# K112900: SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Lima Corporate S.P.A.
- Decided: Jun 1, 2012 after 242 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010657: Copeland MB Resurfacing Humeral Heads, Biomet Manufacturing, Inc. (2001) Summary page 2.
- K051843: Copeland Eas Humeral Resurfacing Heads, Biomet, Inc. (2005) Summary page 2.
- K031971: Global Cap Resurfacing Replacement Shoulder, DePuy Orthopaedics, Inc. (2003) Summary page 2.
- K080990: Depuy Global C.AP. Cta Resurfacing Shoulder, DePuy Orthopaedics, Inc. (2008) Summary page 2.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 2.
- K981487: Depuy Global Shoulder Glenoid, DePuy Orthopaedics, Inc. (1998) Summary page 2.

## Indications for use
The SMR Resurfacing Shoulder Prosthesis system is indicated for partial or total primary shoulder replacement in patients where the humeral head and neck have sufficient bone stock to support the prosthesis. The Standard Resurfacing heads are indicated for partial or total shoulder replacement when the rotator cuff is intact or reconstructable. Specific indications include: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; * Post-traumatic osteoarthritis; * Rheumatoid arthritis. The CTA Resurfacing Heads are indicated for partial shoulder replacement in patients with rotator cuff tears and arthritis. Specific indications include: *Rotator cuff tear arthropathy. The humeral heads and stems are intended for uncemented use only. The glenoid components, used in total shoulder replacement, are intended for cemented use only.

Source page: https://510kreport.com/device/K112900
Methodology: https://510kreport.com/methodology