510(k) Report

510(k) · Cleared

Cleared

U-Motion II Acetabular System

K122185510(k) TraditionalCleared Feb 22, 2013214-day reviewClass II21 CFR 888.3353

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

United Orthopedic Corp. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Feb 22, 2013 as substantially equivalent to K050262 (United Orthopedic Corp., 2005) and 15 other predicates after a 214-day review. Its family tree reaches back 10 generations to 1996. 7 later devices descend from it.

Decided
Feb 22, 2013
Review
214 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
16

Its longest line of descent runs back 10 generations to K955033 (1996). 189 ancestors in all, the oldest K810258 (1981). 7 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 4 other ancestors2010: 5 other ancestors2009: 3 other ancestors2007: 3 other ancestors2006: 7 other ancestors2005: 10 other ancestors2008: 2 other ancestors2004: 3 other ancestors2003: 9 other ancestors2002: 7 other ancestors2001: 10 other ancestors2000: 17 other ancestors1999: 8 other ancestors1998: 9 other ancestors1996: 13 other ancestors1994: 18 other ancestors1992: 6 other ancestors1997: 10 other ancestors1995: 16 other ancestors1991: 4 other ancestors1990: 2 other ancestors1988: 1 other ancestor1986: 1 other ancestor1993: 3 other ancestors1984: 1 other ancestor1987: 2 other ancestors1985: 2 other ancestors1981: 1 other ancestor2017: 2 descendants cleared2022: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996K983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002×2: 2 generations cleared close together, K040191 (2004), K043079 (2004) K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006K080584 · Metha Short Stem Hip System · Aesculap Implant System, Inc. · 2008K083312 · Minihip Stem · Corin USA · 2010K103518 · Trinity Acetabular System · Corin USA · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 15 other ancestors2 generations back: 35 other ancestors3 generations back: 40 other ancestors4 generations back: 20 other ancestors5 generations back: 32 other ancestors6 generations back: 22 other ancestors7 generations back: 12 other ancestors8 generations back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 1 descendant K103518 · Trinity Acetabular System · Corin USA · 2011K083312 · Minihip Stem · Corin USA · 2010K080584 · Metha Short Stem Hip System · Aesculap Implant System, Inc. · 2008K060437 · Excia Total Hip System with U-Cap · Aesculap, Inc. · 2006K043079 · Bicontact Hip System with U-Cap · Aesculap · 2004K040191 · Bicontact Hip Stem and Femoral Head · Aesculap · 2004K022902 · Smith & Nephew Hip System · Smith & Nephew, Inc. · 2002K993259 · Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads · Sulzer Orthopedics, Inc. · 2000 · recalledK983509 · Inter-OP Acetabular System - Durasul Acetabular Insert · Sulzer Orthopedics, Inc. · 1999K955033 · Rim Flare Acetabular Component · Intermedics Orthopedics · 1996−10−50
  1. Root · 10 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 6 generations between
  3. 3 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  4. 2 generations backK083312 Minihip StemCorin USA · 2010
  5. 1 generation backK103518 Trinity Acetabular SystemCorin USA · 2011
  6. This deviceK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
  7. Descendant · cites it directly · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
  8. Descendant · cites it directly · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
  9. Descendant · cites it directly · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
  10. Descendant · cites it directly · 2 of its ownK170089 U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017
  11. Descendant · cites it directly · 1 of its ownK221149 U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023
Show all 10 generations
  1. Root · 10 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
  2. 9 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
  3. 8 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
  4. 7 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
  5. 6 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
  6. 5 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
  7. 4 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
  8. 3 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
  9. 2 generations backK083312 Minihip StemCorin USA · 2010
  10. 1 generation backK103518 Trinity Acetabular SystemCorin USA · 2011
  11. This deviceK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12017: 22018: 12022: 12023: 12026: 1
2013high 2 (2017) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · cites it directly3descendants
  • K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · cites it directly3descendants
  • K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · cites it directly2descendants
  • K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017 · cites it directly2descendants
  • K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K955033Rim Flare Acetabular ComponentIntermedics Orthopedics1996—
−9K983509Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc.1999—
−8K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc.20003
−7K022902Smith & Nephew Hip SystemSmith & Nephew, Inc.2002—
−6K040191Bicontact Hip Stem and Femoral HeadAesculap2004—
−5K043079Bicontact Hip System with U-CapAesculap2004—
−4K060437Excia Total Hip System with U-CapAesculap, Inc.2006—
−3K080584Metha Short Stem Hip SystemAesculap Implant System, Inc.2008—
−2K083312Minihip StemCorin USA2010—
−1K103518Trinity Acetabular SystemCorin USA2011—
0 (this device)K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.2013—
+1K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation2017—
+1K132455U-Motion II PS+ CupUnited Orthopedic Corp.2013—
+1K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation2018—
+1K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation2017—
+1K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
198520
198610
198720
198810
199020
199140
199260
199330
1994180
1995160
1996130
1997100
199890
199980
2000170
2001100
200270
200390
200430
2005100
200670
200730
200820
200930
201050
201140
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201720
201810
202210
202310
202610
FIG. 1 — Lineage of K122185, 1996–2026Source: 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), 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 LZO? 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 LZO device

