510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

G7 Dual Mobility System

K150522510(k) TraditionalCleared May 1, 201560-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

Biomet, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on May 1, 2015 as substantially equivalent to K101336 (Biomet Manufacturing Corp, 2011) and 2 other predicates after a 60-day review. Its family tree reaches back 10 generations to 1981. 21 later devices descend from it. It has been recalled once.

Decided
May 1, 2015
Review
60 days
Class
Class II
Product code
LPH
Recalls
1
Predicates
3

Its longest line of descent runs back 10 generations to K810258 (1981). 59 ancestors in all. 21 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2009: 3 other ancestors2007: 4 other ancestors2006: 1 other ancestor2005: 3 other ancestors2004: 2 other ancestors2001: 3 other ancestors1999: 2 other ancestors2008: 1 other ancestor2003: 3 other ancestors2002: 3 other ancestors2000: 1 other ancestor1997: 2 other ancestors1998: 1 other ancestor1996: 2 other ancestors1995: 5 other ancestors1994: 4 other ancestors1993: 1 other ancestor1992: 3 other ancestors1985: 1 other ancestor1991: 2 other ancestors1988: 1 other ancestor2019: 4 descendants cleared2025: 2 descendants cleared2021: 4 descendants cleared2016: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2026: 2 descendants cleared2024: 3 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant clearedReference device: K991990 · Tri-Polar System · Biomet, Inc. · 1999K810258 · 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. · 2006K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010×2: 2 generations cleared close together, K101336 (2011), K110555 (2011) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 11 other ancestors3 generations back: 9 other ancestors4 generations back: 19 other ancestors5 generations back: 8 other ancestors6 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 9 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K110555 · Arcomxl Active Articulation · Biomet Manufacturing Corp · 2011 · recalledK101336 · E1 Avantage Head · Biomet Manufacturing Corp · 2011 · recalledK100048 · E1 Antioxidant Infused Technology · Biomet Manufacturing Corp · 2010K073102 · Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners · Biomet Manufacturing Corp · 2007K061312 · 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 · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 6 generations between
  3. 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  4. 2 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
  5. 1 generation backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
  6. This deviceK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015
  7. Descendant · cites it directly · 10 of its ownK170359 Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · Recalled
  8. Descendant · cites it directly · 7 of its ownK161190 G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
  9. Descendant · 2 generations on · 3 of its ownK191831 MobiliT CupCorin U.S.A. Limited · 2020
  10. Descendant · 2 generations on · 3 of its ownK190535 BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · Recalled
  11. Descendant · 2 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
Show all 10 generations
  1. Root · 10 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 9 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. 8 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
  4. 7 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
  5. 6 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
  6. 5 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
  7. 4 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
  8. 3 generations backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
  9. 2 generations backK101336 E1 Avantage HeadBiomet Manufacturing Corp · 2011 · Recalled
  10. 1 generation backK110555 Arcomxl Active ArticulationBiomet Manufacturing Corp · 2011 · Recalled
  11. This deviceK150522 G7 Dual Mobility SystemBiomet, Inc. · 2015

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2016: 12017: 12018: 12019: 42020: 12021: 42022: 12023: 12024: 32025: 22026: 2
2016high 4 (2019) · low 1 (2016)2026

Most influential descendants

Showing 5 of 21 · See all
  • K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited · 2017 · cites it directly10descendants
  • K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016 · cites it directly7descendants
  • K191831MobiliT CupCorin U.S.A. Limited · 2020 · 2 generations on3descendants
  • K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG · 2019 · 2 generations on3descendants
  • K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−9K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
−8K032396Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc.20033
−7K042051Arcomxl Polyethylene LinersBiomet, Inc.20051
−6K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20051
−5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006—
−4K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007—
−3K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010—
−2K101336E1 Avantage HeadBiomet Manufacturing Corp20111
−1K110555Arcomxl Active ArticulationBiomet Manufacturing Corp20112
0 (this device)K150522G7 Dual Mobility SystemBiomet, Inc.2015—
+1K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited20171
+1K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.2016—
+2K191831MobiliT CupCorin U.S.A. Limited2020—
+2K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG20191
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular…Corin, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198810
199120
199230
199310
199440
199550
199620
199720
199810
199920
200010
200130
200230
200330
200420
200530
200610
200740
200810
200930
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201710
201810
201940
202010
202140
202210
202310
202430
202520
202620
FIG. 1 — Lineage of K150522, 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 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
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
*K101336E1 Avantage Head
Summary page 4
…Cemented or Non‐Porous, Uncemented (21 CFR 888.3353) Legally marketed devices to which substantial equivalence is claimed:  Biomet E1 Avantage Head (K101336)  ArComXL Active Articulation Head (K110555)  Stryker MDM (K103233)  Biomet Tri‐Polar (K991990) ‐ Reference Device D…
Biomet Manufacturing Corp20111
*K110555Arcomxl Active Articulation
Summary page 4
…ed (21 CFR 888.3353) Legally marketed devices to which substantial equivalence is claimed:  Biomet E1 Avantage Head (K101336)  ArComXL Active Articulation Head (K110555)  Stryker MDM (K103233)  Biomet Tri‐Polar (K991990) ‐ Reference Device Description The G7 Dual Mobility system consists…
Biomet Manufacturing Corp20112
*K103233Modular Dual Mobility Liner, X3 Acetabular Insert
Summary page 4
…ly marketed devices to which substantial equivalence is claimed:  Biomet E1 Avantage Head (K101336)  ArComXL Active Articulation Head (K110555)  Stryker MDM (K103233)  Biomet Tri‐Polar (K991990) ‐ Reference Device Description The G7 Dual Mobility system consists of two articulating surface…
Howmedica Osteonics Corp.20111
†K991990Tri-Polar SystemBiomet, Inc.1999—

Also cleared against K101336: 3 other devices →

What descends from it? (21)

See all 21

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

NumberDeviceApplicantDecidedDescendants
K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited201710
K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167
K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211
K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG20211
K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181
K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260
K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250
K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.20210
K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 6, 2023Class IIZ-1284-2023Under Investigation by firmThe outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 34 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 16 of the 59 ancestors have a recall of any class.
  • Of its descendants, K170359 (Corin U.S.A. Limited, 2017) has gone furthest, with 10 descendants of its own.
  • 3 other devices also cite its predicate K101336.

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. 2015, 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?

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 Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

Indications for use as stated in the FDA summary.

Also cleared against K101336

3 other devices cite the same predicate.

  • K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc. · 2016
  • K111981Tregor Dual Mobility Acetabular SystemAston Medical · 2012
  • K110555Arcomxl Active ArticulationBiomet Manufacturing Corp · 20112 recalls

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

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/K150522 · printed Nov 3, 2026

Cite this page

510(k) Report. “K150522: G7 Dual Mobility System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150522

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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