510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

U2 Hip System

K111546510(k) TraditionalCleared Jul 1, 201128-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 Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jul 1, 2011 as substantially equivalent to K070756 (Smith & Nephew, Inc., 2007) and 6 other predicates after a 28-day review. Its family tree reaches back 4 generations to 1986. 13 later devices descend from it. It has been recalled once.

Decided
Jul 1, 2011
Review
28 days
Class
Class II
Product code
LPH
Recalls
1
Predicates
7

Its longest line of descent runs back 4 generations to K861766 (1986). 27 ancestors in all. 13 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2000: 4 other ancestors1999: 4 other ancestors2001: 2 other ancestors1998: 1 other ancestor1997: 3 other ancestors1995: 3 other ancestors1990: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor2013: 3 descendants cleared2017: 4 descendants cleared2018: 1 descendant cleared2012: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared2019: 1 descendant cleared2026: 1 descendant clearedK861766 · Howmedica Hoffmann Fixation Pin System · Howmedica Corp. · 1986K964094 · Minifix · Ferguson Medical · 1996K061253 · Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2006K070756 · Smith and Nephew Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2007 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 13 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 6 descendants K070756 · Smith and Nephew Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2007 · recalledK061253 · Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2006K964094 · Minifix · Ferguson Medical · 1996K861766 · Howmedica Hoffmann Fixation Pin System · Howmedica Corp. · 19860
  1. Root · 4 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
  2. 3 generations backK964094 MinifixFerguson Medical · 1996
  3. 2 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
  4. 1 generation backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
  5. This deviceK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011
  6. Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  7. Descendant · 2 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
  8. Descendant · 2 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
  9. Descendant · cites it directly · 3 of its ownK122504 Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012
  10. Descendant · cites it directly · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2012: 12013: 32017: 42018: 12019: 12022: 12023: 12026: 1
2012high 4 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 13 · See all
  • K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
  • K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 2 generations on3descendants
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 2 generations on3descendants
  • K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012 · cites it directly3descendants
  • K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K861766Howmedica Hoffmann Fixation Pin SystemHowmedica Corp.1986—
−3K964094MinifixFerguson Medical1996—
−2K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006—
−1K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.20076
0 (this device)K111546U2 Hip SystemUnited Orthopedic Corp.2011—
+1K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.2013—
+2K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017—
+2K132455U-Motion II PS+ CupUnited Orthopedic Corp.2013—
+1K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation2012—
+1K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199010
199210
199410
199530
199730
199810
199940
200040
200120
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201330
201740
201810
201910
202210
202310
202610
FIG. 1 — Lineage of K111546, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (7)

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
*K070756Smith and Nephew Reflection 3 Acetabular System
Summary page 1
…Class 11 Panel Code Orthopaedics Device Device Product Code: LPI1, JDI Predicate Device: 1. "Smith & Nephew" R3 Acetabular Cup System (K070756) 2. "UNITED" Femoral Head (K022520, K994078) 3. "Osteonics" Crossfire Sys…
Smith & Nephew, Inc.20076
*K022520U2 Acetabular Cup
Summary page 1
…e Product Code: LPI1, JDI Predicate Device: 1. "Smith & Nephew" R3 Acetabular Cup System (K070756) 2. "UNITED" Femoral Head (K022520, K994078) 3. "Osteonics" Crossfire System Acetabular Insert (K993352) 4. "…
United Orthopedic Corp.2003—
*K994078U1 Hip System
Summary page 1
…Code: LPI1, JDI Predicate Device: 1. "Smith & Nephew" R3 Acetabular Cup System (K070756) 2. "UNITED" Femoral Head (K022520, K994078) 3. "Osteonics" Crossfire System Acetabular Insert (K993352) 4. "Smith & N…
United Orthopedic Corp.2000—
*K993352Crossfire System 12 Acetabular Inserts
Summary page 1
…p System (K070756) 2. "UNITED" Femoral Head (K022520, K994078) 3. "Osteonics" Crossfire System Acetabular Insert (K993352) 4. "Smith & Nephew" Synergy Hip System-Press Fit…
Howmedica Osteonics Corp.1999—
*K061066Synergy Hip System
Summary page 1
…sfire System Acetabular Insert (K993352) 4. "Smith & Nephew" Synergy Hip System-Press Fit (K06 1066) 5. "Smith & Nephew" Synergy Cemented Hip Stem…
Smith & Nephew, Inc.2006—
*K990369Synergy Cemented Hip Stem
Summary page 1
…(K06 1066) 5. "Smith & Nephew" Synergy Cemented Hip Stem (K990369) 6. "Zimmer" Intramedullary Bone Plug (K001 733) Device Description: U2 Hip System desi…
Smith & Nephew, Inc.1999—
*K001733Allen Medullary Cement Plugs, Zimmer Poly Plug Intramedullary System, Model 8011 Series…
Summary page 1
…mith & Nephew" Synergy Cemented Hip Stem (K990369) 6. "Zimmer" Intramedullary Bone Plug (K001 733) Device Description: U2 Hip System designed for hip arthroplasty is a mnetal/polymner/metal UOC-FDA…
Zimmer, Inc.20001

Also cleared against K070756: 14 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137
K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123
K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182
K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231
K162957U2 Femoral HeadUnited Orthopedic Corporation20171
K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171
K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 20, 2013Class IIZ-1382-2013Labeling 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 25 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
  • 4 of the 27 ancestors have a recall of any class.
  • Of its descendants, K122185 (United Orthopedic Corp., 2013) has gone furthest, with 7 descendants of its own.
  • 14 other devices also cite its predicate K070756.

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 in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: For use as a Total Hip Replacement 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other…

Read the full statement (126 words)

This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

For use as a Total Hip Replacement

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.

2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

For use as a Bipolar Hip Replacement

1. Femoral head/neck factures or non-unions.

2. Aseptic necrosis of the femoral head.

3. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.

Cemented stem is designed for cemented use only.

Indications for use as stated in the FDA summary.

Also cleared against K070756

14 other devices cite the same predicate.

  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K213842ONVOY Acetabular SystemGlobus Medical, Inc. · 2022
  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 20221 recall
  • K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd. · 2022
  • K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc. · 2020
  • K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc. · 2015

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

  • 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/K111546 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111546: U2 Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111546

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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