510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology

K063251510(k) TraditionalCleared Jan 24, 200789-day reviewClass III21 CFR 888.3330Recalls 4

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

Zimmer, Inc. · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Jan 24, 2007 as substantially equivalent to K032726 (Zimmer, Inc., 2003) and 2 other predicates after an 89-day review. Its family tree reaches back 6 generations to 1985. 1 of the 23 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 4 times.

Decided
Jan 24, 2007
Review
89 days
Class
Class III
Product code
KWA
Recalls
4
Predicates
3

Its longest line of descent runs back 6 generations to K850055 (1985). 17 ancestors in all. 5 later devices descend from it, 4 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor1997: 1 other ancestor1994: 5 other ancestors1990: 1 other ancestor1996: 1 other ancestor1987: 1 other ancestor2011: 1 descendant cleared2019: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared, 1 with a Class I recall12020: 1 descendant clearedK850055 · Profile Femoral Hip · Depuy, Inc. · 1985K961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalled×2: 2 generations cleared close together, K992667 (1999), K994286 (2000) K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK042337 · Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 5 other ancestors4 generations back: 2 other ancestors 1 generation forward: 4 descendants, 1 with a Class I recall12 generations forward: 1 descendant K042337 · Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 2004K032726 · Zimmer M/L Taper Hip Prosthesis, 7711 Series · Zimmer, Inc. · 2003 · recalledK994286 · ZMR Hip System-Porous Revision · Zimmer, Inc. · 2000 · recalledK992667 · ZMR Hip System-Revision Taper · Zimmer, Inc. · 1999 · recalledK961378 · Delta Hip Prosthesis · Zimmer, Inc. · 1996 · recalledK850055 · Profile Femoral Hip · Depuy, Inc. · 1985−50
  1. Root · 6 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
  2. 5 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
  3. 4 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
  4. 3 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
  5. 2 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
  6. 1 generation backK042337 Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004
  7. This deviceK063251 Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc. · 2007
  8. Descendant · cites it directly · 3 of its ownK081007 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc. · 2008
  9. Descendant · cites it directly · 3 of its ownK071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System…Zimmer, Inc. · 2007 · Recalled (Class I)
  10. Descendant · cites it directly · 1 of its ownK182678 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc. · 2019
  11. Descendant · 2 generations on · 0 of its ownK200959 Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR…Biomet UK, Ltd. · 2020
  12. Descendant · cites it directly · 0 of its ownK110836 CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH · 2011 · Recalled

Class I recalls in this family

  • K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…cites it directly · 2007

Most influential descendants

Showing 5 of 5 · See all
  • K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc. · 2008 · cites it directly3descendants
  • K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc. · 2007 · cites it directly3descendants
  • K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc. · 2019 · cites it directly1descendant
  • K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd. · 2020 · 2 generations on0descendants
  • K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K850055Profile Femoral HipDepuy, Inc.1985—
−5K961378Delta Hip ProsthesisZimmer, Inc.19964
−4K992667ZMR Hip System-Revision TaperZimmer, Inc.19991
−3K994286ZMR Hip System-Porous RevisionZimmer, Inc.200011
−2K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.20033
−1K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.2004—
0 (this device)K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.2007—
+1K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.2008—
+1K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S)…Zimmer, Inc.2007Class I
+1K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.2019—
+2K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.2020—
+1K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH20111

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199450
199610
199710
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200711
200810
201110
201910
202010
FIG. 1 — Lineage of K063251, 1985–2020Source: 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.

1 device in this family has a Class I recall. 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? (3)

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
*K032726Zimmer M/L Taper Hip Prosthesis, 7711 Series
Summary page 1
…sphate, 21 CFR § 888. 3353 Predicate Device: Zimmer® M/L Taper Hip Prosthesis, manufactured by Zimmer, Inc., K032726, cleared October 22, 2003 Profemur TL Hip Stem manuf…
Zimmer, Inc.20033
*K060358Profemur TL Hip Stem
Summary page 2
…2003 Profemur TL Hip Stem manufactured by Wright Medical Technology, Inc., K060358, cleared May 10, 2006 Zimmer®M/L Taper Hip Prosthesis with Calcicoat®…
Wrightmedicaltechnologyinc2006—
*K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic Coating
Summary page 2
…10, 2006 Zimmer®M/L Taper Hip Prosthesis with Calcicoat® Ceramic Coating, manufactured by Zimmer, Inc., K042337, cleared November 4, 2004 Device Description: The Zimmer M/L Taper Hip Prosthesis with Modular Neck Tech…
Zimmer, Inc.2004—

Also cleared against K032726: 6 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083
K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (… Class IZimmer, Inc.20073
K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191
K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH20110

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 30, 2018Class IIZ-2364-2018PackagingM/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant.…
May 30, 2018Class IIZ-2365-2018Packaging
May 30, 2018Class IIZ-2375-2018PackagingM/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant.…
May 29, 2009Not classifiedZ-1617-2009Packaging process controlThe corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
  • 7 of the 17 ancestors have a recall of any class.
  • Of its descendants, K081007 (Zimmer, Inc., 2008) has gone furthest, with 3 descendants of its own.
  • 6 other devices also cite its predicate K032726.

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. 2007, 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?

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected…

Read the full statement (141 words)

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.

This femoral stem is for cementless use only.

Indications for use as stated in the FDA summary.

Also cleared against K032726

6 other devices cite the same predicate.

  • K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2020
  • K163577Ecofit® Hip SystemImplantcast GmbH · 20171 recall
  • K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 2016
  • K071723Zimmer Porolock Mis StemZimmer GmbH · 20082 recalls
  • K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc. · 20062 recalls
  • K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 2004

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

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/K063251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063251: Zimmer M/L Taper Hip Prosthesis with Modular Neck Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063251

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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