510(k) · Cleared
ClearedG7® Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Sep 23, 2026 as substantially equivalent to K190660 (Zimmer, Inc., 2019) after a 145-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- Sep 23, 2026
- Review
- 145 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K810258 (1981). 88 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 2 generations backK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- 1 generation backK190660 G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7…Zimmer, Inc. · 2019
- This deviceK261453 G7® Acetabular SystemZimmer Biomet · 2026
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 5 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 4 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 3 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 2 generations backK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- 1 generation backK190660 G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7…Zimmer, Inc. · 2019
- This deviceK261453 G7® Acetabular SystemZimmer Biomet · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −5 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −4 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| −3 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| −2 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| −1 | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular… | Zimmer, Inc. | 2019 | — |
| 0 (this device) | K261453 | G7® Acetabular System | Zimmer Biomet | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 12 | 0 |
| 1995 | 6 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 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 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 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Summary page 5…onstrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21CFR 888.3353) Predicate Device: K190660 – G7 Acetabular System, Zimmer, Inc. Reference Devices: K990135 – Trilogy Longevity, Zimmer, Inc. K0429… | 2019 |
| † | K990135 | Trilogy Acetabular System Longevity Crosslinked Polyethylene | 1999 |
| † | K042989 | RX90 Low Profile Acetabular System | 2005 |
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 4 companies; a new generation was cleared every 2.2 years on median.
- 23 of the 88 ancestors have a recall of any class.
- 3 other devices also cite its predicate K190660.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261453: 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/K261453
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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