# K143256: SMR Modular Glenoid

- Pathway: 510(k) (Special)
- Applicant: Lima Corporate S.P.A.
- Decided: May 28, 2015 after 196 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: 13 generations back to K911686 (1991). 90 ancestors in all.
No later device cites it as a predicate yet.
1 of 91 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws, Lima Corporate S.P.A. (2012) Summary page 5.
- K133349: SMR TT Metal Back Glenoid, Lima Corporate S.P.A. (2014) Summary page 5.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 5.

## Indications for use
The SMR Modular Glenoid and liner is intended for use in total primary or revision shoulder joint replacement with the SMR Anatomic Shoulder System. The SMR Anatomic Shoulder System is indicated for patients suffering from disability 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; • Revision of a failed primary implant; • Cuff tear arthropathy (CTA Heads only). The SMR Metal Backed Glenoid/Liner construct when used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.

Source page: https://510kreport.com/device/K143256
Methodology: https://510kreport.com/methodology