510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

United Utf Stem

K110245510(k) TraditionalCleared Aug 4, 2011189-day reviewClass II21 CFR 888.3358Recalls 1

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

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

Cleared on Aug 4, 2011 as substantially equivalent to K052792 (Smith & Nephew, Inc., 2005) and 2 other predicates after a 189-day review. Its family tree reaches back 4 generations to 1997. 7 later devices descend from it. It has been recalled once.

Decided
Aug 4, 2011
Review
189 days
Class
Class II
Product code
LPH
Recalls
1
Predicates
3

Its longest line of descent runs back 4 generations to P960047 (1997). 26 ancestors in all, the oldest K830313 (1983). 7 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1994: 6 other ancestors2003: 1 other ancestor2001: 1 other ancestor1996: 3 other ancestors1983: 1 other ancestor2000: 1 other ancestor1999: 2 other ancestors1998: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor2017: 3 descendants cleared2025: 1 descendant cleared2013: 2 descendants cleared2019: 1 descendant clearedP960047 · Osteonics Constrained Acetabular Insert · Howmedica Osteonics Corp. · 1997×2: 2 generations cleared close together, K021728 (2002), K030047 (2003) K043537 · Taperloc 12/14 Taper Femoral Components · Biomet, Inc. · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 5 other ancestors4 generations back: 11 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants K043537 · Taperloc 12/14 Taper Femoral Components · Biomet, Inc. · 2005K030047 · Freedom Constrained Liners · Biomet, Inc. · 2003K021728 · Ringloc Constrained Liners II · Biomet, Inc. · 2002P960047 · Osteonics Constrained Acetabular Insert · Howmedica Osteonics Corp. · 19970
  1. Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
  2. 3 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
  3. 2 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
  4. 1 generation backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
  5. This deviceK110245 United Utf StemUnited Orthopedic Corporation · 2011
  6. Descendant · cites it directly · 4 of its ownK123550 Utf Stem, ReducedUnited Orthopedic Corporation · 2013
  7. Descendant · 2 generations on · 3 of its ownK132207 Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation · 2013
  8. Descendant · cites it directly · 2 of its ownK163193 UTF Stem, reduced, #0, #00United Orthopedic Corporation · 2017
  9. Descendant · cites it directly · 1 of its ownK172251 UTS StemUnited Orthopedic Corporation · 2017
  10. Descendant · cites it directly · 1 of its ownK163585 Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 22017: 32019: 12025: 1
2013high 3 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K123550Utf Stem, ReducedUnited Orthopedic Corporation · 2013 · cites it directly4descendants
  • K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation · 2013 · 2 generations on3descendants
  • K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation · 2017 · cites it directly2descendants
  • K172251UTS StemUnited Orthopedic Corporation · 2017 · cites it directly1descendant
  • K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC · 2017 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4P960047Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp.1997—
−3K021728Ringloc Constrained Liners IIBiomet, Inc.2002—
−2K030047Freedom Constrained LinersBiomet, Inc.2003—
−1K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc.2005—
0 (this device)K110245United Utf StemUnited Orthopedic Corporation2011—
+1K123550Utf Stem, ReducedUnited Orthopedic Corporation2013—
+2K132207Utf Stem-Reduced, Additional SizesUnited Orthopedic Corporation2013—
+1K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation2017—
+1K172251UTS StemUnited Orthopedic Corporation2017—
+1K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198610
199460
199510
199630
199720
199810
199920
200010
200110
200310
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201320
201730
201910
202510
FIG. 1 — Lineage of K110245, 1997–2025Source: 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 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 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K052792Anthology Hip Stem
Summary page 1
…Orthopaedics Device Device Product Code LPH, KWY, LZO Predicate Device: 1. Smith & Nephew ANTHOLOGY Primary hip system (K052792) 2. BIOMETTAPERLOC Hip System (K921301, K043537) Device Description: UTE Stem is a modular, we…
Smith & Nephew, Inc.20051
*K921301Taperloc Femoral Stem and Universal Acetabular Com
Summary page 1
…Predicate Device: 1. Smith & Nephew ANTHOLOGY Primary hip system (K052792) 2. BIOMETTAPERLOC Hip System (K921301, K043537) Device Description: UTE Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forg…
Biomet, Inc.1994—
*K043537Taperloc 12/14 Taper Femoral Components
Summary page 1
…e Device: 1. Smith & Nephew ANTHOLOGY Primary hip system (K052792) 2. BIOMETTAPERLOC Hip System (K921301, K043537) Device Description: UTE Stem is a modular, wedge-shaped stem with 12/14 neck taper, which is made from forging Ti-6A…
Biomet, Inc.2005—

Also cleared against K052792: 18 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K123550Utf Stem, ReducedUnited Orthopedic Corporation20134
K163193UTF Stem, reduced, #0, #00United Orthopedic Corporation20172
K172251UTS StemUnited Orthopedic Corporation20171
K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171
K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 20, 2013Class IIZ-1385-2013Labeling designThe recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
  • 3 of the 26 ancestors have a recall of any class.
  • Of its descendants, K123550 (United Orthopedic Corporation, 2013) has gone furthest, with 4 descendants of its own.
  • 18 other devices also cite its predicate K052792.

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. 2011, this device’s year, is highlighted.

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—

What is it indicated for?

This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions: non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia; inflammatory degenerative joint disease such as rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; revision procedures where other treatments or devices have failed.

UTF Stem is designed for cementless use.

Indications for use as stated in the FDA summary.

Also cleared against K052792

18 other devices cite the same predicate.

  • K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024
  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 20221 recall
  • K173267MasterLoc Stem: Lateralized PlusMedacta International S.A. · 2017
  • K172684Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip StemSmith & Nephew, Inc. · 2017

More from United Orthopedic Corporation

41 FDA decisions under this applicant name. See the company

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation · 2025
  • K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation · 2025
  • K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation · 2025
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • 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/K110245 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110245: United Utf Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110245

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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