510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;

K092331510(k) TraditionalCleared Mar 3, 2010211-day reviewClass III21 CFR 888.3330Recalls 1

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

Encore Medical L.P. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Mar 3, 2010 as substantially equivalent to K992667 (Zimmer, Inc., 1999) and 5 other predicates after a 211-day review. Its family tree reaches back 6 generations to 1994. 27 later devices descend from it. It has been recalled once.

Decided
Mar 3, 2010
Review
211 days
Class
Class III
Product code
KWA
Recalls
1
Predicates
6

Its longest line of descent runs back 6 generations to K921308 (1994). 37 ancestors in all, the oldest K850055 (1985). 27 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 4 other ancestors2000: 6 other ancestors1999: 2 other ancestors2005: 1 other ancestor1996: 5 other ancestors1994: 3 other ancestors2002: 1 other ancestor1997: 1 other ancestor1995: 5 other ancestors1990: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2012: 2 descendants cleared2015: 3 descendants cleared2016: 3 descendants cleared2025: 2 descendants cleared2014: 2 descendants cleared2019: 1 descendant cleared2020: 2 descendants cleared2017: 4 descendants cleared2023: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants cleared2026: 2 descendants cleared2024: 1 descendant clearedK921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK022549 · Restoration Modular System · Howmedica Osteonics Corp. · 2002 · recalledK090757 · Biomet Modular Femoral Revision System · Biomet, Inc. · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors3 generations back: 11 other ancestors4 generations back: 8 other ancestors 1 generation forward: 4 descendants2 generations forward: 11 descendants3 generations forward: 9 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K090757 · Biomet Modular Femoral Revision System · Biomet, Inc. · 2009 · recalledK022549 · Restoration Modular System · Howmedica Osteonics Corp. · 2002 · recalledK013106 · 2 Piece Modular Hip Stem · Howmedica Osteonics Corp. · 2002 · recalledK983404 · Type 3 Femoral Components · Howmedica Corp. · 1998 · recalledK972893 · Partnership Revision Femoral Stems · Howmedica Corp. · 1997K921308 · HG Multilock Hip Prosthesis W/ TI-Nidium · Zimmer, Inc. · 1994 · recalled−50+5
  1. Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
  2. 5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
  3. 4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
  4. 3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
  5. 2 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
  6. 1 generation backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
  7. This deviceK092331 Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P. · 2010
  8. Descendant · cites it directly · 13 of its ownK112158 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups…Lima Corporate S.P.A. · 2012
  9. Descendant · cites it directly · 7 of its ownK151739 Revision Femoral StemLima Corporate S.P.A. · 2015
  10. Descendant · 2 generations on · 5 of its ownK170690 M-Vizion Femoral Revision SystemMedacta International S.A. · 2017
  11. Descendant · 2 generations on · 5 of its ownK141327 Minima S SystemLima Corporate S.P.A. · 2014
  12. Descendant · 2 generations on · 4 of its ownK191816 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2012: 22014: 22015: 32016: 32017: 42019: 12020: 22021: 22022: 22023: 12024: 12025: 22026: 2
2012high 4 (2017) · low 0 (2013)2026

