# K030623: Smith & Nephew Profix Total Knee System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: May 22, 2003 after 84 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853730 (1986). 5 ancestors in all.
78 later devices descend from it; 5 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933958: Richards Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K954909: Profix Posterior-Stabilized Knee System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K963255: Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.
- K884824: Tricon-M Total Knee System, Richards Medical Co., Inc. (1989) Summary page 1.
- K853730: Freeman-Samuelson Mark II Press-Fit Total Knee Rep, Protek, Inc. (1986) Summary page 1.

## Most influential descendants
- 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
- K080361: Regenerex Tibial Components (2008), 13 descendants of its own

## Indications for use
The Profix Total Knee System is indicated for: 1. Rheumatoid arthntis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-tern result. 3. Failed osteotomies, unicornpartmental replacement, or total knee replacement. 4. The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. The Profix Total Knee System includes porous coated devices which are indicated for use without bone cement, and are single use devices.

Source page: https://510kreport.com/device/K030623
Methodology: https://510kreport.com/methodology