# K081448: Encore Shoulder Revision Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Sep 30, 2008 after 130 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Modular Shoulder System: named in the summary without a submission number

## Most influential descendants
- K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws (2012), 31 descendants of its own
- K133349: SMR TT Metal Back Glenoid (2014), 20 descendants of its own
- K153722: SMR 3-Pegs Glenoids (2016), 13 descendants of its own
- K191746: SMR TT Augmented Glenoid System (2019), 12 descendants of its own
- K163397: SMR Hybrid Glenoid System (2017), 12 descendants of its own

## Recalls of this device
- Jul 20, 2009 · Not classified · Z-1992-2009: Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.

## Indications for use
The Gemini Revision Glenoid is indicated for un-cemented use for the following indications: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable (e.g. revision of a failed primary component); cuff tear arthropathy. Uncemented fixation may be supplemented by optional screw fixation.

Source page: https://510kreport.com/device/K081448
Methodology: https://510kreport.com/methodology