# K153398: Comprehensive SRS/Nexel Elbow

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Feb 3, 2016 after 71 days
- Product code: JDC (Prosthesis, Elbow, Constrained, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K800494 (1980). 28 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111746: Comprehensive Segmental Revision System (SRS), Biomet, Inc. (2011) Summary page 4.

## Most influential descendants
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K223631: Comprehensive Segmental Revision System (SRS) (2023), 1 descendant of its own
- 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. 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/K153398
Methodology: https://510kreport.com/methodology