510(k) · Cleared
ClearedINHANCETM Shoulder System – Humeral Stems and Stemless
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Dec 2, 2022 as substantially equivalent to K212737 (Depuy Ireland UC, 2022) and 2 other predicates after a 46-day review. Its family tree reaches back 16 generations to 1991. 1 of the 204 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 2, 2022
- Review
- 46 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K911686 (1991). 203 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 204 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations between
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- 1 generation backK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- This deviceK223211 INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC · 2022
Show all 16 generations
- Root · 16 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 15 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 14 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 13 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 12 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 11 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 9 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 8 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 7 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 6 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 5 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 4 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 3 generations backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
- 2 generations backK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- 1 generation backK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- This deviceK223211 INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC · 2022
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −15 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −14 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −12 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −11 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −9 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −8 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −7 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −6 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −5 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −4 | K112615 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −3 | K122698 | Aequalis Ascend Flex Shoulder System | Tornier S.A.S. | 2013 | 2 |
| −2 | K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| −1 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| 0 (this device) | K223211 | INHANCETM Shoulder System – Humeral Stems and Stemless | Depuy Ireland UC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 10 | 0 |
| 2005 | 10 | 0 |
| 2006 | 13 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K212737 | INHANCE™ Reverse Shoulder SystemSummary page 6…lic uncemented prosthesis (21 CFR §888.3690); Class II Product Codes: PHX, MBF, KWT, KWS, PKC, PAO, HSD Predicate Device: K212737 – (Primary) INHANCE Reverse Shoulder System, DePuy Ireland UC K202716 – INHAN… | 2022 |
| * | K202716 | Ignite Anatomic Shoulder SystemSummary page 6…KWS, PKC, PAO, HSD Predicate Device: K212737 – (Primary) INHANCE Reverse Shoulder System, DePuy Ireland UC K202716 – INHANCE Anatomic Shoulder System; DePuy Ireland UC (formerly Ignite Anatomic Shoulder System; Ignite… | 2021 |
| * | K203108 | Ignite Stemless Anatomic Shoulder SystemSummary page 6…INHANCE Anatomic Shoulder System; DePuy Ireland UC (formerly Ignite Anatomic Shoulder System; Ignite Orthopedics LLC) K203108 – INHANCE Stemless Anatomic Shoulder System; DePuy Ireland UC (formerly Ignite Stemless Anatomic Should… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
- 56 of the 203 ancestors have a recall of any class; 1 has a Class I recall.
- 6 other devices also cite its predicate K212737.
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?
Anatomic Total Shoulder or Hemi-Shoulder The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following: » Osteoarthritis » Post-traumatic arthrosis » Focal avascular necrosis of the humeral head * Previous surgeries of the shoulder that do not compromise the fixation The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or…
Read the full statement (337 words)
Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
» Osteoarthritis
» Post-traumatic arthrosis
» Focal avascular necrosis of the humeral head
* Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
» Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis.
» Revision where other devices or treatments have failed.
* Correction of functional deformity.
* Fractures of the humeral head (with Short Humeral Stems)
* Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
* Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
* A severely painful, disabling, arthritic joint
* Fractures of the humeral head (with Short Humeral Stems)
* Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
* Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw 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/K223211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223211: INHANCETM Shoulder System – Humeral Stems and Stemless.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223211
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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