510(k) · Cleared

Cleared

LINK GEMINI SL Total Knee System

K182872510(k) TraditionalCleared Apr 3, 2019173-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Waldemar Link GmbH & Co. KG · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Apr 3, 2019 as substantially equivalent to K923277 (Encore Orthopedics, Inc., 1993) and 2 other predicates after a 173-day review. Its family tree reaches back 5 generations to 1994. 8 later devices descend from it.

Decided: Apr 3, 2019
Review: 173 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K936079 (1994). 20 ancestors in all, the oldest K810520 (1981). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

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 deviceK182872 LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
Descendant · cites it directly · 2 of its ownK202924 LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · Recalled
Descendant · cites it directly · 2 of its ownK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020
Descendant · 2 generations on · 1 of its ownK212839 Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021
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 · 0 of its ownK230471 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating…Waldemar Link GmbH & Co. KG · 2023

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2019high 3 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 8 · See all

K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · cites it directly2descendants
K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020 · cites it directly2descendants
K212839Opulent TiNbN Coated KneeMeril Healthcare Pvt., Ltd. · 2021 · 2 generations on1descendant
K212742GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…Waldemar Link GmbH & Co. KG · 2021 · cites it directly1descendant
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)	K182872	LINK GEMINI SL Total Knee System	Waldemar Link GmbH & Co. KG	2019	—
+1	K202924	LinkSymphoKnee System	Waldemar Link GmbH & Co. KG	2021	11
+1	K200912	Freedom (R) - TiNbN Coated Knee	Maxx Orthopedics, Inc.	2020	—
+2	K212839	Opulent TiNbN Coated Knee	Meril Healthcare Pvt., Ltd.	2021	—
+1	K212742	GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with…	Waldemar Link GmbH & Co. KG	2021	22
+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	2	0
2000	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2019	1	0
2020	1	0
2021	3	0
2022	2	0
2023	1	0

FIG. 1 — Lineage of K182872, 1994–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K923277	Foundation Knee System Summary page 4 …code JWH Classification Class II, Orthopedic / 87 and Panel: Predicate Foundation® Knee System, manufactured by DJO surgical, Devices: K923277, cleared 02/09/1993 Foundation® Posterior Stabilized Knee, manufactured by DJO surgical, K9335…	Encore Orthopedics, Inc.	1993	4
*	K933539	Foundation Posterior Stabilized Knee Summary page 4 …red by DJO surgical, Devices: K923277, cleared 02/09/1993 Foundation® Posterior Stabilized Knee, manufactured by DJO surgical, K933539, cleared 11/08/1994 Foundation® Knee System with TiNbN Coating, manufactured by DJO surgical,…	Encore Orthopedics, Inc.	1994	—
*	K122239	Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating… Summary page 4 …y DJO surgical, K933539, cleared 11/08/1994 Foundation® Knee System with TiNbN Coating, manufactured by DJO surgical, K122239, cleared 04/11/2013 Device The LINK® GEMINI® SL® Total Knee System is a semi-constrained, Description: patellofemor…	Encore Medical L.P.	2013	—

Also cleared against K923277: 10 other devices →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K202924	LinkSymphoKnee System	Waldemar Link GmbH & Co. KG	2021	2
K200912	Freedom (R) - TiNbN Coated Knee	Maxx Orthopedics, Inc.	2020	2
K212742	GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK…	Waldemar Link GmbH & Co. KG	2021	1
K191755	SPAR-K Instruments (for use with Gemini SL Total Knee System)	Waldemar Link GmbH & Co. KG	2019	0

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 25 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
10 of the 20 ancestors have a recall of any class.
Of its descendants, K202924 (Waldemar Link GmbH & Co. KG, 2021) has gone furthest, with 2 descendants of its own.
10 other devices also cite its predicate K923277.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)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 LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to:

- Degenerative, post-traumatic or rheumatoid arthritis;

- Avascular necrosis of the femoral condyle:

- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

- 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.

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/K182872 · printed Nov 4, 2026

Cite this page

510(k) Report. “K182872: LINK GEMINI SL Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182872

Report an extraction error

Are you the manufacturer?

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