510(k) Report

510(k) · Cleared

Cleared

Profemur Z Revision Hip Stem

K122778510(k) SpecialCleared Oct 11, 201230-day reviewClass III21 CFR 888.3330

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

Wrightmedicaltechnologyinc · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Cleared on Oct 11, 2012 as substantially equivalent to K021346 (Wrightmedicaltechnologyinc, 2002) and 2 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1989. 2 of the 10 devices in its family, counting itself, have a Class I recall.

Decided
Oct 11, 2012
Review
30 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K893685 (1989). 9 ancestors in all. No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2002: 1 other ancestor2009: 1 other ancestor, 1 with a Class I recall12006: 1 other ancestor2001: 1 other ancestor2008: 1 other ancestorK893685 · Ceramic Femoral Head · Dow Corning Wright · 1989K100866 · Profemur Hip System Modular Necks · Wrightmedicaltechnologyinc · 2010 · Class I recallK112080 · Preserve Hip Stem · Wrightmedicaltechnologyinc · 2011K121221 · Profemur Z Revision Hip Stem · Wrightmedicaltechnologyinc · 2012198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors, 1 with a Class I recall13 generations back: 1 other ancestor K121221 · Profemur Z Revision Hip Stem · Wrightmedicaltechnologyinc · 2012K112080 · Preserve Hip Stem · Wrightmedicaltechnologyinc · 2011K100866 · Profemur Hip System Modular Necks · Wrightmedicaltechnologyinc · 2010 · Class I recallK893685 · Ceramic Femoral Head · Dow Corning Wright · 19890
  1. Root · 4 generations backK893685 Ceramic Femoral HeadDow Corning Wright · 1989
  2. 3 generations backK100866 Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · Recalled (Class I)
  3. 2 generations backK112080 Preserve Hip StemWrightmedicaltechnologyinc · 2011
  4. 1 generation backK121221 Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  5. This deviceK122778 Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012

Class I recalls in this family

  • K100866 Profemur Hip System Modular Necks2 generations back · 2010
  • K091423 Profemur Hip System Modular Necks2 generations back · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K893685Ceramic Femoral HeadDow Corning Wright1989—
−3K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc2010Class I
−2K112080Preserve Hip StemWrightmedicaltechnologyinc2011—
−1K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc2012—
0 (this device)K122778Profemur Z Revision Hip StemWrightmedicaltechnologyinc2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200610
200810
200911
FIG. 1 — Lineage of K122778, 1989–2012Source: 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.

2 devices in this family have 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
*K021346Stem Hip Replacement System, Model PHA002XX
Summary page 1
…Orthopedics/87/ KWA, JDL Predicate Devices: STEM Hip Replacement System 510(k)s: K021346 PRESERVE HIP STEM 510(…
Wrightmedicaltechnologyinc20023
*K112080Preserve Hip Stem
Summary page 1
…510(k)s: K021346 PRESERVE HIP STEM 510(K): K(112080 PROFEMUR Z Revision Hip Stem…
Wrightmedicaltechnologyinc2011—
*K121221Profemur Z Revision Hip Stem
Summary page 1
…510(K): K(112080 PROFEMUR Z Revision Hip Stem 510(K): K121221 DEVICE INFORMATION A. Intended Use Wright Medical total hip systems are indicated for use in total hip arthroplasty for redu…
Wrightmedicaltechnologyinc2012—

Also cleared against K021346: 10 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

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.

  • K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
  • K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
  • 4 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
  • 10 other devices also cite its predicate K021346.

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. 2012, 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?

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

Indications for use as stated in the FDA summary.

Also cleared against K021346

10 other devices cite the same predicate.

  • K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
  • K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013
  • K123434Profemur Z Classic StemsWrightmedicaltechnologyinc · 20131 recall
  • K121221Profemur Z Revision Hip StemWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011
  • K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011

More from Wrightmedicaltechnologyinc

311 FDA decisions under this applicant name. See the company

  • K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2023
  • K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc · 2022
  • K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2021
  • K202815PROPHECY Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc · 2021
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

Recent decisions in KWA

The KWA category page

  • K121544Dynasty Biofoam ShellWrightmedicaltechnologyinc · 2012
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113322Conserve Thin ShellWrightmedicaltechnologyinc · 2012
  • K112080Preserve Hip StemWrightmedicaltechnologyinc · 2011
  • K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc · 2011

https://510kreport.com/device/K122778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122778: Profemur Z Revision Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122778

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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