510(k) · Cleared
Recalled · Class II · 2022G7 Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Cleared on Nov 23, 2012 as substantially equivalent to K093235 (Biomet, Inc., 2010) and 7 other predicates after a 149-day review. Its family tree reaches back 9 generations to 1981. 53 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 23, 2012
- Review
- 149 days
- Class
- Class II
- Product code
- PBI
- Recalls
- 3
- Predicates
- 8
Its longest line of descent runs back 9 generations to K810258 (1981). 74 ancestors in all. 53 later devices descend from it, 11 citing it directly.
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 5 generations between
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 1 generation backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- This deviceK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012
- Descendant · cites it directly · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · cites it directly · 17 of its ownK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- Descendant · 2 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · cites it directly · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- Descendant · 2 generations on · 4 of its ownK192559 Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG · 2019
Show all 9 generations
- Root · 9 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 7 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 6 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 5 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 4 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 3 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 2 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 1 generation backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- This deviceK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · cites it directly35descendants
- K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015 · cites it directly17descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 2 generations on8descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −8 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −7 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −6 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −5 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −4 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −3 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −2 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −1 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| 0 (this device) | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | — |
| +1 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +1 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| +2 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +1 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
| +2 | K192559 | Acetabular Bone Screws (for MobileLink Acetabular Cup System) | Waldemar Link GmbH & Co. KG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 12 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2005 | 4 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 12 | 0 |
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 PBI? 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 PBI device
- #1 K212512 G7® Vivacit-E® Freedom® Constrained Linerscore 6.2 · 11 generations · no Class I recall
What was it cleared against? (8)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093235 | Ringloc + Hybrid Acetabular SystemSummary page 3…proposed device are the same as or similar to the predicates. The G7' M acetabular shells are similar in design, dimensions, and intended use to their Biomet predicate, K093235, but have incorporated a different locking mechanism, which is also similar to legally marketed predicates, KO915O8 and K(103662.… | 2010 |
| * | K033442 | Reflection Constrained LinerSummary page 2…Substantial Equivalence Is Claimed: Ace ta b uInr Sh ells: Porous Plasma Spray (PPSS) RingLoc®+ Acetabular System, K(093235 (Biomet) Reflection Acetabular Cup System, K(033442 (Smith and Nephew) Continuum Acetabular System, K(103662 (Zimmer) Acetabular Liners: Ringlocs E18 Acetabular Liners, K(093549 (B… | 2003 |
| * | K103662 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly…Summary page 2…s: Porous Plasma Spray (PPSS) RingLoc®+ Acetabular System, K(093235 (Biomet) Reflection Acetabular Cup System, K(033442 (Smith and Nephew) Continuum Acetabular System, K(103662 (Zimmer) Acetabular Liners: Ringlocs E18 Acetabular Liners, K(093549 (Biomet) Reflection Acetabular Cup System, K(033442 (Smith… | 2011 |
| * | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumSummary page 2…iomet) Reflection Acetabular Cup System, K(033442 (Smith and Nephew) Continuum Acetabular System, K(103662 (Zimmer) Acetabular Liners: Ringlocs E18 Acetabular Liners, K(093549 (Biomet) Reflection Acetabular Cup System, K(033442 (Smith and Nephew) Continuum Acetabular System, K(103662 (Zimmer) Constraine… | 2009 |
| * | K043537 | Taperloc 12/14 Taper Femoral ComponentsSummary page 2…Reflection Acetabular Cup System, K(033442 (Smith and Nephew) Continuum Acetabular System, K(103662 (Zimmer) Constrained Heads and Liners: Freedom Constrained Liners, K(043537 (Biomet) Cobalt Chrome Femoral Heads: Cobalt Chrome Femoral Components, K(911684 (Biomet) Device Description: The G7TM Acetabul… | 2005 |
| * | K911684 | Biomet Cobalt-Chrome Femoral ComponentsSummary page 2…r System, K(103662 (Zimmer) Constrained Heads and Liners: Freedom Constrained Liners, K(043537 (Biomet) Cobalt Chrome Femoral Heads: Cobalt Chrome Femoral Components, K(911684 (Biomet) Device Description: The G7TM Acetabular System is a modular system, designed to provide numerous options for surgeons… | 1991 |
| * | K091508 | Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System | 2009 |
| * | K030047 | Freedom Constrained LinersSummary page 3…nstrained head is a line extension to the Biomet Freedom-m constrained heads, and the constrained liners use the same design principles as the Freedom liner predicate, K(030047. The cobalt chrome femoral heads are very similar to the Biomet predicate, K(911684. Non-Clinical Testing: The following testin… | 2003 |
What descends from it? (53)
See all 5311 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140669 | G7 Osseoti Acetublar Shells | 2014 | 35 |
| K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | 2015 | 17 |
| K182321 | MobileLink Acetabular Cup System | 2019 | 8 |
| K183582 | MPACT Extension | 2019 | 4 |
| K182221 | Bencox Mirabo Cup Multi Hole | 2019 | 3 |
| K190057 | DJO Acetabular System | 2019 | 2 |
| K253948 | Momentum Acetabular Cup System | 2026 | 0 |
| K212512 | G7® Vivacit-E® Freedom® Constrained Liner | 2022 | 0 |
| K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | 2019 | 0 |
| K173380 | b-ONE® Total Hip System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2022 | Class II | Z-0007-2023 | Under Investigation by firm | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of… |
| May 7, 2014 | Class II | Z-1837-2014 | Use error | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. |
| May 7, 2014 | Class II | Z-1838-2014 | Use error | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 18 of the 74 ancestors have a recall of any class.
- Of its descendants, K140669 (Biomet, Inc., 2014) has gone furthest, with 35 descendants of its own.
- 2 other devices also cite its predicate K093235.
How does its category compare?
All PBI devicesPBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PBI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PBI
Too few PBI 510(k)s in any year since 2007 to give a median.
Recalls per year · PBI
No recall names PBI since 2007.
Adverse event reports per year · PBI
234in 2025
MAUDE reports naming product code PBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 0 | — | 0 | 199 |
| 2017 | 0 | — | 0 | 231 |
| 2018 | 0 | — | 0 | 278 |
| 2019 | 0 | — | 0 | 245 |
| 2020 | 0 | — | 0 | 185 |
| 2021 | 0 | — | 0 | 133 |
| 2022 | 1 | — | 0 | 128 |
| 2023 | 0 | — | 0 | 255 |
| 2024 | 0 | — | 0 | 255 |
| 2025 | 0 | — | 0 | 234 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatdid 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. Acetabular shells and femoral stems with porous coatings are indicated…
Read the full statement (151 words)
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatdid 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.
Acetabular shells and femoral stems with porous coatings 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.
Indications for Biomet G7 Freedom TM Constrained Liners:
The Biomet G7 Freedom 'n 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 as stated in the FDA summary.
https://510kreport.com/device/K121874 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121874: G7 Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121874
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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