# K110397: Trumatch Personalized Solutions

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Aug 16, 2011 after 186 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Smith & Nephew Patient Matched Cutting Blocks: named in the summary without a submission number
- (no number) traditional instruments associated with the Sigma and Attune cleared knee implant systems: named in the summary without a submission number

## Most influential descendants
- K193540: TRUMATCH Personalized Solutions (2020), 0 descendants of its own

## Indications for use
The TruMatchTM Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting. The anatomical landmarks necessary for the creation of the TruMatchTM Patient Specific Instruments must be present and identifiable on CT. The TruMatchTM Patient Specific Instruments are intended for use with Sigma® Total Knee Implants and AttuneTm Total Knee Implants and their cleared indications for use. The TruMatchTm Patient Specific Instruments are intended for single use only.

Source page: https://510kreport.com/device/K110397
Methodology: https://510kreport.com/methodology