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510(k) K171789

ARROW Reverse Porous Glenoid by Fournitures Hospitalieres Industrie — Product Code PHX

K171789 is an FDA 510(k) premarket notification submitted by Fournitures Hospitalieres Industrie for the device "ARROW Reverse Porous Glenoid". The FDA issued a decision of Substantially Equivalent on Jan 23, 2018. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Fournitures Hospitalieres Industrie has 23 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 23, 2018
Date Received
Jun 15, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Prosthesis, Reverse Configuration
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type
510(k)

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

Other clearances by Fournitures Hospitalieres Industrie

  • K163148 — BePOD® Foot Screws (Sep 14, 2017)
  • K163710 — BePOD® EZ Weil Screws (Sep 8, 2017)
  • K162068 — ARROW Anatomical Porous glenoid (Apr 10, 2017)
  • K170040 — BePOD Cannulated Arthrodesis Screws (Apr 4, 2017)
  • K150568 — ARROW Humeral stems size 6 and 16 (Oct 29, 2015)
  • K150471 — CalcaNail Orthopedic Arthrodesis Nail (May 22, 2015)
  • K150463 — CalcaNail Orthopedic Nail (May 22, 2015)
  • K142778 — ARROW Reverse Shoulder long keel and short keel glenoid base (Mar 20, 2015)
  • K120740 — COLS® FIXATION SYSTEM (Mar 5, 2013)
  • K112193 — ARROW REVERSE SHOULDER SYSTEM (Jul 12, 2012)

Other clearances for product code PHX

  • K260556 — Veritas Shoulder System (Jul 1, 2026)
  • K261683 — Augment Off-Axis Instrument System (Jun 16, 2026)
  • K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid… (Jun 12, 2026)
  • K261016 — MSS - Humeral reverse liners extension (Jun 10, 2026)
  • K253992 — Veritas Reverse Total Shoulder System (May 7, 2026)
  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (Apr 15, 2026)
  • K260583 — Equinoxe® Shoulder System (Apr 14, 2026)
  • K254128 — InSet Reverse Total Shoulder System (Apr 13, 2026)
  • K253674 — Blueprint Patient-Specific Instrumentation (Apr 3, 2026)
  • K253624 — INHANCE™ Reverse Shoulder System (Mar 11, 2026)

FDA data resources