Home / 510(k) Clearances / K251184

510(k) K251184

AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System by Encore Medical, L.P. — Product Code PHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2025
Date Received
April 16, 2025
Clearance Type
Special
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 Encore Medical, L.P.

  • K252567 — AltiVate Reverse® ADLC Glenosphere (January 15, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K252141 — AltiVate Reverse® Glenoid (August 5, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K241483 — ceramys™ femoral head system (February 7, 2025)
  • K233481 — AltiVate Reverse® Glenoid (May 29, 2024)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K213387 — AltiVate® Anatomic Shoulder AG e+™ with Markers (July 7, 2022)

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)