510(k) · Cleared

Cleared

Kirschner Knee Modified

K961021510(k) TraditionalCleared Mar 17, 1997368-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 Mar 17, 1997 as substantially equivalent to K915132 (Biomet, Inc., 1992) and 1 other predicate after a 368-day review. Its family tree reaches back 1 generation to 1984. 7 later devices descend from it.

Decided: Mar 17, 1997
Review: 368 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K833921 (1984). 2 ancestors in all. 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK833921 Agc Total Knee ProsthesisBiomet, Inc. · 1984 · Recalled
This deviceK961021 Kirschner Knee ModifiedBiomet, Inc. · 1997
Descendant · cites it directly · 6 of its ownK122160 Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · Recalled
Descendant · 2 generations on · 3 of its ownK132873 Vanguard XP Knee SystemBiomet, Inc. · 2013 · Recalled
Descendant · 2 generations on · 2 of its ownK141407 Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · Recalled
Descendant · 2 generations on · 1 of its ownK153657 Vanguard XP Knee SystemBiomet, Inc. · 2016 · Recalled
Descendant · 2 generations on · 0 of its ownK190068 Vanguard XP Knee SystemZimmer, Inc. · 2019

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013high 2 (2013) · low 0 (2017)2026

Most influential descendants

Showing 5 of 7 · See all

K122160Vanguard XP Knee SystemBiomet Manufacturing Corp · 2013 · cites it directly6descendants
K132873Vanguard XP Knee SystemBiomet, Inc. · 2013 · 2 generations on3descendants
K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc. · 2014 · 2 generations on2descendants
K153657Vanguard XP Knee SystemBiomet, Inc. · 2016 · 2 generations on1descendant
K190068Vanguard XP Knee SystemZimmer, Inc. · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K833921	Agc Total Knee Prosthesis	Biomet, Inc.	1984	2
0 (this device)	K961021	Kirschner Knee Modified	Biomet, Inc.	1997	—
+1	K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	12
+2	K132873	Vanguard XP Knee System	Biomet, Inc.	2013	22
+2	K141407	Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral Trial	Biomet, Inc.	2014	1
+2	K153657	Vanguard XP Knee System	Biomet, Inc.	2016	1
+2	K190068	Vanguard XP Knee System	Zimmer, Inc.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	2	0
2014	2	0
2015	1	0
2016	1	0
2019	1	0

FIG. 1 — Lineage of K961021, 1984–2019Source: 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? (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	Applicant	Decided	Recalls
*	K915132	MCK Maximum Congruent Knee) Knee System Summary page 2 …, Biomet's Kirschner Knee Modified knee components are equivalent to aimost any knee components on the market, including: Maxim Total Knee System (Biomet, Inc.) 510(k)# K915132 cleared for market 2/11/92. AGC 2000 Total Knee Prosthesis (Biomet, Inc.) 510(k)# K833921 cleared for market 1/31/84.	Biomet, Inc.	1992	6
*	K833921	Agc Total Knee Prosthesis Summary page 2 …ents on the market, including: Maxim Total Knee System (Biomet, Inc.) 510(k)# K915132 cleared for market 2/11/92. AGC 2000 Total Knee Prosthesis (Biomet, Inc.) 510(k)# K833921 cleared for market 1/31/84.	Biomet, Inc.	1984	2

Also cleared against K915132: 13 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122160	Vanguard XP Knee System	Biomet Manufacturing Corp	2013	6

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K122160 (Biomet Manufacturing Corp, 2013) has gone furthest, with 6 descendants of its own.
13 other devices also cite its predicate K915132.

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	—

What is it indicated for?

Total knee replacement is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement in a wide size range of patients who require implantation due to degenerative bone disease such as rheumatoid arthwitis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle, pseudo-gout or complications from a falled prosthesis.

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/K961021 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961021: Kirschner Knee Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961021

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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