  1. #1 K192827 Quadra-Pscore 19.3 · 10 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? (16)

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
*K050262U2 Acetabular Component
Summary page 1
…Class 11 Panel Code Orthopaedlics Device Device Product Code: LZO, LWJ, KWY, MEH Predicate Device: I1. 'UNITED' U2 Acetabular Component (K050262) 2. "UNITED' U2 Acetabular Cup, Plasma Spray (K1 21777) 3. "UNITED" U2 Hip System…
United Orthopedic Corp.2005—
*K121777U2 Acetabular Cup, Plasma Spray
Summary page 1
…t Code: LZO, LWJ, KWY, MEH Predicate Device: I1. 'UNITED' U2 Acetabular Component (K050262) 2. "UNITED' U2 Acetabular Cup, Plasma Spray (K1 21777) 3. "UNITED" U2 Hip System (K 111546) 4. "UNITED" Ceramic Femoral Head - Delta (K…
United Orthopedic Corp.20121
*K111546U2 Hip System
Summary page 1
…ITED' U2 Acetabular Component (K050262) 2. "UNITED' U2 Acetabular Cup, Plasma Spray (K1 21777) 3. "UNITED" U2 Hip System (K 111546) 4. "UNITED" Ceramic Femoral Head - Delta (K103497, K1 12463)…
United Orthopedic Corp.20111
*K103497Ceramic Femoral Head
Summary page 1
…U2 Acetabular Cup, Plasma Spray (K1 21777) 3. "UNITED" U2 Hip System (K 111546) 4. "UNITED" Ceramic Femoral Head - Delta (K103497, K1 12463) 5. "Corin U.S.A' Trinity Acetabular System (K093472,…
United Orthopedic Corp.2011—
*K112463United 36MM Ceramic Femoral Head, Delta
Summary page 1
…21777) 3. "UNITED" U2 Hip System (K 111546) 4. "UNITED" Ceramic Femoral Head - Delta (K103497, K1 12463) 5. "Corin U.S.A' Trinity Acetabular System (K093472, K10351 8)…
United Orthopedic Corporation20111
*K093472Trinity Acetabular System
Summary page 1
…4. "UNITED" Ceramic Femoral Head - Delta (K103497, K1 12463) 5. "Corin U.S.A' Trinity Acetabular System (K093472, K10351 8) 6. "Smith & Nephew" R3 Acetabular System (K061253,…
Corin USA20101
*K103518Trinity Acetabular System
Summary page 1
…moral Head - Delta (K103497, K1 12463) 5. "Corin U.S.A' Trinity Acetabular System (K093472, K10351 8) 6. "Smith & Nephew" R3 Acetabular System (K061253, K070756, K092386…
Corin USA2011—
*K061253Reflection 3 Acetabular System
Summary page 1
…5. "Corin U.S.A' Trinity Acetabular System (K093472, K10351 8) 6. "Smith & Nephew" R3 Acetabular System (K061253, K070756, K092386 7. "Smith & Nephew" BIOLOX® Delta Ceramic Femoral…
Smith & Nephew, Inc.2006—
*K070756Smith and Nephew Reflection 3 Acetabular System
Summary page 1
…ty Acetabular System (K093472, K10351 8) 6. "Smith & Nephew" R3 Acetabular System (K061253, K070756, K092386 7. "Smith & Nephew" BIOLOX® Delta Ceramic Femoral Heads (K083762, K10…
Smith & Nephew, Inc.20076
*K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners
Summary page 1
…ular System (K093472, K10351 8) 6. "Smith & Nephew" R3 Acetabular System (K061253, K070756, K092386 7. "Smith & Nephew" BIOLOX® Delta Ceramic Femoral Heads (K083762, K1004 12) U…
Smith & Nephew, Inc.2009—
*K083762Biolox Delta Ceramic Femoral Heads
Summary page 1
…System (K061253, K070756, K092386 7. "Smith & Nephew" BIOLOX® Delta Ceramic Femoral Heads (K083762, K1004 12) UOC-FDA -021 Page: Summary-I/7 U-Motion 1…
Smith & Nephew, Inc.2009—
*K100412Biolox Delta Ceramic Femoral Heads
Summary page 1
…K061253, K070756, K092386 7. "Smith & Nephew" BIOLOX® Delta Ceramic Femoral Heads (K083762, K1004 12) UOC-FDA -021 Page: Summary-I/7 U-Motion 11 Acetabul…