Most influential descendants

Showing 5 of 27 · See all
  • K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A. · 2012 · cites it directly13descendants
  • K151739Revision Femoral StemLima Corporate S.P.A. · 2015 · cites it directly7descendants
  • K170690M-Vizion Femoral Revision SystemMedacta International S.A. · 2017 · 2 generations on5descendants
  • K141327Minima S SystemLima Corporate S.P.A. · 2014 · 2 generations on5descendants
  • K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2020 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K921308HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc.19941
−5K972893Partnership Revision Femoral StemsHowmedica Corp.1997—
−4K983404Type 3 Femoral ComponentsHowmedica Corp.19981
−3K0131062 Piece Modular Hip StemHowmedica Osteonics Corp.200237
−2K022549Restoration Modular SystemHowmedica Osteonics Corp.20023
−1K090757Biomet Modular Femoral Revision SystemBiomet, Inc.200918
0 (this device)K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200…Encore Medical L.P.2010—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock…Lima Corporate S.P.A.2012—
+1K151739Revision Femoral StemLima Corporate S.P.A.2015—
+2K170690M-Vizion Femoral Revision SystemMedacta International S.A.2017—
+2K141327Minima S SystemLima Corporate S.P.A.2014—
+2K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
199010
199430
199550
199650
199710
199920
200060
200210
200340
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201420
201530
201630
201740
201910
202020
202120
202220
202310
202410
202520
202620
FIG. 1 — Lineage of K092331, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K992667ZMR Hip System-Revision Taper
Summary page 1
…is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants. Predicate Devices: ZMRIm Hip System - Revision Taper - Zimmner - K992667, K(031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System -…
Zimmer, Inc.19991
*K031572ZMR Hip System-XL, Models 9921, 9922 and 9923
Summary page 1
…d for cementless revision hip arthroplasty on both uncemented and cemented femoral implants. Predicate Devices: ZMRIm Hip System - Revision Taper - Zimmner - K992667, K(031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System - Plus Ortho…
Zimmer, Inc.20036
*K994038Modular Reach Hip
Summary page 1
…plasty on both uncemented and cemented femoral implants. Predicate Devices: ZMRIm Hip System - Revision Taper - Zimmner - K992667, K(031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System - Plus Orthopedics - K994 126, K032709 Comparabl…
Biomet, Inc.1999—
*K090757Biomet Modular Femoral Revision System
Cleared while this submission was under review
Summary page 1
…ants. Predicate Devices: ZMRIm Hip System - Revision Taper - Zimmner - K992667, K(031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System - Plus Orthopedics - K994 126, K032709 Comparable Features to Predicate Device(s): Features compara…
Biomet, Inc.200918
*K994126Modular-Plus Revision Stem
Summary page 1
…r - Zimmner - K992667, K(031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System - Plus Orthopedics - K994 126, K032709 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, and in…
Plus Orthopedics2000—
*K032709Modular Plus Hip Stem
Summary page 1
…r - K992667, K(031572 Modular REACH Hip - Biomet - K994038 Modular Femoral Revision System - Biomet - K090757 Modular-Plus Revision System - Plus Orthopedics - K994 126, K032709 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, and indications…
Plus Orthopedics2003—

Also cleared against K992667: 6 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213
K151739Revision Femoral StemLima Corporate S.P.A.20157
K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122
K161610EXPRT Revision Hip SystemEncore Medical L.P.20161

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 10, 2017Class IIZ-1191-2017Nonconforming Material/ComponentLima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
  • 17 of the 37 ancestors have a recall of any class.
  • Of its descendants, K112158 (Lima Corporate S.P.A., 2012) has gone furthest, with 13 descendants of its own.
  • 6 other devices also cite its predicate K992667.

How does its category compare?

All KWA devices

KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · KWA

4in 2012

2007: 82008: 92009: 72010: 62011: 112012: 4
2007high 11 (2011) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWA

76in 2012

2007: 74 days median2008: 57 days median2009: 139 days median2010: 167 days median2011: 101 days median2012: 76 days median
2007high 167 (2010) · low 57 (2008)2026

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

Recalls per year · KWA

19in 2023

2008: 132010: 842011: 282012: 212013: 12016: 12017: 12018: 12019: 22020: 12023: 19
2007high 84 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWA

1,216in 2025

2007: 2132008: 7622009: 8202010: 3,3482011: 17,7372012: 24,6012013: 20,0202014: 16,4942015: 12,3392016: 7,8722017: 6,8472018: 6,3882019: 7,6282020: 4,5382021: 2,0642022: 1,6172023: 1,4742024: 1,1682025: 1,216
2007high 24,601 (2012) · low 213 (2007)2025

MAUDE reports naming product code KWA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20078740213
200895713762
200971390820
20106167843,348
2011111012817,737
20124762124,601
20130—120,020
20140—016,494
20150—012,339
20160—17,872
20170—16,847
20180—16,388
20190—27,628
20200—14,538
20210—02,064
20220—01,617
20230—191,474
20240—01,168
20250—01,216
20260—0—

What is it indicated for?

The Modular Revision Femoral Hip Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

Indications for use as stated in the FDA summary.

Also cleared against K992667

6 other devices cite the same predicate.

  • K151739Revision Femoral StemLima Corporate S.P.A. · 2015
  • K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc. · 2012
  • K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC · 2010
  • K033893Spectrum Modular SystemDePuy Orthopaedics, Inc. · 2004
  • K031572ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc. · 20036 recalls
  • K994286ZMR Hip System-Porous RevisionZimmer, Inc. · 200011 recalls

More from Encore Medical L.P.

82 FDA decisions under this applicant name. See the company

  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026
  • K252974EMPOWR KneeEncore Medical L.P. · 2025
  • K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
  • K252141AltiVate Reverse® GlenoidEncore Medical L.P. · 2025

Recent decisions in KWA

The KWA category page

  • K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K092331 · printed Nov 5, 2026

Cite this page

510(k) Report. “K092331: Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092331

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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