510(k) · Cleared
ClearedARROW Anatomical Porous glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Apr 10, 2017 as substantially equivalent to K093599 (Fournitures Hospitalieres Industrie, 2010) and 3 other predicates after a 258-day review. Its family tree reaches back 13 generations to 1991. 4 later devices descend from it.
- Decided
- Apr 10, 2017
- Review
- 258 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K911686 (1991). 81 ancestors in all, the oldest K790987 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 2 generations backK103251 Duocentric ReversedAston Medical · 2011
- 1 generation backK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
- This deviceK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
- Descendant · cites it directly · 3 of its ownK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
- Descendant · 2 generations on · 1 of its ownK242253 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
- Descendant · 3 generations on · 0 of its ownK252411 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
- Descendant · 2 generations on · 0 of its ownK232226 ARROW Off-Centred Humeral InsertFH Industrie · 2023
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 6 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 5 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 4 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 3 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 2 generations backK103251 Duocentric ReversedAston Medical · 2011
- 1 generation backK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
- This deviceK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
Most influential descendants
Showing 4 of 4 · See all- K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018 · cites it directly3descendants
- K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024 · 2 generations on1descendant
- K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025 · 3 generations on0descendants
- K232226ARROW Off-Centred Humeral InsertFH Industrie · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −6 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −5 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −4 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −3 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −2 | K103251 | Duocentric Reversed | Aston Medical | 2011 | — |
| −1 | K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | 2015 | — |
| 0 (this device) | K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017 | — |
| +1 | K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | 2018 | — |
| +2 | K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024 | — |
| +3 | K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025 | — |
| +2 | 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 | 3 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 MBF? 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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 |
|---|---|---|---|
| * | K093599 | Arrow Anatomical Shoulder SystemSummary page 5…Manufacturer: Fournitures Hospitalières Industrie Device Trade Name: ARROW Anatomical Shoulder System 510 (K): K093599 Manufacturer: Fournitures Hospitalières Industrie Device Trade Name: ARROW Reverse Shoulder… | 2010 |
| * | K112193 | Arrow Reverse Shoulder SystemSummary page 5…Manufacturer: Fournitures Hospitalières Industrie Device Trade Name: ARROW Reverse Shoulder System 510 (K): K112193 Manufacturer: Fournitures Hospitalières Industrie Device Trade Name: ARROW Reverse Shoulder… | 2012 |
| * | K142778 | ARROW Reverse Shoulder long keel and short keel glenoid baseSummary page 5…rie Device Trade Name: ARROW Reverse Shoulder long keel and short keel glenoid base 510 (K): K142778 Manufacturer: Biomet Orthopedics Device Trade Name: Bio-Modular Shoulder System 510… | 2015 |
| * | K030710 | Bio-Modular Shoulder SystemSummary page 5…K142778 Manufacturer: Biomet Orthopedics Device Trade Name: Bio-Modular Shoulder System 510 (K): K030710 5. Device description The ARROW anatomical porous glenoid consists of a glenoid insert and a porous glenoid base. The porou… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171789 | ARROW Reverse Porous Glenoid | 2018 | 3 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 81 ancestors have a recall of any class.
- Of its descendants, K171789 (Fournitures Hospitalieres Industrie, 2018) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K093599.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR:
- CENTRED GLENOHUMERAL OSTEOARTHRITIS
- RHEUMATOID POLYARTHRITIS
- POST-TRAUMATIC SEQUELA WITH GLENOID INJURY
- FRACTURES OF THE PROXIMAL HUMERUS WITH GLENOID INJURY
- REVISION FOR GLENOID LOOSENING
- GLENOID BONE LOSS, WHERE BONE GRAFT IS NEEDED
A FUNCTIONAL ROTATOR CUFF IS NECESSARY TO USE THIS DEVICE
THE POROUS GLENOID BASE 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/K162068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162068: ARROW Anatomical Porous glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162068
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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