# K971189: P.F.C. Sigma Knee System (Size 1.5)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jul 17, 1997 after 107 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
No predicates in its family tree.
356 later devices descend from it; 7 cite it directly.
0 of 357 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. Sigma 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
- K101433: Depuy Attune Knee System (2010), 114 descendants of its own
- K092122: Global Shoulder Steptech Anchor Peg Glenoid (2009), 75 descendants of its own

## Indications for use
The P.F.C. Sigma Knee System (Size 1.5) 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/K971189
Methodology: https://510kreport.com/methodology