510(k) · Cleared
Recalled · Class II · 2024Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jan 30, 2019 as substantially equivalent to K161742 (Tornier, Inc., 2016) after a 30-day review. Its family tree reaches back 10 generations to 1991. 4 later devices descend from it. It has been recalled once.
- Decided
- Jan 30, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K911686 (1991). 28 ancestors in all, the oldest K800494 (1980). 4 later devices descend from it, 3 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 deviceK183696 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK210790 Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK260102 Tornier Perform Reversed Glenoid and Tornier Perform Reversed…Stryker Corporation (Tornier, Inc.) · 2026
- Descendant · 2 generations on · 0 of its ownK240278 Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK203694 DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC · 2021
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 deviceK183696 Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2021 · cites it directly1descendant
- K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.) · 2026 · cites it directly0descendants
- K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc. · 2024 · 2 generations on0descendants
- K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC · 2021 · 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) | K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | Tornier, Inc. | 2019 | — |
| +1 | K210790 | Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2021 | — |
| +1 | K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented… | Stryker Corporation (Tornier, Inc.) | 2026 | — |
| +2 | K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2024 | — |
| +1 | K203694 | DELTA XTEND Reverse Shoulder System | Depuy Ireland UC | 2021 | — |
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 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 4…Predicate Device Information Predicate: Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid 510(k) Number: K161742 Device Description The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modula… | 2016 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2024 | Class II | Z-0773-2024 | Packaging process control | The incorrect device is contained in the labeled package. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K210790 (Fx Shoulder USA, Inc., 2021) has gone furthest, with 1 descendant of its own.
- 20 other devices also cite its predicate K161742.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Aequalis™ PerFORM™ Reversed & Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:
• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of the devices if sufficient bone stock remains
Notes:
• All components are single use.
• The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183696: Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183696
Report an extraction error
Are you the manufacturer?
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