# K051229: Profix  Flex Cruciate Retaining Articular Insert

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 20, 2005 after 68 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
Longest line of descent: 4 generations back to K951987 (1995). 12 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 27 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.
- K030623: Smith & Nephew Profix Total Knee System, Smith & Nephew, Inc. (2003) Summary page 1.
- K041825: Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular Insert, Smith & Nephew, Inc. (2005) Summary page 2.

## Most influential descendants
- K113482: Journey II Deep Dished Articular Inserts (2012), 6 descendants of its own
- K121393: Smith & Nephew, Inc. Total Knee System Instrumentation (2012), 5 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K123159: Smith & Newphew, Inc. Disposable Knee Instruments (2013), 2 descendants of its own
- K211671: Journey II Mid-Level Tibial Inserts (2021), 1 descendant of its own

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).

Source page: https://510kreport.com/device/K051229
Methodology: https://510kreport.com/methodology