# K954481: P.F.C. Uni-Compartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Oct 10, 1996 after 379 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 2 cite it directly.
0 of 61 devices 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) P.F.C.® Uni-compartmental Knee System: named in the summary without a submission number

## Most influential descendants
- K040268: Depuy Preservation Unicondylar Tibia (2004), 47 descendants of its own
- K063432: Conformis Metal Backed Tibial Component (MBT) (2007), 32 descendants of its own
- K072368: Conformis Metal Backed Tibial Component (2007), 31 descendants of its own
- K092441: Modification to: Conformis Iuni Unicondylar Knee Repair System (2009), 29 descendants of its own
- K111916: Conformis Iuni Unicondylar Knee Replacement System (2011), 28 descendants of its own

## Indications for use
The P.F.C.® §, Uni-Compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only with bone cement.

Source page: https://510kreport.com/device/K954481
Methodology: https://510kreport.com/methodology