510(k) · Cleared

Recalled · Class II · 2022

Insall/Burstein* II Modular Total Knee

K872379510(k) TraditionalCleared Oct 28, 1987131-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

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

Cleared on Oct 28, 1987 after a 131-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 55 later devices descend from it. It has been recalled 11 times.

Decided: Oct 28, 1987
Review: 131 days
Class: Class II
Product code: JWH
Recalls: 11
Predicates: 0

55 later devices descend from it, 5 citing it directly.

This deviceK872379 Insall/Burstein* II Modular Total KneeZimmer, Inc. · 1987
Descendant · cites it directly · 42 of its ownK090705 Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · Recalled
Descendant · 2 generations on · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
Descendant · 3 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
Descendant · 3 generations on · 24 of its ownK153310 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015
Descendant · 3 generations on · 24 of its ownK153075 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

1997high 9 (2021) · low 0 (1998)2026

Most influential descendants

Showing 5 of 55 · See all

K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 2009 · cites it directly42descendants
K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · 2 generations on33descendants
K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 3 generations on27descendants
K153310Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants
K153075Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2015 · 3 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872379	Insall/Burstein* II Modular Total Knee	Zimmer, Inc.	1987	—
+1	K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	1
+2	K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	—
+3	K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	—
+3	K153310	Klassic Knee System	Total Joint Orthopedics, Inc.	2015	—
+3	K153075	Klassic Knee System	Total Joint Orthopedics, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	1	0
2003	1	0
2006	1	0
2009	1	0
2011	1	0
2012	2	0
2014	2	0
2015	5	0
2016	3	0
2017	1	0
2018	3	0
2019	4	0
2020	3	0
2021	9	0
2022	4	0
2023	8	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K872379, 1987–2026Source: 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

Get a 510(k) Report

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? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K090705	Balanced Knee System Ultracongruent Tibial Insert	Ortho Development Corp.	2009	42
K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	5
K013906	HLS Noetos System	Tornier	2002	3
K061433	Vanguard Anatomic Patella Groove (Apg) / Vanguard V Groove	Biomet Manufacturing, Inc.	2006	0
K964951	Kinemax Plus Tibial Spacers	Howmedica Corp.	1997	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 6, 2022	Class II	Z-0468-2023	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used…
Dec 6, 2022	Class II	Z-0471-2023	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used…
Dec 6, 2022	Class II	Z-0466-2023	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used…
Dec 6, 2022	Class II	Z-0467-2023	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used…
Dec 6, 2022	Class II	Z-0469-2023	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used…
Dec 6, 2022	Class II	Z-0470-2023	Under Investigation by firm	Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used…
Jan 11, 2016	Class II	Z-1133-2016	Packaging	As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Jan 11, 2016	Class II	Z-1149-2016	Packaging	As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Oct 11, 2013	Class II	Z-1021-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…
Oct 11, 2013	Class II	Z-1023-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…
Sep 21, 2012	Class II	Z-0437-2013	Process change control	Zimmer is initiating a lot specific recall of the NexGen Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a…

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?

Of its descendants, K090705 (Ortho Development Corp., 2009) has gone furthest, with 42 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/K872379 · printed Nov 4, 2026

Cite this page

510(k) Report. “K872379: Insall/Burstein* II Modular Total Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872379

Report an extraction error

Are you the manufacturer?

Record history

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