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510(k) K183077

Delta Xtend Reverse Shoulder System by Depuy(Ireland) — Product Code PHX

K183077 is an FDA 510(k) premarket notification submitted by Depuy(Ireland) for the device "Delta Xtend Reverse Shoulder System". The FDA issued a decision of Substantially Equivalent on May 17, 2019. The device falls under product code PHX (Shoulder Prosthesis, Reverse Configuration), a Class II device regulated under 21 CFR 888.3660. Depuy(Ireland) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2019
Date Received
November 5, 2018
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)

  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K192855 — DELTA XTEND(TM) Reverse Shoulder System (February 24, 2020)
  • 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)
  • 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

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

FDA data resources