510(k) · Cleared
ClearedTornier Perform™ Reversed Monopost Glenoid (Perform Mono)
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 8, 2026 as substantially equivalent to K161742 (Tornier, Inc., 2016) and 3 other predicates after a 128-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Jan 8, 2026
- Review
- 128 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K911686 (1991). 119 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 1 generation backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- This deviceK252788 Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 7 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 6 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 5 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 4 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 1 generation backK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- This deviceK252788 Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −7 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −6 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −5 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −4 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −3 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −2 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| −1 | K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2018 | — |
| 0 (this device) | K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (4)
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 5…S I K211359 Shoulder iD Primary Reversed Glenoid PHX, KWS Glenoid IK161742 Aequalis Perform Reversed and Aequalis PerFORM+ Reversed PHX, KWS Predicate… | 2016 |
| * | K211359 | Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Summary page 5…PHX I K061439 IAequalis Reversed Prosthesis I PHX, KWS I K211359 Shoulder iD Primary Reversed Glenoid PHX, KWS… | 2021 |
| * | K061439 | Aequalis Reversed ProsthesisSummary page 5…21 CFR 807.92(a)(4) I K173900 Arthrex Univers Revers Modular Glenoid System PHX I K061439 IAequalis Reversed Prosthesis I PHX, KWS I K211359… | 2006 |
| * | K173900 | Arthrex Univers Revers Modular Glenoid SystemSummary page 5…replace the native glenoid surface of the IDevice Description Summary 21 CFR 807.92(a)(4) I K173900 Arthrex Univers Revers Modular Glenoid System PHX I K061439… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 22 of the 119 ancestors have a recall of any class.
- 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. 2026, 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 Tornier PerformTM Reversed MonoPost Glenoid implant is 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 glenohumeral joint if native glenoid bone remains
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/K252788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252788: Tornier Perform™ Reversed Monopost Glenoid (Perform Mono).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252788
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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