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510(k) K112193

ARROW REVERSE SHOULDER SYSTEM by Fournitures Hospitalieres Industrie — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2012
Date Received
July 29, 2011
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

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

  • K171789 — ARROW Reverse Porous Glenoid (January 23, 2018)
  • K163148 — BePOD® Foot Screws (September 14, 2017)
  • K163710 — BePOD® EZ Weil Screws (September 8, 2017)
  • K162068 — ARROW Anatomical Porous glenoid (April 10, 2017)
  • K170040 — BePOD Cannulated Arthrodesis Screws (April 4, 2017)
  • K150568 — ARROW Humeral stems size 6 and 16 (October 29, 2015)
  • K150463 — CalcaNail Orthopedic Nail (May 22, 2015)
  • K150471 — CalcaNail Orthopedic Arthrodesis Nail (May 22, 2015)
  • K142778 — ARROW Reverse Shoulder long keel and short keel glenoid base (March 20, 2015)
  • K120740 — COLS® FIXATION SYSTEM (March 5, 2013)

Other clearances for product code PHX

  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)
  • K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
  • K252516 — N22 EZ Glenosphere (January 15, 2026)
  • K254003 — JARVIS Metaphyseal Stem (January 9, 2026)
  • K252788 — Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) (January 8, 2026)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K253345 — JARVIS Diaphyseal Stem Standard (October 29, 2025)
  • K252221 — Inset Reverse Total Shoulder System (September 26, 2025)