# K963255: Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Jan 2, 1997 after 136 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.
79 later devices descend from it; 2 cite it directly.
0 of 80 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 no predicate by number.

## Most influential descendants
- K030623: Smith & Nephew Profix Total Knee System (2003), 78 descendants of its own
- K033489: Agc Total Knee System Knee, Ascent Total Knee System, Maxim Complete Knee System, Maxim Accel Knee System Also Known (2004), 60 descendants of its own
- K060303: Vanguard PS Open Box Porous Femoral Components (2006), 47 descendants of its own
- K113550: Vanguard Complete Knee System (2012), 46 descendants of its own
- K051229: Profix  Flex Cruciate Retaining Articular Insert (2005), 14 descendants of its own

## Indications for use
The Profix Plus Tibial Insert when used with the Profix Knee System is designed for patients with the following indications: 1) Rheumatoid arthritis 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Profix Plus Tibial Insert is also indicated for use where a knee cannot be stabilized by soft tissue release. The Profix Plus Tibial Insert is part of a system that is indicated for use only with cement and is a single use device.

Source page: https://510kreport.com/device/K963255
Methodology: https://510kreport.com/methodology