# K946236: Profix Conforming Plus Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Jul 6, 1995 after 196 days
- Product code: KWH (Prosthesis, Toe, Constrained, Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 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) Ortholoc Modular Total Condylar System: named in the summary without a submission number
- (no number) Miller/Gallante Revision System: named in the summary without a submission number
- (no number) MG II Total Knee System: named in the summary without a submission number
- (no number) New Jersey LCS Total Knee System: named in the summary without a submission number
- (no number) Duracon Total Knee System: named in the summary without a submission number

## 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
This device is intended for use in patients with 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; and failed osteotomies or unicompartmental replacement.

Source page: https://510kreport.com/device/K946236
Methodology: https://510kreport.com/methodology