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510(k) K213387

AltiVate® Anatomic Shoulder AG e+™ with Markers by Encore Medical, L.P. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2022
Date Received
October 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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)
  • K251184 — AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIM (May 16, 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)

Other clearances for product code KWS

  • K252418 — Catalyst F1x Shoulder System (November 6, 2025)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K241292 — MyShoulder Planner (5.3SSWPL) (January 30, 2025)
  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)