substantially equivalent to K143179 (Waldemar Link GmbH & Co. KG, 2015) and 4 other predicates after a 60-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- May 3, 2022
- Review
- 60 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K936079 (1994). 36 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
- 6 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
- 5 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
- 4 generations backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
- 3 generations backK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
- 2 generations backK152431 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled…Waldemar Link GmbH & Co. KG · 2016 · Recalled
- 1 generation backK202924 LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · Recalled
- This deviceK220628 LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936079 | Ecactech Porous Coated Finned Tibial Tray Compnent | Exactech, Inc. | 1994 | — |
| −6 | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | Exactech, Inc. | 2001 | — |
| −5 | K030686 | Optetrak Total Knee System - Molded Metal-Back Tibial Component | Exactech, Inc. | 2003 | — |
| −4 | K100900 | Motivation Knee System | Encore Medical L.P. | 2010 | 4 |
| −3 | K122239 | Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn… | Encore Medical L.P. | 2013 | — |
| −2 | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System… | Waldemar Link GmbH & Co. KG | 2016 | 16 |
| −1 | K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | 2021 | 11 |
| 0 (this device) | K220628 | LINK Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 2022 | — |
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 | 4 | 0 |
| 1996 | 6 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (5)
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…assification and Panel: Class II, Orthopedic / 87 Predicate Devices: Primary Predicate Waldemar Link LINK Endo-Model Knee System: K143179 Additional Predicates Waldemar Link LINK Endo-Model Knee System with Por… | 2015 |
| * | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Summary page 5…Additional Predicates Waldemar Link LINK Endo-Model Knee System with PorEx (TiNbN) coating: K152431, K212742 Waldemar Link LinkSymphoKnee: K202924 Waldemar Link LINK MEGASYS… | 2016 |
| * | K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Summary page 5…Additional Predicates Waldemar Link LINK Endo-Model Knee System with PorEx (TiNbN) coating: K152431, K212742 Waldemar Link LinkSymphoKnee: K202924 Waldemar Link LINK MEGASYSTEM-C: K1… | 2021 |
| * | K202924 | LinkSymphoKnee SystemSummary page 5…demar Link LINK Endo-Model Knee System with PorEx (TiNbN) coating: K152431, K212742 Waldemar Link LinkSymphoKnee: K202924 Waldemar Link LINK MEGASYSTEM-C: K151008 Device Description: The LINK Endo-Model EVO Knee Sy… | 2021 |
| * | K151008 | Link® Megasystem-C®Summary page 5…coating: K152431, K212742 Waldemar Link LinkSymphoKnee: K202924 Waldemar Link LINK MEGASYSTEM-C: K151008 Device Description: The LINK Endo-Model EVO Knee System is available in multiple versions wi… | 2015 |
| † | K200113 | LINK TrabecuLink Tibial Cones | 2020 |
| † | K201364 | LINK TrabecuLink Femoral Cones | 2020 |
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 28 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 22 of the 36 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. 2022, 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?
General Indications LINK Endo-Model EVO Knee System: The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: All LINK Endo-Model EVO components: * Primary and secondary…
Read the full statement (332 words)
General Indications LINK Endo-Model EVO Knee System:
The LINK Endo-Model EVO Knee System is intended for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures.
This device is intended for cemented use only unless a cementless modular stem is indicated for use.
Indications:
All LINK Endo-Model EVO components:
* Primary and secondary osteoarthritis.
* Rheumatoid arthritis.
* Revision after primary or revision total knee replacement.
* Bone necroses which won't compromise the successful implantation of a hinged total knee endoprosthesis.
* Varus and valgus deformity with contracture or laxity of the medial or lateral stabilizers.
The LINK Endo-Model EVO Pure Hinge is additionally indicated for:
* Extreme cases of varus/valgus deformities (20-300), rheumatoid arthritis, muscular deficiency and any kind of genu laxum.
* Oncological and revision surgery in lower limb (in conjunction with the Endo-Model EVO -W and the Megasystem-C)
The LINK Endo-Model EVO Rotating Hinge is additionally indicated for:
* Oncological and revision surgery in lower limb (in conjunction with the Endo-Model EVO -W and the Megasystem-C)
General Indications Link OptiStems:
The Link OptiStems are for use with the following LINK knee femoral components, both intracondylar and distal femoral replacement versions: LINK Endo-Model SL, LINK Endo-Model EVO-M, and LINK Endo-Model EVO-W and are indicated for mobility limiting diseases, fractures or defects of the knee joint, distal femur or proximal tibia which cannot be treated by conservative or osteosynthetic procedures.
The Link OptiStems cemented are intended for cemented use only. The Link OptiStems cementless are intended for cementless use only.
Indications:
* Revision arthroplasty due to juxta-articular bone defects.
* Revision of loosened femoral prosthesis components by peri-/subprosthetic fracture.
* Bone deficiencies, e.g. due to tumors, as well as in large post-revision and posttrauma segmental bone defects.
* Oncological and revision surgery in the area of the distal femur (in conjunction with Endo-Model SL Rotational and Hinge Knee Prostheses or LINK Endo-Model EVO - M - W).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220628: LINK Endo-Model EVO 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/K220628
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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