510(k) Report

510(k) · Cleared

Cleared

Momentum Acetabular Cup System

K253948510(k) TraditionalCleared Sep 2, 2026266-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 Corporation · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Sep 2, 2026 as substantially equivalent to K170359 (Corin U.S.A. Limited, 2017) and 11 other predicates after a 266-day review. Its family tree reaches back 14 generations to 1981.

Decided
Sep 2, 2026
Review
266 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
12

Its longest line of descent runs back 14 generations to K810258 (1981). 346 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2023: 1 other ancestor2022: 2 other ancestors2019: 3 other ancestors2015: 3 other ancestors2014: 2 other ancestors2013: 4 other ancestors2012: 6 other ancestors2005: 15 other ancestors1998: 15 other ancestors2018: 1 other ancestor2017: 3 other ancestors2016: 2 other ancestors2011: 9 other ancestors2010: 11 other ancestors2009: 10 other ancestors2007: 12 other ancestors2004: 11 other ancestors2003: 15 other ancestors2001: 15 other ancestors2000: 27 other ancestors1999: 16 other ancestors1994: 26 other ancestors1991: 6 other ancestors2006: 12 other ancestors2002: 14 other ancestors1996: 20 other ancestors1995: 19 other ancestors1987: 3 other ancestors1983: 1 other ancestor2008: 5 other ancestors1997: 15 other ancestors1992: 7 other ancestors1990: 4 other ancestors1993: 6 other ancestors1988: 2 other ancestors1986: 3 other ancestors1985: 4 other ancestors1984: 1 other ancestorK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalled×2: 2 generations cleared close together, K042051 (2005), K051411 (2005) K061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010×2: 2 generations cleared close together, K103120 (2011), K110087 (2011) ×2: 2 generations cleared close together, K130343 (2013), K131647 (2013) K170359 · Trinity™ Dual Mobility System · Corin U.S.A. Limited · 2017 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 11 other ancestors2 generations back: 39 other ancestors3 generations back: 62 other ancestors4 generations back: 62 other ancestors5 generations back: 68 other ancestors6 generations back: 36 other ancestors7 generations back: 22 other ancestors8 generations back: 17 other ancestors9 generations back: 12 other ancestors10 generations back: 2 other ancestors K170359 · Trinity™ Dual Mobility System · Corin U.S.A. Limited · 2017 · recalledK131647 · Trinity Acetabular System · Corin USA · 2013K130343 · Corin Trinity Acetabular System with Extra-Long Heads · Corin USA · 2013 · recalledK110087 · Corin Trinity Acetbular System with Hxlpe Liners · Corin USA · 2011K103120 · Corin Biolox Delta Femoral Heads · Corin USA · 2011K100412 · Biolox Delta Ceramic Femoral Heads · Smith & Nephew, Inc. · 2010K082844 · Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset Sleeve · Encore Medical L.P. · 2008 · recalledK071535 · Biolox Delta Ceramic Femoral Head · Zimmer, Inc. · 2007 · recalledK061312 · 36MM Biolox Delta Ceramic Heads · Biomet, Inc. · 2006K051411 · Arcomxl Polyethylene Liners and Biolox Delta Heads · Biomet, Inc. · 2005 · recalledK042051 · Arcomxl Polyethylene Liners · Biomet, Inc. · 2005 · recalledK032396 · Ringloc 36MM Line and Modular Femoral Heads · Biomet, Inc. · 2003 · recalledK974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981−10−50
  1. Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 10 generations between
  3. 3 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
  4. 2 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
  5. 1 generation backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
  6. This deviceK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
Show all 14 generations
  1. Root · 14 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 13 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 12 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 11 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 10 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 9 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 8 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
  8. 7 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
  9. 6 generations backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
  10. 5 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
  11. 4 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
  12. 3 generations backK130343 Corin Trinity Acetabular System with Extra-Long HeadsCorin USA · 2013 · Recalled
  13. 2 generations backK131647 Trinity Acetabular SystemCorin USA · 2013
  14. 1 generation backK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
  15. This deviceK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−13K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−12K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−11K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−10K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−9K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−8K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20073
−7K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset…Encore Medical L.P.20081
−6K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010—
−5K103120Corin Biolox Delta Femoral HeadsCorin USA2011—
−4K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA2011—
−3K130343Corin Trinity Acetabular System with Extra-Long HeadsCorin USA20132
−2K131647Trinity Acetabular SystemCorin USA2013—
−1K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited20171
0 (this device)K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198410
198540
198630
198730
198820
199040
199160
199270
199360
1994260
1995190
1996200
1997150
1998150
1999160
2000270
2001150
2002140
2003150
2004110
2005150
2006120
2007120
200850
2009100
2010110
201190
201260
201340
201420
201530
201620
201730
201810
201930
202220
202310
FIG. 1 — Lineage of K253948, 1981–2026Source: 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? (12)

