510(k) · Cleared

Recalled · Class II · 2025

LinkSymphoKnee System

K202924510(k) TraditionalCleared May 13, 2021226-day reviewClass II21 CFR 888.3560Recalls 11

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 May 13, 2021 as substantially equivalent to K182872 (Waldemar Link GmbH & Co. KG, 2019) and 7 other predicates after a 226-day review. Its family tree reaches back 6 generations to 1994. 2 later devices descend from it. It has been recalled 11 times.

Decided: May 13, 2021
Review: 226 days
Class: Class II
Product code: JWH
Recalls: 11
Predicates: 8

Its longest line of descent runs back 6 generations to K936079 (1994). 32 ancestors in all, the oldest K810520 (1981). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

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 deviceK202924 LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021
Descendant · cites it directly · 0 of its ownK230471 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating…Waldemar Link GmbH & Co. KG · 2023
Descendant · cites it directly · 0 of its ownK220628 LINK Endo-Model EVO Knee SystemWaldemar Link GmbH & Co. KG · 2022

Most influential descendants

Showing 2 of 2 · See all

K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG · 2023 · cites it directly0descendants
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)	K202924	LinkSymphoKnee System	Waldemar Link GmbH & Co. KG	2021	—
+1	K230471	LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface	Waldemar Link GmbH & Co. KG	2023	—
+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	4	0
1996	6	0
2000	1	0
2002	2	0
2004	1	0
2005	1	0
2007	1	0
2015	1	0
2019	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2023	1	0

FIG. 1 — Lineage of K202924, 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

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What was it cleared against? (8)

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
*	K182872	LINK GEMINI SL Total Knee System Summary page 4 …cation and Panel: Class II, Orthopedic / 87 Predicate Devices: Primary Predicate: Waldemar Link LINK GEMINI SL Total Knee System: K182872 Additional Predicates: Smith & Nephew Legion Knee System: K072531, K0411…	Waldemar Link GmbH & Co. KG	2019	—
*	K072531	Legion Stem with Holes Summary page 4 …aldemar Link LINK GEMINI SL Total Knee System: K182872 Additional Predicates: Smith & Nephew Legion Knee System: K072531, K041106, K043440; K953274; K951987…	Smith & Nephew, Inc.	2007	—
*	K041106	Revision Knee System Summary page 4 …ink LINK GEMINI SL Total Knee System: K182872 Additional Predicates: Smith & Nephew Legion Knee System: K072531, K041106, K043440; K953274; K951987…	Smith & Nephew, Inc.	2004	1
*	K043440	Smith & Nephew, Inc. Revision Knee System Summary page 4 …GEMINI SL Total Knee System: K182872 Additional Predicates: Smith & Nephew Legion Knee System: K072531, K041106, K043440; K953274; K951987…	Smith & Nephew, Inc.	2005	7
*	K953274	Genesis Porous Tibial Trays & Revision Knee System Summary page 4 …Additional Predicates: Smith & Nephew Legion Knee System: K072531, K041106, K043440; K953274; K951987 K202924 Page 2 of 4…	Smith & Nephew Richards, Inc.	1996	—
*	K951987	Genesis II Total Knee System Summary page 4 …Additional Predicates: Smith & Nephew Legion Knee System: K072531, K041106, K043440; K953274; K951987 K202924 Page 2 of 4…	Smith & Nephew Richards, Inc.	1995	6
*	K143179	The LINK® Endo-Model® Knee System Summary page 5 …= Page 5 === K202924 Page 2 of 4 Waldemar Link Endo-Model Knee System: K143179 Waldemar Link Endo-Model Knee System with PorEx (TiNbN) coating: K152431 Device Desc…	Waldemar Link GmbH & Co. KG	2015	7
*	K152431	LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx… Summary page 5 …Waldemar Link Endo-Model Knee System: K143179 Waldemar Link Endo-Model Knee System with PorEx (TiNbN) coating: K152431 Device Description: The LinkSymphoKnee System is available in multiple versions with different applicati…	Waldemar Link GmbH & Co. KG	2016	16

Also cleared against K182872: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K230471	LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface	Waldemar Link GmbH & Co. KG	2023	0
K220628	LINK Endo-Model EVO Knee System	Waldemar Link GmbH & Co. KG	2022	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 31, 2025	Class II	Z-2541-2025	Under Investigation by firm	Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Apr 3, 2025	Class II	Z-1701-2025	Nonconforming Material/Component	The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Apr 3, 2025	Class II	Z-1702-2025	Nonconforming Material/Component	The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Apr 3, 2025	Class II	Z-1699-2025	Nonconforming Material/Component	The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Apr 3, 2025	Class II	Z-1700-2025	Nonconforming Material/Component	The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Feb 14, 2025	Class II	Z-1373-2025	Labeling Change Control	A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Feb 14, 2025	Class II	Z-1372-2025	Labeling Change Control	A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Feb 14, 2025	Class II	Z-1374-2025	Labeling Change Control	A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Apr 25, 2023	Class II	Z-1674-2023	Under Investigation by firm	Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Dec 23, 2022	Class II	Z-2067-2023	Component change control	Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Dec 23, 2022	Class II	Z-2066-2023	Component change control	Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

The 5 latest of 11 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 5.0 years on median.
18 of the 32 ancestors have a recall of any class.
Of its descendants, K230471 (Waldemar Link GmbH & Co. KG, 2023) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K182872.

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. 2021, 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?

General:

The LinkSymphoKnee System is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions.

This device is intended for cemented use only unless a cementless modular stem is indicated for use.

Indications:

• Primary degenerative arthritis / osteoarthritis

• Secondary arthritis resulting from rheumatoid arthritis

• Fracture

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K202924 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202924: LinkSymphoKnee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202924

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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