510(k) · Cleared
ClearedTornier Perform Humeral System – Fracture
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 Oct 14, 2022 as substantially equivalent to K131231 (Tornier S.A.S., 2013) after a 198-day review. Its family tree reaches back 12 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 14, 2022
- Review
- 198 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K911686 (1991). 49 ancestors in all, the oldest K800494 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 2 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 1 generation backK131231 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2013
- This deviceK220914 Tornier Perform Humeral System – FractureTornier, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK240876 Identity Shoulder SystemZimmer, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253592 Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral…Zimmer, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 5 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 4 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 3 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 2 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 1 generation backK131231 Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2013
- This deviceK220914 Tornier Perform Humeral System – FractureTornier, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −5 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −4 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −3 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −2 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −1 | K131231 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis… | Tornier S.A.S. | 2013 | — |
| 0 (this device) | K220914 | Tornier Perform Humeral System – Fracture | Tornier, Inc. | 2022 | — |
| +1 | K240876 | Identity Shoulder System | Zimmer, Inc. | 2024 | — |
| +2 | K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity… | Zimmer, Inc. | 2026 | — |
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 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131231 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Summary page 5…PAO Predicate Device Information Primary Predicate: Aequalis Reversed Fracture Shoulder Prosthesis and Aequalis Shoulder Fracture System, K131231 Reference Device: Humelock Reversed Shoulder, K162455 Reference Device: Perform Humeral System – Stem, K201315 Devi… | 2013 |
| † | K162455 | Humelock Reversed Shoulder | 2017 |
| † | K201315 | PERFORM Humeral System – Stem | 2020 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240876 | Identity Shoulder System | 2024 | 1 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 49 ancestors have a recall of any class.
- Of its descendants, K240876 (Zimmer, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K131231.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
In Anatomic: The Tornier Perform® Humeral System — Fracture combined with a humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement. The Tornier Perform Humeral System — Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and…
Read the full statement (415 words)
In Anatomic:
The Tornier Perform® Humeral System — Fracture combined with a humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The Tornier Perform Humeral System — Fracture is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain.
The Tornier Perform Humeral System — Fracture is indicated for use as a replacement of shoulder joints disabled by:
* Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
* Fracture sequelae
* Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
All components are single use. The fracture stems are intended for cemented or cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. In a total shoulder arthroplasty, the Tornier Perform Humeral System — Fracture is intended to be used with cemented polyethylene glenoid components.
In Reverse:
The Tornier Perform Humeral System — Fracture combined with a reverse insert is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by:
* Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures
* Proximal humerus bone defect
* Fracture sequelae
* Revisions where adequate fixation can be achieved and adequate bone stock remains after final reconstruction
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed fracture stem for patients with a functional deltoid muscle.
All components are single use. The fracture stems are intended for cemented or cementless use. In cementless use, the fracture stems are intended for use with or without cortical screws. The Tornier Perform Humeral System — Fracture is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220914: Tornier Perform Humeral System – Fracture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220914
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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