# K121874: G7 Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 23, 2012 after 149 days
- Product code: PBI (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 74 ancestors in all.
53 later devices descend from it; 11 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093235: Ringloc + Hybrid Acetabular System, Biomet, Inc. (2010) Summary page 3.
- K033442: Reflection Constrained Liner, Smith & Nephew, Inc. (2003) Summary page 2.
- K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI, Zimmer, Inc. (2011) Summary page 2.
- K093549: 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a Magnum, Biomet Manufacturing Corp (2009) Summary page 2.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 2.
- K911684: Biomet Cobalt-Chrome Femoral Components, Biomet, Inc. (1991) Summary page 2.
- K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009)
- K030047: Freedom Constrained Liners, Biomet, Inc. (2003) Summary page 3.

## Most influential descendants
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32 (2015), 17 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own

## Recalls of this device
- Aug 25, 2022 · Class II · Z-0007-2023: 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 cli
- May 7, 2014 · Class II · Z-1837-2014: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K121874
Methodology: https://510kreport.com/methodology