510(k) · Cleared
Recalled · Class II · 2025Aequalis PerFORM Reversed, 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 Nov 15, 2016 as substantially equivalent to K081059 (Tornier, 2008) after a 144-day review. Its family tree reaches back 9 generations to 1991. 53 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 15, 2016
- Review
- 144 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K911686 (1991). 27 ancestors in all, the oldest K800494 (1980). 53 later devices descend from it, 21 citing it directly.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 2 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 1 generation backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- This deviceK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016
- Descendant · cites it directly · 12 of its ownK191746 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019
- Descendant · cites it directly · 11 of its ownK200171 SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020
- Descendant · cites it directly · 8 of its ownK211359 Tornier Perform™ Patient-Matched Primary Reversed Glenoid and…Tornier, Inc. · 2021 · Recalled
- Descendant · cites it directly · 8 of its ownK210717 Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021
- Descendant · 2 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 5 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 2 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 1 generation backK081059 Aequalis Reversed Shoulder ProsthesisTornier · 2008
- This deviceK161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. · 2016
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2019 · cites it directly12descendants
- K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A. · 2020 · cites it directly11descendants
- K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc. · 2021 · cites it directly8descendants
- K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A. · 2021 · cites it directly8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −5 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −2 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −1 | K081059 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2008 | — |
| 0 (this device) | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid | Tornier, Inc. | 2016 | — |
| +1 | K191746 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2019 | — |
| +1 | K200171 | SMR TT Augmented Glenoid System | Lima Corporate S.P.A. | 2020 | — |
| +1 | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™… | Tornier, Inc. | 2021 | 2 |
| +1 | K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | 2021 | — |
| +2 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
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 |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 8 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K081059 | Aequalis Reversed Shoulder ProsthesisSummary page 4…Class II Primary Product Code: PHX Secondary Product Code: KWS III. Predicate Device Information Primary Predicate: Aequalis Reversed Shoulder Prosthesis, K081059 Reference Device: Zimmer Trabecular Metal Reverse, K052906 Reference Device: Exactech Equinoxe Reversed Augmented, K1… | 2008 |
| † | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | 2005 |
| † | K110708 | Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior… | 2011 |
What descends from it? (53)
See all 5321 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191746 | SMR TT Augmented Glenoid System | 2019 | 12 |
| K200171 | SMR TT Augmented Glenoid System | 2020 | 11 |
| K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient… | 2021 | 8 |
| K210717 | Bone Screws dia. 5,0 mm | 2021 | 8 |
| K220847 | AETOS Shoulder System | 2023 | 5 |
| K213459 | Glenoid Reconstruction System | 2022 | 5 |
| K233481 | AltiVate Reverse® Glenoid | 2024 | 4 |
| K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | 2023 | 4 |
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | 2019 | 4 |
| K222427 | PRIMA TT Glenoid | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2025 | Class II | Z-1237-2026 | Labeling mix-ups | A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw… |
| Sep 15, 2023 | Class II | Z-0113-2024 | Process change control | One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate. |
| May 3, 2022 | Class II | Z-1216-2022 | Device Design | The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K191746 (Lima Corporate S.P.A., 2019) has gone furthest, with 12 descendants of its own.
- 8 other devices also cite its predicate K081059.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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/K161742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161742: Aequalis PerFORM Reversed, 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/K161742
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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