510(k) · Cleared
Recalled · 2009Encore Shoulder Revision Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Sep 30, 2008 after a 130-day review. The FDA summary names its predicate without a number. 32 later devices descend from it. It has been recalled once.
- Decided
- Sep 30, 2008
- Review
- 130 days
- Class
- Class II
- Product code
- MBF
- Recalls
- 1
- Predicates
- 0
32 later devices descend from it, 1 citing it directly.
- This deviceK081448 Encore Shoulder Revision GlenoidEncore Medical L.P. · 2008
- Descendant · cites it directly · 31 of its ownK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- Descendant · 2 generations on · 13 of its ownK153722 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016
- Descendant · 3 generations on · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
- Descendant · 3 generations on · 12 of its ownK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly31descendants
- K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · 2 generations on20descendants
- K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016 · 2 generations on13descendants
- K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · 3 generations on12descendants
- K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081448 | Encore Shoulder Revision Glenoid | Encore Medical L.P. | 2008 | — |
| +1 | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| +2 | K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016 | — |
| +3 | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
| +3 | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bio-Modular Shoulder System Named without a submission number |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws | 2012 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2009 | Not classified | Z-1992-2009 | Release of Material/Component prior to receiving test results | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113254 (Lima Corporate S.P.A., 2012) has gone furthest, with 31 descendants of its own.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081448 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081448: Encore Shoulder Revision Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081448
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026