# K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jul 10, 1996 after 70 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: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
430 later devices descend from it; 13 cite it directly.
0 of 431 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.® Cruciate Retaining Knee System: named in the summary without a submission number

## Most influential descendants
- K033272: Depuy Sigma Tibial Inserts (2004), 351 descendants of its own
- K040166: Depuy Sigma XLK Tibial Inserts (2004), 324 descendants of its own
- K052472: Depuy Global Shoulder Crosslink Glenoid (2005), 158 descendants of its own
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components (2006), 120 descendants of its own
- K082500: Depuy Sigma CR-F Femoral Component (2008), 115 descendants of its own

## Recalls of this device
- Sep 14, 2006 · Not classified · Z-0057-2007: Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
- May 26, 2005 · Not classified · Z-1317-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1315-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1319-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1316-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1320-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
- May 26, 2005 · Not classified · Z-1318-05: An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

## Indications for use
The P.F.C.® Cruciate Retaining Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

Source page: https://510kreport.com/device/K961685
Methodology: https://510kreport.com/methodology