510(k) · Cleared
Recalled · Class II · 2024GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Waldemar Link GmbH & Co. KG · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 16, 2021 as substantially equivalent to K182872 (Waldemar Link GmbH & Co. KG, 2019) and 1 other predicate after a 17-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it. It has been recalled 22 times.
- Decided
- Sep 16, 2021
- Review
- 17 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 22
- Predicates
- 2
Its longest line of descent runs back 6 generations to K936079 (1994). 26 ancestors in all, the oldest K810520 (1981). 1 later device descends from it, 1 citing it directly.
- 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 deviceK212742 GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee…Waldemar Link GmbH & Co. KG · 2021
- Descendant · cites it directly · 0 of its ownK220628 LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG · 2022
Most influential descendants
Showing 1 of 1 · See all- K220628LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG · 2022 · cites it directly0descendants
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) | K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with… | Waldemar Link GmbH & Co. KG | 2021 | — |
| +1 | 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 | 3 | 0 |
| 1996 | 4 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 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 |
|---|---|---|---|
| * | K182872 | LINK GEMINI SL Total Knee SystemSummary page 5…Class II, Orthopedic / 87 Predicate Devices: Primary Predicate: GEMINI SL Total Knee System, K182872 Endo-Model Knee System with PorEx (TiNbN) coating, Sled… | 2019 |
| * | K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Summary page 5…Endo-Model Knee System with PorEx (TiNbN) coating, Sled Knee System with PorEx (TiNbN) coating, K152431 Page 1 of 5… | 2016 |
| † | K202924 | LinkSymphoKnee System | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220628 | LINK Endo-Model EVO Knee System | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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 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… |
| May 24, 2022 | Class II | Z-1380-2022 | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. |
| May 24, 2022 | Class II | Z-1377-2022 | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. |
| May 24, 2022 | Class II | Z-1378-2022 | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. |
| May 24, 2022 | Class II | Z-1379-2022 | Nonconforming Material/Component | There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure. |
The 5 latest of 22 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 27 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 14 of the 26 ancestors have a recall of any class.
- Of its descendants, K220628 (Waldemar Link GmbH & Co. KG, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K182872.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/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 · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
The GEMINI SL Total Knee System is indicated for patients suffering from disability due to: 1) Degenerative, post-traumatic or rheumatoid arthritis; 2) Avascular necrosis of the femoral condyle; 3) Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; 4) Moderate valgus, varus or flexion deformities. This device may also be indicated in the salvage of previously failed surgical…
Read the full statement (233 words)
The GEMINI SL Total Knee System is indicated for patients suffering from disability due to:
1) Degenerative, post-traumatic or rheumatoid arthritis;
2) Avascular necrosis of the femoral condyle;
3) Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
4) Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts.
The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.
The Endo-Model and Sled Knee Systems with LINK 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 Endo-Model Rotating Hinge and Modular Rotating Hinge Knee System with LINK 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 Sled Knee System with LINK 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/K212742 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212742: GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212742
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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