510(k) Report

510(k) · Cleared

Cleared

U2 Hip Stem, TI Porous Coated

K003237510(k) TraditionalCleared Jan 10, 200185-day reviewClass II21 CFR 888.3358

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

United Orthopedic Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 10, 2001 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 45 later devices descend from it.

Decided
Jan 10, 2001
Review
85 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

45 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 4 descendants cleared2015: 2 descendants cleared2007: 1 descendant cleared2025: 3 descendants cleared2005: 1 descendant cleared2011: 1 descendant cleared2017: 3 descendants cleared2012: 3 descendants cleared2018: 2 descendants cleared2026: 4 descendants cleared2022: 2 descendants cleared2023: 2 descendants cleared2016: 2 descendants cleared2021: 3 descendants cleared2019: 5 descendants cleared2020: 5 descendants cleared2024: 2 descendants cleared200020052010201520202025
  1. This deviceK003237 U2 Hip Stem, TI Porous CoatedUnited Orthopedic Corp. · 2001
  2. Descendant · cites it directly · 42 of its ownK050262 U2 Acetabular ComponentUnited Orthopedic Corp. · 2005
  3. Descendant · 2 generations on · 23 of its ownK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
  4. Descendant · 2 generations on · 9 of its ownK121777 U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 2012 · Recalled
  5. Descendant · 3 generations on · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
  6. Descendant · 3 generations on · 8 of its ownK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2005: 12007: 12011: 12012: 32013: 42015: 22016: 22017: 32018: 22019: 52020: 52021: 32022: 22023: 22024: 22025: 32026: 4
2005high 5 (2019) · low 0 (2006)2026

Most influential descendants

Showing 5 of 45 · See all
  • K050262U2 Acetabular ComponentUnited Orthopedic Corp. · 2005 · cites it directly42descendants
  • K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · 2 generations on23descendants
  • K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 2012 · 2 generations on9descendants
  • K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019 · 3 generations on8descendants
  • K152893Corin Optimized Positioning System (OPS)Corin USA · 2016 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003237U2 Hip Stem, TI Porous CoatedUnited Orthopedic Corp.2001—
+1K050262U2 Acetabular ComponentUnited Orthopedic Corp.2005—
+2K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA20134
+2K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp.20121
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG2019—
+3K152893Corin Optimized Positioning System (OPS)Corin USA2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
201110
201230
201340
201520
201620
201730
201820
201950
202050
202130
202220
202320
202420
202530
202640
FIG. 1 — Lineage of K003237, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LPH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (45)

See all 45

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

NumberDeviceApplicantDecidedDescendants
K050262U2 Acetabular ComponentUnited Orthopedic Corp.200542
K062978U2 Hip Stem, TI Plasma SprayUnited Orthopedic Corp.20071
K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250
K151316U2 Hip Stem, Ti Porous Coated, MatrixUnited Orthopedic Corporation20150
K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130

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?

  • Of its descendants, K050262 (United Orthopedic Corp., 2005) has gone furthest, with 42 descendants of its own.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from United Orthopedic Corp.

20 FDA decisions under this applicant name. See the company

  • K140073U2 Femoral Component, CR, CementedUnited Orthopedic Corp. · 2014
  • K140075U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp. · 2014
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
  • K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  • K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013

Recent decisions in LPH

The LPH category page

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  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K003237 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003237: U2 Hip Stem, TI Porous Coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003237

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026