510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Profemur XTR Hip Stem

K052915510(k) SpecialCleared Jan 27, 2006102-day reviewClass III21 CFR 888.3330Recalls 3

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 Jan 27, 2006 after a 102-day review. The FDA summary names no predicate by number. 8 later devices descend from it. It has been recalled 3 times.

Decided
Jan 27, 2006
Review
102 days
Class
Class III
Product code
KWA
Recalls
3
Predicates
0

8 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2018: 1 descendant cleared2011: 2 descendants cleared2024: 2 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK052915 Profemur XTR Hip StemWrightmedicaltechnologyinc · 2006
  2. Descendant · cites it directly · 5 of its ownK111910 Gladiator Hip StemWrightmedicaltechnologyinc · 2011
  3. Descendant · cites it directly · 2 of its ownK130167 Profemur XM Distal CentralizerWrightmedicaltechnologyinc · 2013
  4. Descendant · 2 generations on · 1 of its ownK201519 PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc. · 2020
  5. Descendant · cites it directly · 1 of its ownK173898 MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
  6. Descendant · 2 generations on · 0 of its ownK240046 Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 22013: 12018: 12020: 12022: 12024: 2
2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all
  • K111910Gladiator Hip StemWrightmedicaltechnologyinc · 2011 · cites it directly5descendants
  • K130167Profemur XM Distal CentralizerWrightmedicaltechnologyinc · 2013 · cites it directly2descendants
  • K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc. · 2020 · 2 generations on1descendant
  • K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018 · cites it directly1descendant
  • K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052915Profemur XTR Hip StemWrightmedicaltechnologyinc2006—
+1K111910Gladiator Hip StemWrightmedicaltechnologyinc2011—
+1K130167Profemur XM Distal CentralizerWrightmedicaltechnologyinc2013—
+2K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.2020—
+1K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)2018—
+2K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
201310
201810
202010
202210
202420
FIG. 1 — Lineage of K052915, 2006–2024Source: 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?

The FDA summary names no predicate by number.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K111910Gladiator Hip StemWrightmedicaltechnologyinc20115
K130167Profemur XM Distal CentralizerWrightmedicaltechnologyinc20132
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181
K113019Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerWrightmedicaltechnologyinc20110

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

Recalls of this device

DateClassRecallRoot causeReason
Sep 5, 2012Class IIZ-0183-2013Packaging process controlThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Sep 5, 2012Class IIZ-0184-2013Packaging process controlThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Sep 5, 2012Class IIZ-0185-2013Packaging process controlThere may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K111910 (Wrightmedicaltechnologyinc, 2011) has gone furthest, with 5 descendants of its own.

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.

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 PROFEMUR® XTR Cemented Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

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;

correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed

Indications for use as stated in the FDA summary.

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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/K052915 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052915: Profemur XTR 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/K052915

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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