# K962190: Patellofemoral Joint Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Oct 28, 1996 after 144 days
- Product code: KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bechtol Patello-Femoral Joint Replacement; Smith and Nephew Richards, Inc.: named in the summary without a submission number
- (no number) Type 1 Femoral Component; Smith and Nephew Richards, Inc.: named in the summary without a submission number
- (no number) Type II Femoral Component; Smith and Nephew Richards, Inc.: named in the summary without a submission number
- (no number) Lubinus Total Patella Glide Femoral Component; Waldemar Link: named in the summary without a submission number

## Indications for use
The general indications associated with the use of Patellofemoral Joint Prosthesis in patellofemoral arthroplasty include: 1. Patients with osteoarthritis in the distal femur and patella. 2. Patients with a history of patellar dislocation or patellar fracture. 3. Those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dvsfunction persists.

Source page: https://510kreport.com/device/K962190
Methodology: https://510kreport.com/methodology