510(k) · Cleared

Recalled · Class II · 2023

Zimmer Knee Joint Replacement Prostheses MR Labeling

K173057510(k) TraditionalCleared Mar 29, 2018182-day reviewClass II21 CFR 888.3560Recalls 2

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 Mar 29, 2018 as substantially equivalent to K872379 (Zimmer, Inc., 1987) and 35 other predicates after a 182-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it. It has been recalled 2 times.

Decided: Mar 29, 2018
Review: 182 days
Class: Class II
Product code: JWH
Recalls: 2
Predicates: 36

Its longest line of descent runs back 4 generations to K933785 (1995). 41 ancestors in all, the oldest K872379 (1987). 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
3 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
2 generations backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
1 generation backK042271 Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked…Zimmer, Inc. · 2004 · Recalled
This deviceK173057 Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc. · 2018
Descendant · cites it directly · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
Descendant · cites it directly · 1 of its ownK191625 Persona Revision Knee SystemZimmer, Inc. · 2019 · Recalled
Descendant · 2 generations on · 0 of its ownK243724 Persona® Revision Knee System (Persona Revision SoluTion™ Femoral…Zimmer, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK210829 Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK210551 Persona Revision Knee SystemZimmer, Inc. · 2021 · Recalled

Most influential descendants

Showing 5 of 5 · See all

K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · cites it directly4descendants
K191625Persona Revision Knee SystemZimmer, Inc. · 2019 · cites it directly1descendant
K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc. · 2025 · 2 generations on0descendants
K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc. · 2021 · 2 generations on0descendants
K210551Persona Revision Knee SystemZimmer, Inc. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K933785	Next Generation Knee System	Zimmer, Inc.	1995	83
−3	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components	Zimmer, Inc.	2002	6
−2	K031061	Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components	Zimmer, Inc.	2003	24
−1	K042271	Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene…	Zimmer, Inc.	2004	2
0 (this device)	K173057	Zimmer Knee Joint Replacement Prostheses MR Labeling	Zimmer, Inc.	2018	—
+1	K181947	Persona Revision Knee System	Zimmer, Inc.	2018	1
+1	K191625	Persona Revision Knee System	Zimmer, Inc.	2019	1
+2	K243724	Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)	Zimmer, Inc.	2025	—
+2	K210829	Persona Revision Knee System Femoral Metaphyseal Cones	Zimmer, Inc.	2021	—
+2	K210551	Persona Revision Knee System	Zimmer, Inc.	2021	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1989	1	0
1994	1	0
1995	3	0
1996	3	0
1997	5	0
1998	2	0
1999	1	0
2000	2	0
2001	3	0
2002	1	0
2003	2	0
2004	1	0
2005	3	0
2006	2	0
2007	5	0
2015	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	1	0
2021	2	0
2025	1	0

FIG. 1 — Lineage of K173057, 1995–2025Source: 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

Get a 510(k) Report

What was it cleared against? (36)

