510(k) · Cleared
ClearedG7® Vivacit-E® Freedom® Constrained Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Cleared on Apr 28, 2022 as substantially equivalent to K121874 (Biomet Manufacturing Corp, 2012) and 1 other predicate after a 261-day review. Its family tree reaches back 11 generations to 1981.
- Decided
- Apr 28, 2022
- Review
- 261 days
- Class
- Class II
- Product code
- PBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K810258 (1981). 77 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations between
- 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- This deviceK212512 G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 10 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 9 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 8 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 7 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 6 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 5 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 4 generations backK082996 Biolox Delta Option Ceramic HeadsBiomet, Inc. · 2009 · Recalled
- 3 generations backK093549 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head…Biomet Manufacturing Corp · 2009
- 2 generations backK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- 1 generation backK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- This deviceK212512 G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −10 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −9 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −8 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −7 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −6 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −5 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −4 | K082996 | Biolox Delta Option Ceramic Heads | Biomet, Inc. | 2009 | 4 |
| −3 | K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M… | Biomet Manufacturing Corp | 2009 | — |
| −2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| −1 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| 0 (this device) | K212512 | G7® Vivacit-E® Freedom® Constrained Liner | Zimmer, Inc. | 2022 | — |
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 | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K121874 | G7 Acetabular SystemSummary page 5…nonporous uncemented prosthesis) Predicate Device(s): 510(k) Number Device Name Applicant K121874 (primary) G7 E1 ® Freedom Biomet and K142882 Constrained Liner Orthopedics… | 2012 |
| * | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32Summary page 5…510(k) Number Device Name Applicant K121874 (primary) G7 E1 ® Freedom Biomet and K142882 Constrained Liner Orthopedics Reference Predicate: 510(k) Number Device Name… | 2015 |
| † | K071718 | Trilogy Longevity Constrained Liner | 2007 |
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 41 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 19 of the 77 ancestors have a recall of any class.
- 10 other devices also cite its predicate K121874.
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. 2022, 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) Noninflammatory 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 (147 words)
1) Noninflammatory 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.
Indications for G7® Vivacit-E® Freedom® Constrained Liner:
The G7® Vivacit-E® 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.
https://510kreport.com/device/K212512 · printed Nov 5, 2026
Cite this page
510(k) Report. “K212512: G7® Vivacit-E® Freedom® Constrained Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K212512
Report an extraction error
Are you the manufacturer?
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