510(k) Report

510(k) · Cleared

Cleared

Uni Hip Stem

K024134510(k) SpecialCleared Jan 15, 200330-day reviewClass II21 CFR 888.3360

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

Plus Orthopedics · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jan 15, 2003 as substantially equivalent to K001942 (Plus Orthopedics, 2000) after a 30-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.

Decided
Jan 15, 2003
Review
30 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K932481 (1994). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant clearedK932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 20001990200020102020
Descendants, by generation 1 generation forward: 1 descendant K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 19940
  1. Root · 2 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
  2. 1 generation backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
  3. This deviceK024134 Uni Hip StemPlus Orthopedics · 2003
  4. Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K932481SL-Plus and SLR-PlusEncore Orthopedics, Inc.1994—
−1K001942SL-Plus and SLR-Plus StemsPlus Orthopedics2000—
0 (this device)K024134Uni Hip StemPlus Orthopedics2003—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20132

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K024134, 1994–2013Source: 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 LWJ? 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? (1)

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
*K001942SL-Plus and SLR-Plus StemsPlus Orthopedics2000—

Also cleared against K001942: 8 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20130

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?

  • The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K123598 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K001942.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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
20072—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

What is it indicated for?

The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Indications for use as stated in the FDA summary.

Also cleared against K001942

8 other devices cite the same predicate.

  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 20132 recalls
  • K093991SLR-Plus Standard and Lateral Femoral StemsSmith & Nephew, Inc. · 2010
  • K072852SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
  • K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A. · 20081 recall
  • K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc. · 20061 recall
  • K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc. · 2005

More from Plus Orthopedics

38 FDA decisions under this applicant name. See the company

  • K032126Promos ShoulderPlus Orthopedics · 2004
  • K033763Modification to Slim Gliding Nail SystemPlus Orthopedics · 2003
  • K032709Modular Plus Hip StemPlus Orthopedics · 2003
  • K032548IP-XS Compression Nail SystemPlus Orthopedics · 2003
  • K032215VKS/TC-Plus Revision KneePlus Orthopedics · 2003

Recent decisions in LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007

https://510kreport.com/device/K024134 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024134: Uni Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024134

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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