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
*	K872379	Insall/Burstein* II Modular Total Knee Summary page 25 …d, Metal/Polymer (21 CFR 888.3540) Predicate Device(s): Zimmer, Inc. K872379 Install/Burstein II Modular Total Knee K892800 MG II Porous Total Knee System…	Zimmer, Inc.	1987	11
*	K892800	MG II Porous Total Knee System Summary page 25 …Device(s): Zimmer, Inc. K872379 Install/Burstein II Modular Total Knee K892800 MG II Porous Total Knee System K933785 NexGen Knee System…	Zimmer, Inc.	1989	70
*	K933785	Next Generation Knee System Summary page 25 …K872379 Install/Burstein II Modular Total Knee K892800 MG II Porous Total Knee System K933785 NexGen Knee System K946150 Cruciate Retaining (Augmentable) and…	Zimmer, Inc.	1995	83
*	K946150	Cruciate Retaining (Augmentable) and Constrained Condylar Knee (CCK) Summary page 25 …K892800 MG II Porous Total Knee System K933785 NexGen Knee System K946150 Cruciate Retaining (Augmentable) and Constrained Condylar Knee…	Zimmer, Inc.	1995	—
*	K951185	Nexgen Complete Knee Solution 9MM Articular Surface Summary page 25 …K946150 Cruciate Retaining (Augmentable) and Constrained Condylar Knee K951185 NexGen Complete Knee Solution 9mm…	Zimmer, Inc.	1996	65
*	K960279	Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee Femoral… Summary page 26 …46 K173057 - Page 2 of 8 Articular Surface K960279 NexGen Complete Knee Solution Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Compon…	Zimmer, Inc.	1996	21
*	K963148	Nexgen Complete Knee Solution Summary page 26 …279 NexGen Complete Knee Solution Legacy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces K963148 NexGen Complete Knee Solution K991581 NexGen Complete Knee Solution Legacy Posterior Stabilized; LPS-Flex…	Zimmer, Inc.	1997	1
*	K991581	Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing… Summary page 26 …cy Posterior Stabilized/Constrained Condylar Knee Femoral Components/Articular Surfaces K963148 NexGen Complete Knee Solution K991581 NexGen Complete Knee Solution Legacy Posterior Stabilized; LPS-Flex Fixed Bearing Femoral and Arti…	Zimmer, Inc.	1999	7
*	K003910	Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining (CR)… Summary page 26 …lete Knee Solution K991581 NexGen Complete Knee Solution Legacy Posterior Stabilized; LPS-Flex Fixed Bearing Femoral and Articular Surface K003910 NexGen Complete Knee Solution Cross- Linked Polyethylene Cruciate Retaining Articular Surface Comp…	Zimmer, Inc.	2001	65
*	K023211	Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components Summary page 26 …ral and Articular Surface K003910 NexGen Complete Knee Solution Cross- Linked Polyethylene Cruciate Retaining Articular Surface Components K023211 NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components K031061 NexGen Porous, Uncemented…	Zimmer, Inc.	2002	6
*	K031061	Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components Summary page 26 …yethylene Cruciate Retaining Articular Surface Components K023211 NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components K031061 NexGen Porous, Uncemented Femoral and Tibial Baseplate Components K041100 NexGen Porous HA/TCP Uncemented…	Zimmer, Inc.	2003	24
*	K041100	Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate Components Summary page 26 …omplete Knee Solution Cruciate Retaining-Flex Femoral Components K031061 NexGen Porous, Uncemented Femoral and Tibial Baseplate Components K041100 NexGen Porous HA/TCP Uncemented Femoral and Tibial Baseplate Components K043101 NexGen Complete Knee Solut…	Zimmer, Inc.	2004	3
*	K043101	Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem Extensions Summary page 26 …Porous, Uncemented Femoral and Tibial Baseplate Components K041100 NexGen Porous HA/TCP Uncemented Femoral and Tibial Baseplate Components K043101 NexGen Complete Knee Solution MIS Tibial Components Locking Screw and Stem Extensions K042271…	Zimmer, Inc.	2005	22
*	K042271	Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular… Summary page 26 …Femoral and Tibial Baseplate Components K043101 NexGen Complete Knee Solution MIS Tibial Components Locking Screw and Stem Extensions K042271 NexGen Complete Knee Solution LPS-Flex Prolong Highly Cross-linked Polyethylene Articular Surfaces…	Zimmer, Inc.	2004	2
*	K052879	Nexgen Complete Knee Solution Mis Modular Tibial Plates and Keels Summary page 26 …nd Stem Extensions K042271 NexGen Complete Knee Solution LPS-Flex Prolong Highly Cross-linked Polyethylene Articular Surfaces K052879 NexGen Complete Knee Solution MIS Modular Tibial Plates and Keels K060370 NexGen Knee Gender Solutions Fem…	Zimmer, Inc.	2005	—
*	K060370	Nexgen Knee Gender Solutions Female (GSF) Femoral Components Summary page 26 …Prolong Highly Cross-linked Polyethylene Articular Surfaces K052879 NexGen Complete Knee Solution MIS Modular Tibial Plates and Keels K060370 NexGen Knee Gender Solutions Female (GSF) Femoral Components K062768 NexGen Complete Knee Solution Legacy…	Zimmer, Inc.	2006	17
*	K062768	Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and… Summary page 26 …NexGen Complete Knee Solution MIS Modular Tibial Plates and Keels K060370 NexGen Knee Gender Solutions Female (GSF) Femoral Components K062768 NexGen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Titanium Ti-6AL-4…	Zimmer, Inc.	2006	—
*	K072160	Nexgen Trabecular Metal Tibial Tray Summary page 26 …moral Components K062768 NexGen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and Titanium Ti-6AL-4V Alloy Femoral K072160 NexGen Trabecular Metal Tibial Tray K072281 NexGen Prolong All Poly Patella K072619 NexGen Complete Knee Solution…	Zimmer, Inc.	2007	1
