510(k) Report

510(k) · Cleared

Cleared

G7 Osseoti Acetublar Shells

K140669510(k) TraditionalCleared Dec 11, 2014268-day reviewClass II21 CFR 888.3358

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 Dec 11, 2014 as substantially equivalent to K121874 (Biomet Manufacturing Corp, 2012) and 2 other predicates after a 268-day review. Its family tree reaches back 10 generations to 1981. 35 later devices descend from it.

Decided
Dec 11, 2014
Review
268 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K810258 (1981). 97 ancestors in all. 35 later devices descend from it, 11 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2010: 4 other ancestors2011: 1 other ancestor2009: 2 other ancestors2007: 4 other ancestors2005: 5 other ancestors2003: 5 other ancestors1991: 2 other ancestors2002: 4 other ancestors2001: 5 other ancestors2000: 7 other ancestors1999: 6 other ancestors1996: 6 other ancestors1994: 14 other ancestors1983: 1 other ancestor2004: 2 other ancestors1998: 1 other ancestor1997: 4 other ancestors1995: 5 other ancestors1993: 3 other ancestors1992: 2 other ancestors1986: 2 other ancestors1985: 1 other ancestor2018: 2 descendants cleared2019: 5 descendants cleared2020: 1 descendant cleared2015: 1 descendant cleared2023: 3 descendants cleared2022: 4 descendants cleared2026: 8 descendants cleared2021: 2 descendants cleared2025: 3 descendants cleared2024: 6 descendants clearedReference device: K122770 · Biomet Reconstructive Wedges Model 110003660-99, 110003797-831 · Biomet Manufacturing Corp · 2013Reference device: K052996 · Porous Titanium Acetabular Shells · Biomet Manufacturing Corp · 2006K810258 · 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 · 2007K082996 · Biolox Delta Option Ceramic Heads · Biomet, Inc. · 2009 · recalledK093549 · 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum · Biomet Manufacturing Corp · 2009K121874 · G7 Acetabular System · Biomet Manufacturing Corp · 2012 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors3 generations back: 20 other ancestors4 generations back: 19 other ancestors5 generations back: 22 other ancestors6 generations back: 12 other ancestors7 generations back: 4 other ancestors 1 generation forward: 11 descendants2 generations forward: 16 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants K121874 · G7 Acetabular System · Biomet Manufacturing Corp · 2012 · recalledK093549 · 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum · Biomet Manufacturing Corp · 2009K082996 · Biolox Delta Option Ceramic Heads · Biomet, Inc. · 2009 · recalledK073102 · 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 backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
  4. 2 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  5. 1 generation backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  6. This deviceK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
  7. Descendant · cites it directly · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
  8. Descendant · cites it directly · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
  9. Descendant · 2 generations on · 4 of its ownK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
  10. Descendant · cites it directly · 4 of its ownK172551 Trinity PLUS Acetabular ShellCorin U.S.A. Limited · 2018
  11. Descendant · 2 generations on · 3 of its ownK240299 Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. · 2024
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 backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
  9. 2 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
  10. 1 generation backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
  11. This deviceK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2015: 12018: 22019: 52020: 12021: 22022: 42023: 32024: 62025: 32026: 8
2015high 8 (2026) · low 0 (2016)2026

Most influential descendants

Showing 5 of 35 · See all
  • K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · cites it directly8descendants
  • K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019 · cites it directly8descendants
  • K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019 · 2 generations on4descendants
  • K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited · 2018 · cites it directly4descendants
  • K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc. · 2024 · 2 generations on3descendants
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—
−3K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.20094
−2K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M…Biomet Manufacturing Corp2009—
−1K121874G7 Acetabular SystemBiomet Manufacturing Corp20123
0 (this device)K140669G7 Osseoti Acetublar ShellsBiomet, Inc.2014—
+1K221479Persona Personalized Knee SystemZimmer, Inc.2022—
+1K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG2019—
+2K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG2019—
+1K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited2018—
+2K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198620
199120
199220
199330
1994140
199550
199660
199740
199810
199960
200070
200150
200240
200350
200420
200550
200740
200920
201040
201110
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201820
201950
202010
202120
202240
202330
202460
202530
202680
FIG. 1 — Lineage of K140669, 1981–2026Source: 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? (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
*K121874G7 Acetabular System
Summary page 5
…K140669 Page 2 of 3 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: G7 Acetabular System—K121874 (Biomet) Exactech Novation Crown Cup with InteGrip—K102975 and K122798 (Exactech) Reference predicates include K122770, Biomet R…
Biomet Manufacturing Corp20123
*K102975Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole
Summary page 5
…Page 2 of 3 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: G7 Acetabular System—K121874 (Biomet) Exactech Novation Crown Cup with InteGrip—K102975 and K122798 (Exactech) Reference predicates include K122770, Biomet Reconstructive Wedges, which first introduced Biomet’s addit…
Exactech, Inc.2010—
*K122798Integrip Acetabular Shell, Integrip Revision Acetabular Shell
Summary page 5
…f 3 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: G7 Acetabular System—K121874 (Biomet) Exactech Novation Crown Cup with InteGrip—K102975 and K122798 (Exactech) Reference predicates include K122770, Biomet Reconstructive Wedges, which first introduced Biomet’s additive manufact…
Exactech, Inc.2012—
†K122770Biomet Reconstructive Wedges Model 110003660-99, 110003797-831Biomet Manufacturing Corp2013—
†K052996Porous Titanium Acetabular ShellsBiomet Manufacturing Corp2006—

Also cleared against K121874: 10 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K221479Persona Personalized Knee SystemZimmer, Inc.20228
K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198
K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited20184
K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193
K182099Delta TT ProLima Corporate S.P.A.20183
K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192
K142814Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialBiomet Manufacturing, LLC20151
K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260
K252623G7® Revision Acetabular SystemZimmer, Inc.20260
K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230

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 33 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
  • 24 of the 97 ancestors have a recall of any class.
  • Of its descendants, K221479 (Zimmer, Inc., 2022) has gone furthest, with 8 descendants of its own.
  • 10 other devices also cite its predicate K121874.

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. 2014, 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 procedures where other treatment or devices have failed. Porous acetabular shells and femoral stems are indicated for uncemented…

Read the full statement (149 words)

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 procedures where other treatment or devices have failed.

Porous acetabular shells and femoral stems are indicated for uncemented biological

fixation. Non-coated or polyethylene components may be used with mating

components that are indicated for either cemented or uncemented use.

Additional indications for Biomet G7 Freedom ™ Constrained Liners:

The Biomet G7 Freedom™ Constrained Liner is indicated for use as a component of a

total hip prosthesis in primary and revision patients at high risk of dislocation due to a

history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease,

or intraoperative instability, and for whom all other options to constrained acetabular

components have been considered.

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 K121874

10 other devices cite the same predicate.

  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc. · 2022
  • K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc. · 2019
  • K190057DJO Acetabular SystemEncore Medical L.P. · 20195 recalls
  • K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
  • K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd. · 2019

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/K140669 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140669: G7 Osseoti Acetublar Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140669

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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