510(k) Report

510(k) · Cleared

Cleared

Profemur XM Wingless Distal Centralizer, Perfecta Distal Centralizer

K113019510(k) SpecialCleared Nov 10, 201130-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 Nov 10, 2011 as substantially equivalent to K052915 (Wrightmedicaltechnologyinc, 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1991.

Decided
Nov 10, 2011
Review
30 days
Class
Class III
Product code
KWA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K911052 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK911052 · Nexus (TM) Femoral Hip Stem · Dow Corning Wright · 199119901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor K911052 · Nexus (TM) Femoral Hip Stem · Dow Corning Wright · 19910
  1. Root · 1 generation backK911052 Nexus (TM) Femoral Hip StemDow Corning Wright · 1991
  2. This deviceK113019 Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerWrightmedicaltechnologyinc · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911052Nexus (TM) Femoral Hip StemDow Corning Wright1991—
0 (this device)K113019Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerWrightmedicaltechnologyinc2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K113019, 1991–2011Source: 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
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What was it cleared against? (2)

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
*K052915Profemur XTR Hip Stem
Summary page 1
…ROFEMURO XM (PROFEMVUR XTR) NEXUS M Femoral Hip Stem 510(k): K052915, K911052 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Descr…
Wrightmedicaltechnologyinc20063
*K911052Nexus (TM) Femoral Hip Stem
Summary page 1
…XM (PROFEMVUR XTR) NEXUS M Femoral Hip Stem 510(k): K052915, K911052 Predicate Classification and Number: Orthopedics/87/ KWA, 888.3330 DEVICE INFORMATION A. Device Descr iption…
Dow Corning Wright1991—

Also cleared against K052915: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 1 of the 2 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K052915.

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. 2011, 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 PMMA Distal Centralizers are intended 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;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed

The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

Indications for use as stated in the FDA summary.

Also cleared against K052915

3 other devices cite the same predicate.

  • K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo) · 2018
  • K130167Profemur XM Distal CentralizerWrightmedicaltechnologyinc · 2013
  • K111910Gladiator 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

  • 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/K113019 · printed Nov 3, 2026

Cite this page

510(k) Report. “K113019: Profemur XM Wingless Distal Centralizer, Perfecta Distal Centralizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113019

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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