510(k) · Cleared
ClearedArrow Anatomical Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Nov 24, 2010 as substantially equivalent to K984541 (DePuy Orthopaedics, Inc., 1999) and 3 other predicates after a 369-day review. Its family tree reaches back 5 generations to 1991. 11 later devices descend from it.
- Decided
- Nov 24, 2010
- Review
- 369 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K911686 (1991). 29 ancestors in all, the oldest K790987 (1979). 11 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
- 1 generation backK061454 Exactech Equinoxe Shoulder StemsExactech, Inc. · 2006
- This deviceK093599 Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie · 2010
- Descendant · cites it directly · 10 of its ownK112193 Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012
- Descendant · 2 generations on · 5 of its ownK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
- Descendant · cites it directly · 4 of its ownK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
- Descendant · cites it directly · 4 of its ownK150568 ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015
- Descendant · 2 generations on · 3 of its ownK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie · 2012 · cites it directly10descendants
- K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015 · 2 generations on5descendants
- K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017 · cites it directly4descendants
- K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie · 2015 · cites it directly4descendants
- K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K042021 | Exactech Equinoxe Shoulder System | Exactech, Inc. | 2004 | 10 |
| −1 | K061454 | Exactech Equinoxe Shoulder Stems | Exactech, Inc. | 2006 | — |
| 0 (this device) | K093599 | Arrow Anatomical Shoulder System | Fournitures Hospitalieres Industrie | 2010 | — |
| +1 | K112193 | Arrow Reverse Shoulder System | Fournitures Hospitalieres Industrie | 2012 | — |
| +2 | K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | 2015 | — |
| +1 | K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017 | — |
| +1 | K150568 | ARROW Humeral stems size 6 and 16 | Fournitures Hospitalieres Industrie | 2015 | — |
| +2 | K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | 1999 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 1…er: DePuy Orthopaedics, Inc Device Trade Name: Globa]T 'Advantage Shoulder 5 10 (K): K98454 I/ K992065 Foumnitures Hospitalieres industrie ARROW 0 anatomical shoulder system… | 1999 |
| * | K042021 | Exactech Equinoxe Shoulder SystemSummary page 2…Manufacturer. Exactech, Inc. Device Trade Name: Exactech Equinoxem Shoulder System 510 (K): K042021/ K061454 5.-S. Device Description: The ARROW 0 anatomical shoulder system is a modular shoulder prosthesis, composed of the foll… | 2004 |
| * | K061454 | Exactech Equinoxe Shoulder StemsSummary page 2…anufacturer. Exactech, Inc. Device Trade Name: Exactech Equinoxem Shoulder System 510 (K): K042021/ K061454 5.-S. Device Description: The ARROW 0 anatomical shoulder system is a modular shoulder prosthesis, composed of the following ele… | 2006 |
What descends from it? (11)
See all 115 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 19 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K112193 (Fournitures Hospitalieres Industrie, 2012) has gone furthest, with 10 descendants of its own.
- 9 other devices also cite its predicate K984541.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The ARROW anatomical shoulder system, depending on the components used, is 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 - Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis…
Read the full statement (119 words)
The ARROW anatomical shoulder system, depending on the components used, is 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
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 1200.
Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
- Centered gleniohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093599: Arrow Anatomical Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093599
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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