*	K072281	Nexgen Prolong All-Poly Patella Summary page 26 …e Solution Legacy Posterior Stabilized Flex Fixed Bearing and Titanium Ti-6AL-4V Alloy Femoral K072160 NexGen Trabecular Metal Tibial Tray K072281 NexGen Prolong All Poly Patella K072619 NexGen Complete Knee Solution LPS-Flex Gender Solutions Female Por…	Zimmer, Inc.	2007	—
*	K072619	Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous… Summary page 26 …ilized Flex Fixed Bearing and Titanium Ti-6AL-4V Alloy Femoral K072160 NexGen Trabecular Metal Tibial Tray K072281 NexGen Prolong All Poly Patella K072619 NexGen Complete Knee Solution LPS-Flex Gender Solutions Female Porous Femoral Components K070695…	Zimmer, Inc.	2007	4
*	K070695	Zimmer Patellofemoral Joint Prosthesis Summary page 26 …2281 NexGen Prolong All Poly Patella K072619 NexGen Complete Knee Solution LPS-Flex Gender Solutions Female Porous Femoral Components K070695 Zimmer Patella Femoral Joint Prosthesis K013385 NexGen Complete Knee Solution Rotating Hinge Knee K152494…	Zimmer, Inc.	2007	5
*	K013385	Nexgen Complete Knee Solution Rotatng Hinge Knee Summary page 26 …NexGen Complete Knee Solution LPS-Flex Gender Solutions Female Porous Femoral Components K070695 Zimmer Patella Femoral Joint Prosthesis K013385 NexGen Complete Knee Solution Rotating Hinge Knee K152494 Zimmer NexGen Complete Knee Solution…	Zimmer, Inc.	2002	2
*	K152494	Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments Summary page 26 …e Porous Femoral Components K070695 Zimmer Patella Femoral Joint Prosthesis K013385 NexGen Complete Knee Solution Rotating Hinge Knee K152494 Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments K931651 Natural-Knee Congruent Tibial Ins…	Zimmer, Inc.	2015	1
*	K931651	Natural-Knee Congruent Tibial Insert with Screw Summary page 26 …is K013385 NexGen Complete Knee Solution Rotating Hinge Knee K152494 Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments K931651 Natural-Knee Congruent Tibial Insert with Screw K935789 Posterior Stabilized Apollo Knee System K936159…	Intermedics Orthopedics	1994	1
*	K935789	Posterior Stabilized Apollo Knee System Summary page 26 …Knee K152494 Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments K931651 Natural-Knee Congruent Tibial Insert with Screw K935789 Posterior Stabilized Apollo Knee System K936159 Natural-Knee II System K970498 Natural-Knee II Revision Femoral Sp…	Intermedics Orthopedics	1995	—
*	K936159	Natural-Knee II System Summary page 26 …n Tibial and Femoral Augments K931651 Natural-Knee Congruent Tibial Insert with Screw K935789 Posterior Stabilized Apollo Knee System K936159 Natural-Knee II System K970498 Natural-Knee II Revision Femoral Spacer…	Intermedics Orthopedics	1995	6
*	K970498	Natural-Knee II Revision Femoral Spacer Lugs Summary page 26 …gments K931651 Natural-Knee Congruent Tibial Insert with Screw K935789 Posterior Stabilized Apollo Knee System K936159 Natural-Knee II System K970498 Natural-Knee II Revision Femoral Spacer 47…	Intermedics Orthopedics	1997	—
*	K972501	Apollo Revision/Constrained Knee System Summary page 27 …47 K173057 - Page 3 of 8 Lugs K972501 Apollo Revision Constrained Knee System K973412 Natural-Knee II Constrained Knee System…	Sulzer Orthopedics, Inc.	1997	1
*	K973412	Natural-Knee II Constrained Knee System Summary page 27 …- Page 3 of 8 Lugs K972501 Apollo Revision Constrained Knee System K973412 Natural-Knee II Constrained Knee System K982903 Sulzer Orthopedics Fluted Stems…	Sulzer Orthopedics, Inc.	1997	2
*	K982903	Sulzer Orthopedics Fluted Stems Summary page 27 …K972501 Apollo Revision Constrained Knee System K973412 Natural-Knee II Constrained Knee System K982903 Sulzer Orthopedics Fluted Stems K983153 Natural-Knee II Posterior Stabilized…	Sulzer Orthopedics, Inc.	1998	—
*	K983153	Natural-Knee II Posterior Stabilized (P.S.) Condylar Knee Tibial Inserts Summary page 27 …K973412 Natural-Knee II Constrained Knee System K982903 Sulzer Orthopedics Fluted Stems K983153 Natural-Knee II Posterior Stabilized Condylar Knee Tibial Inserts…	Sulzer Orthopedics, Inc.	1998	1
*	K002335	Natural-Knee II System-Durasul Tibial Insert and Durasul All-Poly Patella Summary page 27 …K983153 Natural-Knee II Posterior Stabilized Condylar Knee Tibial Inserts K002335 Natural-Knee II System Durasul Tibial Insert and Durasul All Poly Patella…	Sulzer Orthopedics, Inc.	2000	8
*	K013031	Most Options System Summary page 27 …K002335 Natural-Knee II System Durasul Tibial Insert and Durasul All Poly Patella K013031 Most Options System K023528 Natural-Knee II Cemented Modular Tibial…	Sulzer Orthopedics, Inc.	2001	3
*	K023528	Natural-Knee II Cemented Modular Tibial Baseplate Summary page 27 …Tibial Insert and Durasul All Poly Patella K013031 Most Options System K023528 Natural-Knee II Cemented Modular Tibial Baseplate K031183…	Centerplus Orthopedics, Inc.	2003	5
*	K031183	Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate Summary page 27 …tions System K023528 Natural-Knee II Cemented Modular Tibial Baseplate K031183 Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate…	Centerpulse Orthopedics, Inc.	2003	—
*	K070214	Gender Solutions Natural-Knee Flex System Summary page 27 …K031183 Tibial Spacer for the Natural-Knee II Cemented Modular Tibial Baseplate K070214 Gender Solutions Natural-Knee Flex System Summary of Technological Characteristics: The purpose of this submissio…	Zimmer, Inc.	2007	63

