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510(k) K192855

DELTA XTEND(TM) Reverse Shoulder System by Depuy(Ireland) — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2020
Date Received
October 4, 2019
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 Depuy(Ireland)

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  • K190344 — DePuy Corail AMT Hip Prosthesis (November 1, 2019)
  • K191779 — Attune Revision LPS Inserts (October 8, 2019)
  • K192448 — Delta Xtend Revers Shoulder System (October 4, 2019)
  • K183077 — Delta Xtend Reverse Shoulder System (May 17, 2019)
  • K170806 — ATTUNE Cemented Tibial Base, Fixed Bearing (June 15, 2017)
  • K160907 — DePuy Actis DuoFix Hip Prosthesis (July 19, 2016)
  • K160700 — ATTUNE Revision Knee System (June 10, 2016)
  • K140881 — DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS (February 13, 2015)
  • K133834 — DEPUY GLOBAL UNITE SHOULDER SYSTEM (April 3, 2014)

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)
  • K252516 — N22 EZ Glenosphere (January 15, 2026)
  • K252567 — AltiVate Reverse® ADLC 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)