Smith & Nephew, Inc.2010—
*K093846Longevity IT Highly Crosslinked Polyethylene Elevated Liners
Summary page 2
…5 10(k) Summary 8. "Zimmer" Longevity® IT Highly Crosslinked Elevated Liners (K093846, K10l229, K103662) 9. "Zimmer" Continuum Acetabular System-Bone Screw (K…
Zimmer, Inc.2010—
*K101229Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular…
Summary page 5
…Longevity® IT K093846 02/04/20 10 Highly Crosslinked Zimmer, INC. K101229 12/03/2010 Elevated Liners K103662 04/15/2011…
Zimmer, Inc.2010—
*K103662Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…
Summary page 2
…5 10(k) Summary 8. "Zimmer" Longevity® IT Highly Crosslinked Elevated Liners (K093846, K10l229, K103662) 9. "Zimmer" Continuum Acetabular System-Bone Screw (K09 1508) Device…
Zimmer, Inc.2011—
*K091508Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System
Summary page 2
…Liners (K093846, K10l229, K103662) 9. "Zimmer" Continuum Acetabular System-Bone Screw (K09 1508) Device Description: The subject device designed for total hip arthroplasty includes acetabular components and femoral componen…
Zimmer, Inc.20093

Also cleared against K050262: 8 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173
K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133
K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182
K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172
K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231
K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220

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 17 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
  • 48 of the 188 ancestors have a recall of any class.
  • Of its descendants, K163441 (United Orthopedic Corporation, 2017) has gone furthest, with 3 descendants of its own.
  • 8 other devices also cite its predicate K050262.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

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

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 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…

Read the full statement (107 words)

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

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.

4. Correction of functional deformity.

5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.

The device is intended for cementless use.

Indications for use as stated in the FDA summary.

Also cleared against K050262

8 other devices cite the same predicate.

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation · 2025
  • K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
  • K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC · 2017
  • K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013
  • K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 20134 recalls

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
  • K122183Augment and Screw, Psa TypeUnited Orthopedic Corp. · 2013
  • K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 20121 recall

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K122185 · printed Nov 4, 2026

Cite this page

510(k) Report. “K122185: U-Motion II Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122185

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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