# K223631: Comprehensive Segmental Revision System (SRS)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics
- Decided: Jul 12, 2023 after 219 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K800494 (1980). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173411: Comprehensive Segmental Revision System (SRS), Biomet Manufacturing Corp (2018) Summary page 5.

## Most influential descendants
- K251686: Tornier Humeral Reconstruction System Max (Tornier HRS Max) (2025), 0 descendants of its own

## Indications for use
The Comprehensive® Segmental Revision System is intended for use in cases of: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Revision where other devices or treatments have failed. 3. Correction of functional deformity. 4. Oncology applications including bone loss due to tumor resection. When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods. When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for: Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods. Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement. The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder. The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral and total humeral applications. Tissue Attachment Augments provide the option for tissue stabilization and attachment. Tissue Attachment Augments are not available in all markets.

Source page: https://510kreport.com/device/K223631
Methodology: https://510kreport.com/methodology