510(k) · Cleared
Recalled · Class II · 2025AltiVate Reverse® Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on May 29, 2024 as substantially equivalent to K041066 (Encore Medical L.P., 2005) and 4 other predicates after a 216-day review. Its family tree reaches back 10 generations to 1991. 4 later devices descend from it. It has been recalled 8 times.
- Decided
- May 29, 2024
- Review
- 216 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 8
- Predicates
- 5
Its longest line of descent runs back 10 generations to K911686 (1991). 36 ancestors in all, the oldest K800494 (1980). 4 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations between
- 3 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 2 generations backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- 1 generation backK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
- This deviceK233481 AltiVate Reverse® GlenoidEncore Medical L.P. · 2024
- Descendant · cites it directly · 0 of its ownK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK252567 AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026
- Descendant · cites it directly · 0 of its ownK252141 AltiVate Reverse® GlenoidEncore Medical L.P. · 2025
- Descendant · cites it directly · 0 of its ownK251184 AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder…Encore Medical L.P. · 2025
Show all 10 generations
- Root · 10 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 8 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 7 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 6 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 3 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 2 generations backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- 1 generation backK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016 · Recalled
- This deviceK233481 AltiVate Reverse® GlenoidEncore Medical L.P. · 2024
Most influential descendants
Showing 4 of 4 · See all- K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc. · 2026 · cites it directly0descendants
- K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026 · cites it directly0descendants
- K252141AltiVate Reverse® GlenoidEncore Medical L.P. · 2025 · cites it directly0descendants
- K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −9 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −6 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −3 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −2 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| −1 | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016 | 3 |
| 0 (this device) | K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2024 | — |
| +1 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity… | Zimmer, Inc. | 2026 | — |
| +1 | K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026 | — |
| +1 | K252141 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2025 | — |
| +1 | K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System… | Encore Medical L.P. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 PHX? 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 5…antial equivalence of the subject AltiVate Reverse® Glenoid is being claimed with the primary predicate device, Encore Reverse Shoulder Prosthesis® (RSP) Glenoid System (K041066, K051075, K092873, and K112069), and the additional predicate Tornier Perform Reversed Augmented Glenoid (K161742). This predica… | 2005 |
| * | K051075 | Encore Reverse Shoulder ProsthesisSummary page 5…uivalence of the subject AltiVate Reverse® Glenoid is being claimed with the primary predicate device, Encore Reverse Shoulder Prosthesis® (RSP) Glenoid System (K041066, K051075, K092873, and K112069), and the additional predicate Tornier Perform Reversed Augmented Glenoid (K161742). This predicates have… | 2005 |
| * | K092873 | Reverse Shoulder ProsthesisSummary page 5…of the subject AltiVate Reverse® Glenoid is being claimed with the primary predicate device, Encore Reverse Shoulder Prosthesis® (RSP) Glenoid System (K041066, K051075, K092873, and K112069), and the additional predicate Tornier Perform Reversed Augmented Glenoid (K161742). This predicates have not been… | 2009 |
| * | K112069 | RSP Glenoid Baseplate Porous CoatedSummary page 5…ct AltiVate Reverse® Glenoid is being claimed with the primary predicate device, Encore Reverse Shoulder Prosthesis® (RSP) Glenoid System (K041066, K051075, K092873, and K112069), and the additional predicate Tornier Perform Reversed Augmented Glenoid (K161742). This predicates have not been subject to a… | 2011 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 5…core Reverse Shoulder Prosthesis® (RSP) Glenoid System (K041066, K051075, K092873, and K112069), and the additional predicate Tornier Perform Reversed Augmented Glenoid (K161742). This predicates have not been subject to a design‐related recall. Reference devices: SMR Reverse Liner (K220792) IV. DEVICE… | 2016 |
| † | K220792 | SMR Reverse Liner | 2022 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral… | 2026 | 0 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | 2026 | 0 |
| K252141 | AltiVate Reverse® Glenoid | 2025 | 0 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2025 | Class II | Z-2548-2025 | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| Jul 18, 2025 | Class II | Z-2546-2025 | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| Jul 18, 2025 | Class II | Z-2549-2025 | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| Jul 18, 2025 | Class II | Z-2547-2025 | Device Design | Their is a potential that the reamer may kick or bind up during or immediately prior to use. |
| May 28, 2025 | Class II | Z-2011-2025 | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. |
| May 28, 2025 | Class II | Z-2010-2025 | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. |
| May 28, 2025 | Class II | Z-2008-2025 | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. |
| May 28, 2025 | Class II | Z-2009-2025 | Process control | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 36 ancestors have a recall of any class.
- Of its descendants, K253592 (Zimmer, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 24 other devices also cite its predicate K041066.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral…
Read the full statement (157 words)
The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
Severe arthropathy with a grossly deficient rotator cuff;
Previously failed joint replacement with a grossly deficient rotator cuff;
Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
Bone defect in proximal humerus;
Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
Inflammatory arthritis including rheumatoid arthritis;
Correction of functional deformity.
The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.
All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233481: AltiVate Reverse® Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233481
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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