510(k) · Cleared

Cleared

Anatomic Total Knee Prosthesis

K000978510(k) TraditionalCleared Jun 22, 200087-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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 22, 2000 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.

Decided: Jun 22, 2000
Review: 87 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

64 later devices descend from it, 2 citing it directly.

This deviceK000978 Anatomic Total Knee ProsthesisBiomet, Inc. · 2000
Descendant · cites it directly · 43 of its ownK052687 Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006
Descendant · 2 generations on · 41 of its ownK094050 Itotal CR Knee Replacement SystemConformis, Inc. · 2010
Descendant · 3 generations on · 40 of its ownK103117 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · Recalled
Descendant · 3 generations on · 38 of its ownK112780 Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011
Descendant · 3 generations on · 36 of its ownK120316 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2004high 8 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 64 · See all

K052687Conformis, Inc. Total Knee Repair SystemConformis, Inc. · 2006 · cites it directly43descendants
K094050Itotal CR Knee Replacement SystemConformis, Inc. · 2010 · 2 generations on41descendants
K103117Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on40descendants
K112780Conformis Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on38descendants
K120316Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2012 · 3 generations on36descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000978	Anatomic Total Knee Prosthesis	Biomet, Inc.	2000	—
+1	K052687	Conformis, Inc. Total Knee Repair System	Conformis, Inc.	2006	—
+2	K094050	Itotal CR Knee Replacement System	Conformis, Inc.	2010	—
+3	K103117	Itotal Cruciate Retaining (CR) Knee Replacement System	Conformis, Inc.	2011	1
+3	K112780	Conformis Itotal Cruciate Retaining (CR) Knee Replacement System	Conformis, Inc.	2011	—
+3	K120316	Itotal Cruciate Retaining (CR) Knee Replacement System	Conformis, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2008	1	0
2010	1	0
2011	2	0
2012	5	0
2013	4	0
2014	6	0
2015	4	0
2016	5	0
2018	1	0
2019	2	0
2020	5	0
2021	8	0
2022	4	0
2023	7	0
2024	2	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K000978, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K052687	Conformis, Inc. Total Knee Repair System	Conformis, Inc.	2006	43
K033260	Aequos	Aap Implantate AG	2004	19

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?

Of its descendants, K052687 (Conformis, Inc., 2006) has gone furthest, with 43 descendants of its own.

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.

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	—

https://510kreport.com/device/K000978 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000978: Anatomic Total Knee Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000978

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026