510(k) · Cleared

Cleared

Nexgen Prolong All-Poly Patella

K072281510(k) SpecialCleared Sep 6, 200721-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

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

Cleared on Sep 6, 2007 as substantially equivalent to K933785 (Zimmer, Inc., 1995) after a 21-day review. Its family tree reaches back 1 generation to 1995. 97 later devices descend from it.

Decided: Sep 6, 2007
Review: 21 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933785 (1995). 97 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
This deviceK072281 Nexgen Prolong All-Poly PatellaZimmer, Inc. · 2007
Descendant · cites it directly · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
Descendant · 3 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
Descendant · 3 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
Descendant · 2 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012

Showing 5 of 97 descendants. See all descendants

Descendants cleared per year

2008high 13 (2021) · low 1 (2008)2026

Most influential descendants

Showing 5 of 97 · See all

K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · cites it directly78descendants
K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 3 generations on34descendants
K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 3 generations on28descendants
K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 2 generations on23descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933785	Next Generation Knee System	Zimmer, Inc.	1995	83
0 (this device)	K072281	Nexgen Prolong All-Poly Patella	Zimmer, Inc.	2007	—
+1	K081023	Evolis Total Knee System	Medacta International S.A.	2008	1
+2	K090988	GMK Total Knee System	Medacta International S.A.	2009	1
+3	K102437	GMK Revision Knee System	Medacta International S.A.	2010	—
+3	K103170	GMK Revision Knee SC Liners	Medacta International S.A.	2011	—
+2	K113571	GMK Resufacing Patella Size 4	Medacta International	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	2	0
2010	2	0
2011	6	0
2012	8	0
2013	6	0
2014	5	0
2015	2	0
2016	2	0
2017	5	0
2018	5	0
2019	2	0
2020	6	0
2021	13	0
2022	5	0
2023	5	0
2024	2	0
2025	11	0
2026	9	0

FIG. 1 — Lineage of K072281, 1995–2026Source: 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? (1)

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
*	K933785	Next Generation Knee System Summary page 1 …21 CFR § 888.3560 Predicate Device: NexGen Knee System, manufactured by Zimmer, Inc., K933785, cleared January 30, 1995 Device Description: The proposed device is part of the NexGen system…	Zimmer, Inc.	1995	83

Also cleared against K933785: 14 other devices →

What descends from it? (97)

See all 97

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

Number	Device	Applicant	Decided	Descendants
K081023	Evolis Total Knee System	Medacta International S.A.	2008	78
K103733	United U2 Xpe Total Knee System	United Orthopedic Corporation	2011	8
K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	5
K200122	MOTO PFJ System	Medacta International S.A.	2020	2
K122975	GKS Prime Flex CR Total Knee System	Permedica	2012	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?

Its one ancestor has a recall.
Of its descendants, K081023 (Medacta International S.A., 2008) has gone furthest, with 78 descendants of its own.
14 other devices also cite its predicate K933785.

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. 2007, 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?

This device is indicated for patients with severe knee pain and disability due to:

- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

- Collagen disorders and/or 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.

- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

This device is indicated for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072281 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072281: Nexgen Prolong All-Poly Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072281

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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