# K131112: Limacorporate SMR Cta Humeral Heads

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: Jun 7, 2013 after 46 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K873073 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110847: SMR Shoulder System - Cta Humeral Heads, Lima Corporate S.P.A. (2011) Summary page 1.

## Indications for use
The SMR CTA Humeral Heads are intended for use with cemented and uncemented SMR humeral body — humeral stem assemblies in total or hemi- shoulder joint arthroplasty. The glenoid is intended for cemented use only. Total and hemi-shoulder replacement utilizing the CTA head is indicated for patients suffering from dnsablllty due to: . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; . Inflammatory.degenerative joint disease such as rheumatoid arthritis; * Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; * Cuff tear arthropathy.

Source page: https://510kreport.com/device/K131112
Methodology: https://510kreport.com/methodology