# K884796: P.F.C.(TM) Modular Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Mar 29, 1989 after 133 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: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 5 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K954818: Consensus Posterior Stabilized Knee (1996), 9 descendants of its own
- K984158: P.F.C. Modular Plus Offset Tibial Tray (1999), 7 descendants of its own
- K163167: CKS Plus Knee System (2017), 3 descendants of its own
- K013906: HLS Noetos System (2002), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own

## Recalls of this device
- Jun 28, 2011 · Not classified · Z-3099-2011: DePuy initiated a voluntary recall effective immediately, for one lot of P.F.C. SIGMA RD Dome Patella 3 Peg (38mm) due to packaging labels that did not correctly reflect the size of the enclosed patel
- May 26, 2005 · Not classified · Z-1338-05: 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-1333-05: 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-1337-05: 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-1335-05: 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-1336-05: 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-1342-05: 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-1332-05: 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-1346-05: 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-1334-05: 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-1339-05: 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-1343-05: 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-1345-05: 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-1344-05: 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-1340-05: 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-1341-05: 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.

Source page: https://510kreport.com/device/K884796
Methodology: https://510kreport.com/methodology