Also cleared against K872379: 4 other devices →

What descends from it? (5)

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

Number	Device	Applicant	Decided	Descendants
K181947	Persona Revision Knee System	Zimmer, Inc.	2018	4
K191625	Persona Revision Knee System	Zimmer, Inc.	2019	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 19, 2023	Class II	Z-2092-2023	Under Investigation by firm	Device outer packaging was incorrectly labeled.
Oct 10, 2019	Class II	Z-0321-2020	Packaging change control	Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
29 of the 41 ancestors have a recall of any class.
Of its descendants, K181947 (Zimmer, Inc., 2018) has gone furthest, with 4 descendants of its own.
4 other devices also cite its predicate K872379.

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. 2018, 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…

Read the full statement (1,600 words)

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.

CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

NexGen Augments that may be used with cemented CR, CRA, PS, LPS, and LCCK femoral and tibial baseplate components are indicated for cemented use only.

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.

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

- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

- Collagen disorders, and/or avasculart 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.

NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Plates and Keels are intended for cemented use only

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.

CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.

Specific uses with CR-Flex or LPS-Flex femorals:

- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.

- The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

- The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

Specific Uses with NexGen LPS or LCCK femorals:

- The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees.

- The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces.

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.

The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only.

The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation).

Specific uses with CR-Flex GSF or LPS-Flex GSF femorals:

- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.

- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

- The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees.

- Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

- The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).

- History of patellar dislocation or patella fracture.

- Dysplasia-induced degeneration.

This device is intended for cemented use only.

This device is indicated for patients with:

- Moderate to severe knee instability.

- Significant bone loss and/or ligament deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle.

- Valgus, varus, or flexion deformities.

- The salvage of previously failed surgical attempts.

This device is intended for cemented use only.

The Natural-Knee System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

The Natural-Knee primary components without CSTi Porous Coating and all revision components are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary components are used, the medial and collateral ligaments must be intact.

The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact.

The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States.

This device is indicated for:

- Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

- Correctable valgus-varus deformity and moderate flexion contracture.

- Those patients with failed previous surgery where pain, deformity, or dysfunction persists.

- Revision of previously failed knee arthroplasty.

This device is intended for cemented use only.

Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).

Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal™ CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K173057 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173057: Zimmer Knee Joint Replacement Prostheses MR Labeling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173057

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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

Zimmer Knee Joint Replacement Prostheses MR Labeling

Line of descent and top descendants

Other ancestors by year cleared

Descendants by year cleared

What was it cleared against? (36)

What descends from it? (5)

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

Recalls of this device

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K872379

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