510(k) · Cleared
ClearedARROW Humeral stems size 6 and 16
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 29, 2015 as substantially equivalent to K093599 (Fournitures Hospitalieres Industrie, 2010) and 5 other predicates after a 237-day review. Its family tree reaches back 11 generations to 1991. 4 later devices descend from it.
- Decided
- Oct 29, 2015
- Review
- 237 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K911686 (1991). 62 ancestors in all, the oldest K790987 (1979). 4 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 2 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 1 generation backK112193 Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012
- This deviceK150568 ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015
- Descendant · cites it directly · 2 of its ownK202024 ARROW Short Stem Humeral SystemFH Industrie · 2021
- Descendant · cites it directly · 1 of its ownK253345 JARVIS Diaphyseal Stem StandardFH Industrie · 2025
- Descendant · 2 generations on · 0 of its ownK254003 JARVIS Metaphyseal StemFH Industrie · 2026
- Descendant · cites it directly · 0 of its ownK232226 ARROW Off-Centred Humeral InsertFH Industrie · 2023
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 4 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 3 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 2 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 1 generation backK112193 Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012
- This deviceK150568 ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015
Most influential descendants
Showing 4 of 4 · See all- K202024ARROW Short Stem Humeral SystemFH Industrie · 2021 · cites it directly2descendants
- K253345JARVIS Diaphyseal Stem StandardFH Industrie · 2025 · cites it directly1descendant
- K254003JARVIS Metaphyseal StemFH Industrie · 2026 · 2 generations on0descendants
- K232226ARROW Off-Centred Humeral InsertFH Industrie · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −4 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −3 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −2 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −1 | K112193 | Arrow Reverse Shoulder System | Fournitures Hospitalieres Industrie | 2012 | — |
| 0 (this device) | K150568 | ARROW Humeral stems size 6 and 16 | Fournitures Hospitalieres Industrie | 2015 | — |
| +1 | K202024 | ARROW Short Stem Humeral System | FH Industrie | 2021 | — |
| +1 | K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025 | — |
| +2 | K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026 | — |
| +1 | K232226 | ARROW Off-Centred Humeral Insert | FH Industrie | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (6)
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 |
|---|---|---|---|
| * | K093599 | Arrow Anatomical Shoulder SystemSummary page 3…evices are designed to articulate with ARROW“ anatomical shoulder system cleared in K093599 and ARROW“ reverse shoulder system cleared in K112193. Indications for Use:… | 2010 |
| * | K112193 | Arrow Reverse Shoulder SystemSummary page 3…al shoulder system cleared in K093599 and ARROW“ reverse shoulder system cleared in K112193. Indications for Use: ARROW£ Humeral stems size 6 and 16, depending on the… | 2012 |
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 5…Exactech, Inc. Device Trade Name: Exactech Equinoxe® Shoulder System 510 (K): K042021 / K061454 Manufacturer: Exactech, Inc. Device Trade Name:… | 2004 |
| * | K061454 | Exactech Equinoxe Shoulder StemsSummary page 5…Exactech, Inc. Device Trade Name: Exactech Equinoxe® Shoulder System 510 (K): K042021 / K061454 Manufacturer: Exactech, Inc. Device Trade Name: Exactec… | 2006 |
| * | K063569 | Equinoxe Reverse Shoulder SystemSummary page 5…Trade Name: Exactech Equinoxe® Reverse Shoulder System 510 (K): K063569 / K073688 5-5. Device Description: The ARROW Humeral stems are composed of two stems size 6… | 2007 |
| * | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewSummary page 5…: Exactech Equinoxe® Reverse Shoulder System 510 (K): K063569 / K073688 5-5. Device Description: The ARROW Humeral stems are composed of two stems size 6 and 16. Th… | 2008 |
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)
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 24 years and passes through 6 companies; a new generation was cleared every 1.0 years on median.
- 17 of the 62 ancestors have a recall of any class.
- Of its descendants, K202024 (FH Industrie, 2021) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K093599.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for: SIMPLE HUMERAL PROSTHESIS: - Fracture dislocation or complex four part fracture of the proximal humerus - Humeral head necrosis without injury to the glenoid cavity. - Extensive humeral head cartilage damage without injury to the glenoid cavity - Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis…
Read the full statement (198 words)
ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for:
SIMPLE HUMERAL PROSTHESIS:
- Fracture dislocation or complex four part fracture of the proximal humerus
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS):
- Centred glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
REVERSE PROSTHESIS:
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150568 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150568: ARROW Humeral stems size 6 and 16.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150568
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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