# K111746: Comprehensive Segmental Revision System (SRS)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 15, 2011 after 177 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K800494 (1980). 27 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043505: Discovery-Mosaic Total Humerus System, Biomet, Inc. (2005) Summary page 2.
- K042321: Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral Head, Biomet Manufacturing Corp (2005) Summary page 2.
- K033280: Discovery Elbow-Mosaic Distal Humeral Replacement System, Biomet, Inc. (2003) Summary page 1.
- K020045: 3-Piece Proximal Humeral Replacement System, Biomet Orthopedics, Inc. (2002) Summary page 2.
- K022079: Short and Long Soft Tissue Attachment, Biomet, Inc. (2002) Summary page 2.
- K925613: Proximal Humeral Replacement System, Biomet, Inc. (1994) Summary page 2.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 1.
- K051975: Porous Coated Discovery Elbow, Biomet, Inc. (2005) Summary page 2.

## Most influential descendants
- K143659: Equinoxe Mega Prosthesis (2015), 5 descendants of its own
- K153398: Comprehensive SRS/Nexel Elbow (2016), 3 descendants of its own
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own
- K162903: Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies (2017), 1 descendant of its own

## Recalls of this device
- Feb 28, 2018 · Class II · Z-1173-2018: During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humera

## 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. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. 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. 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.

Source page: https://510kreport.com/device/K111746
Methodology: https://510kreport.com/methodology