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
*K170359Trinity™ Dual Mobility System
Summary page 5
…8.3353 Product Codes LZO, OQI, MEH, LPH Predicate Device Information (Primary Predicate is listed first) 510(k) Number Predicate Trade Name K170359 Trinity TM Dual Mobility System K150522 G7 Dual Mobility System K190656 Dual Mobility…
Corin U.S.A. Limited20171
*K150522G7 Dual Mobility System
Summary page 5
…PH Predicate Device Information (Primary Predicate is listed first) 510(k) Number Predicate Trade Name K170359 Trinity TM Dual Mobility System K150522 G7 Dual Mobility System K190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings K…
Biomet, Inc.20151
*K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Summary page 5
…cate is listed first) 510(k) Number Predicate Trade Name K170359 Trinity TM Dual Mobility System K150522 G7 Dual Mobility System K190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings K190660 G7 Acetabular System K140…
Zimmer, Inc.20193
*K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…
Summary page 5
…Trinity TM Dual Mobility System K150522 G7 Dual Mobility System K190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings K190660 G7 Acetabular System K140669 G7 OsseoTiTM Acetabular Shells K121874 G7TM Acetabular S…
Zimmer, Inc.2019—
*K140669G7 Osseoti Acetublar Shells
Summary page 5
…G7 Dual Mobility System K190656 Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings K190660 G7 Acetabular System K140669 G7 OsseoTiTM Acetabular Shells K121874 G7TM Acetabular System K130128 Trinity No Hole…
Biomet, Inc.2014—
*K121874G7 Acetabular System
Summary page 5
…Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings K190660 G7 Acetabular System K140669 G7 OsseoTiTM Acetabular Shells K121874 G7TM Acetabular System K130128 Trinity No Hole Acetabular Shells K050262 U2 Acetabula…
Biomet Manufacturing Corp20123
*K130128Trinity Acetabular System
Summary page 5
…olyethylene Hip Bearings K190660 G7 Acetabular System K140669 G7 OsseoTiTM Acetabular Shells K121874 G7TM Acetabular System K130128 Trinity No Hole Acetabular Shells K050262 U2 Acetabular System K983382 Osteonics® HA…
Corin Medical2013—
*K050262U2 Acetabular Component
Summary page 5
…ular System K140669 G7 OsseoTiTM Acetabular Shells K121874 G7TM Acetabular System K130128 Trinity No Hole Acetabular Shells K050262 U2 Acetabular System K983382 Osteonics® HA Generation II Acetabular Component System K221149…
United Orthopedic Corp.2005—
*K983382Osteonics HA Generation II Acetabular Component System
Summary page 5
…iTM Acetabular Shells K121874 G7TM Acetabular System K130128 Trinity No Hole Acetabular Shells K050262 U2 Acetabular System K983382 Osteonics® HA Generation II Acetabular Component System K221149 U-Motion II Acetabular System K2216…
Osteonics Corp.19984
*K221149U-Motion II Acetabular System-Extension line
Summary page 5
…Trinity No Hole Acetabular Shells K050262 U2 Acetabular System K983382 Osteonics® HA Generation II Acetabular Component System K221149 U-Motion II Acetabular System K221636 EMPHASYS Acetabular System K220959 OR3O Dual Mo…
United Orthopedic Corporation2023—
*K221636EMPHASYS Acetabular System
Summary page 5
…2 U2 Acetabular System K983382 Osteonics® HA Generation II Acetabular Component System K221149 U-Motion II Acetabular System K221636 EMPHASYS Acetabular System K220959 OR3O Dual Mobility System…
Depuy Ireland UC2022—
*K220959OR3O Dual Mobility System
Summary page 5
…Osteonics® HA Generation II Acetabular Component System K221149 U-Motion II Acetabular System K221636 EMPHASYS Acetabular System K220959 OR3O Dual Mobility System 1…
Smith & Nephew, Inc.2022—

Also cleared against K170359: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 45 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
  • 87 of the 345 ancestors have a recall of any class.
  • 4 other devices also cite its predicate K170359.

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. 2026, 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 Momentum Acetabular Cup System is intended for use in total hip arthroplasty in skeletally mature patients for the

following conditions:

1. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4, Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head

involvement, unmanageable by other techniques.

5. Revision of previously failed total hip arthroplasty.

6. Dislocation risks.

The Momentum Acetabular Cup System implants are single use implants intended for cementless use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K170359

4 other devices cite the same predicate.

  • K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System…Corin, Ltd. · 2021
  • K191831MobiliT CupCorin U.S.A. Limited · 2020
  • K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc. · 2019
  • K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 20191 recall

More from United Orthopedic Corporation

41 FDA decisions under this applicant name. See the company

  • 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
  • K243466Conformity Stem Extension Line, #0United Orthopedic Corporation · 2025

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026
  • K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K253948 · printed Nov 5, 2026

Cite this page

510(k) Report. “K253948: Momentum Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253948

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026