# K122975: GKS Prime Flex CR Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Permedica
- Decided: Dec 20, 2012 after 85 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941847 (1994). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023211: Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components, Zimmer, Inc. (2002) Summary page 1.
- K072281: Nexgen Prolong All-Poly Patella, Zimmer, Inc. (2007) Summary page 1.
- K933785: Next Generation Knee System, Zimmer, Inc. (1995) Summary page 1.
- K081023: Evolis Total Knee System, Medacta International S.A. (2008) Summary page 1.
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 1.
- K110950: Consensus Knee System, Consensus Orthopedics, Inc. (2011) Summary page 1.
- K971189: P.F.C. Sigma Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1997) Summary page 1.

## Indications for use
G.K.S. PRIME FLEX CR is indicated for use in patients with severely painful and disabled joints due to: * Osteoarthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis * Failed osteotomies " Avascular necrosis of femoral condyle " Post traumatic loss of joint configuration * Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability * Primary implantation failure if there is sufficient bone The device is intended for cemented use only.

Source page: https://510kreport.com/device/K122975
Methodology: https://510kreport.com/methodology