Trumatch Personalized Solutions
by Depuy Orthopaedics, Inc. 2 variants
510(k) K110397
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK110397 | Date16 Aug 2011 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JWH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Trumatch Personalized Solutions is a web-based surgical planning system designed for personalized orthopedic procedures. It provides patient-specific anatomical analysis and planning for total knee and shoulder arthroplasty, including both anatomic and reverse shoulder replacements. The system leverages advanced digital tools to generate tailored surgical strategies based on individual patient anatomy.
The system is supplied as a digital interface, requiring internet connectivity for access. It is intended for use in preoperative planning by orthopedic surgeons and is not a physical medical device. No regulatory approvals beyond the FDA 510K clearance (K110397) are stated, and sterility or single-use/reusable classifications do not apply. The solution integrates with the ATTUNE Knee System for knee procedures and supports 3D anatomical assessment for shoulder arthroplasty.
Other devices from Depuy Orthopaedics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Trumatch Personalized Solutions system used for?
The Trumatch Personalized Solutions system is a web-based tool designed specifically for preoperative planning in orthopedic surgery. It provides patient-specific anatomical analysis and generates customized surgical strategies for total knee arthroplasty (including the ATTUNE Knee System) and shoulder arthroplasty, covering both anatomic and reverse shoulder replacements. By leveraging advanced digital tools, it helps surgeons create precise, individualized treatment plans based on a patient’s unique anatomy.
How is the Trumatch Personalized Solutions system supplied and accessed?
The system is supplied exclusively as a digital interface and requires an internet connection to access. It is not a physical medical device, meaning there are no hardware components or packaging to consider. Users must have a compatible device and stable internet access to utilize its features for surgical planning.
Is the Trumatch Personalized Solutions system sterile or single-use?
The Trumatch Personalized Solutions system is neither sterile nor classified as single-use or reusable, as it is a software-based solution. Sterility and reuse classifications apply only to physical medical devices, and this system does not fall into that category. Its digital nature ensures no risk of contamination or wear associated with physical components.
Does the system integrate with other orthopedic products?
Yes, the Trumatch Personalized Solutions system is designed to integrate with the ATTUNE Knee System for knee arthroplasty procedures. While it supports 3D anatomical assessment for shoulder arthroplasty, the integration with specific implant systems is limited to the ATTUNE Knee System as explicitly stated in its description.
What regulatory approval does the Trumatch Personalized Solutions system hold?
The system holds FDA 510K clearance under the reference number K110397, indicating it has been deemed substantially equivalent to a legally marketed predicate device. This clearance was granted by the FDA’s Orthopedic Devices Advisory Committee in 2011, confirming its compliance with regulatory requirements for surgical planning software in orthopedics.