510(k) · Cleared

Cleared

ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer

K113296510(k) TraditionalCleared Sep 14, 2012311-day reviewClass II21 CFR 888.3358

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Sep 14, 2012 as substantially equivalent to K992667 (Zimmer, Inc., 1999) and 9 other predicates after a 311-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.

Decided: Sep 14, 2012
Review: 311 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 10

Its longest line of descent runs back 7 generations to K921308 (1994). 87 ancestors in all, the oldest K845025 (1985). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 7 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
6 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
5 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
4 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
3 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
2 generations backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
1 generation backK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010 · Recalled
This deviceK113296 ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or…Zimmer, Inc. · 2012
Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025

Most influential descendants

Showing 2 of 2 · See all

K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · cites it directly1descendant
K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K921308	HG Multilock Hip Prosthesis W/ TI-Nidium	Zimmer, Inc.	1994	1
−6	K972893	Partnership Revision Femoral Stems	Howmedica Corp.	1997	—
−5	K983404	Type 3 Femoral Components	Howmedica Corp.	1998	1
−4	K013106	2 Piece Modular Hip Stem	Howmedica Osteonics Corp.	2002	37
−3	K022549	Restoration Modular System	Howmedica Osteonics Corp.	2002	3
−2	K090757	Biomet Modular Femoral Revision System	Biomet, Inc.	2009	18
−1	K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…	Encore Medical L.P.	2010	1
0 (this device)	K113296	ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented…	Zimmer, Inc.	2012	—
+1	K200823	Zimmer, Inc. Hip Joint Prostheses MR Labeling I	Zimmer, Inc.	2020	1
+2	K250834	Zimmer Biomet Ceramic Heads (22.2mm diameter)	Zimmer Biomet	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	2	0
1987	2	0
1988	2	0
1990	1	0
1991	1	0
1994	6	0
1995	8	0
1996	9	0
1997	5	0
1998	2	0
1999	4	0
2000	12	0
2001	3	0
2002	3	0
2003	7	0
2004	3	0
2005	2	0
2006	3	0
2007	1	0
2008	1	0
2010	1	0
2011	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2025	1	0

FIG. 1 — Lineage of K113296, 1994–2025Source: 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 LPH? 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 LPH device

#1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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? (10)

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
*	K992667	ZMR Hip System-Revision Taper Summary page 2 …cemented or uncemented prosthesis Predicate Device: ZMR Hip System - Revision Taper, manufactured by Zimmer, Inc, K992667, cleared October 27, 1999 ZMR Hip System - Porous Revisi…	Zimmer, Inc.	1999	1
*	K994286	ZMR Hip System-Porous Revision Summary page 2 …1999 ZMR Hip System - Porous Revision, manufactured by Zimmer, Inc, K994286, cleared March 10, 2000 ZMR Hip System - XL, manufactured by Zimmer,…	Zimmer, Inc.	2000	11
*	K031572	ZMR Hip System-XL, Models 9921, 9922 and 9923 Summary page 2 …y Zimmer, Inc, K994286, cleared March 10, 2000 ZMR Hip System - XL, manufactured by Zimmer, Inc, K03 1572, cleared June 24, 2003 Taperloc Complete System and Taperloc Complete…	Zimmer, Inc.	2003	6
*	K101086	Taperloc Complete Summary page 2 …Taperloc Complete System and Taperloc Complete Microplasty System, manufactured by Biomet, Inc., K 10 1086, cleared September 3, 20 10 and KI 110400, cleared September 30, 2011…	Biomet, Inc.	2010	—
*	K110400	Taperloc Complete Microplasty Stem Summary page 2 …te Microplasty System, manufactured by Biomet, Inc., K 10 1086, cleared September 3, 20 10 and KI 110400, cleared September 30, 2011 DJO Surgical Revision Femora…	Biomet Manufacturing Corp	2011	—
*	K092331	Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110; Summary page 2 …ptember 30, 2011 DJO Surgical Revision Femoral Hip System, manufactured by Encore Medical, L.P., K09233 1, cleared March 3, 2010 Trabecular Metal Acetabular Augme…	Encore Medical L.P.	2010	1
*	K061067	Trabecular Metal Acetabular Augments Summary page 2 …Trabecular Metal Acetabular Augments, manufactured1 by Zimmer Trabecular Metal Technology, K06 1067, cleared May 25, 2006 and K04287 1, cleared December 21, 2004…	Zimmer Trabecular	2006	4
*	K042871	Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3… Summary page 2 …manufactured1 by Zimmer Trabecular Metal Technology, K06 1067, cleared May 25, 2006 and K04287 1, cleared December 21, 2004 Hedrocel Acetabular Restrictor, manufactured by…	Zimmer Trabecular	2004	—
*	K962468	Hedrocel Acetabular Restrictor Summary page 2 …04287 1, cleared December 21, 2004 Hedrocel Acetabular Restrictor, manufactured by Implex Corp., K962468, cleared February 3, 1997 Zimmer TrabecularMetal Acetabular Revision…	Implex Corp.	1997	—
*	K061226	Trabecular Metal Acetabular Revision System Cage Summary page 2 …Zimmer TrabecularMetal Acetabular Revision System Cage, manufactured by Zimmer, Inc, K061226, cleared August 2, 2006. Tc~ 24-5k K…	Zimmer, Inc.	2006	—

Also cleared against K992667: 6 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K200823	Zimmer, Inc. Hip Joint Prostheses MR Labeling I	Zimmer, Inc.	2020	1

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?

The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
26 of the 87 ancestors have a recall of any class.
Of its descendants, K200823 (Zimmer, Inc., 2020) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K992667.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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	10	116	16	509
2008	10	86	1	706
2009	3	112	2	1,156
2010	15	100	22	2,007
2011	16	110	26	3,320
2012	25	76	30	3,785
2013	11	135	9	5,002
2014	20	129	3	5,163
2015	18	111	1	5,830
2016	10	150	8	4,900
2017	12	121	14	5,312
2018	9	145	2	5,954
2019	22	164	8	7,130
2020	7	164	6	5,429
2021	8	410	4	5,978
2022	14	247	2	5,223
2023	10	111	2	5,345
2024	6	92	1	5,626
2025	12	153	4	6,163
2026	8	256	2	—

What is it indicated for?

The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113296 · printed Nov 3, 2026

Cite this page

510(k) Report. “K113296: ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113296

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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