# K193540: TRUMATCH Personalized Solutions

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 16, 2020 after 179 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: 1 generation back to K110397 (2011). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110397: Trumatch Personalized Solutions, DePuy Orthopaedics, Inc. (2011) Summary page 4.

## Indications for use
The TruMatch 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 TruMatch Patient Specific Instruments must be present and identifiable on CT. The TruMatch Patient Specific Instruments are intended for use with Sigma Total Knee Implants and Attune Total Knee Implants and their cleared indications for use. The TruMatch Patient Specific Instruments are intended for single use only.

Source page: https://510kreport.com/device/K193540
Methodology: https://510kreport.com/methodology