Home / 510(k) Clearances / K122395

510(k) K122395

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS by DePuy Orthopaedics, Inc. — Product Code HSN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2012
Date Received
August 7, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3110
Review Panel
OR
Submission Type

Other clearances by DePuy Orthopaedics, Inc.

  • K231503 — CUPTIMIZE™ Advanced (August 22, 2023)
  • K213839 — DePuy Corail AMT Hip Prosthesis (January 6, 2022)
  • K210167 — DELTA XTEND Reverse Shoulder System (February 19, 2021)
  • K203167 — DePuy Corail AMT Hip Prosthesis (November 19, 2020)
  • K202472 — ACTIS Duofix Hip Prosthesis (October 21, 2020)
  • K201347 — DePuy ATTUNE™ Total Knee System (June 18, 2020)
  • K193540 — TRUMATCH Personalized Solutions (June 16, 2020)
  • K193398 — Summit DuoFix HA Coating (February 4, 2020)
  • K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis (November 26, 2019)
  • K192946 — DePuy Corail AMT Hip Prosthesis (November 26, 2019)

Other clearances for product code HSN

  • K252454 — Kinos Total Ankle System (September 3, 2025)
  • K250037 — Incompass Total Ankle System (June 20, 2025)
  • K250641 — APEX 3D Total Ankle Replacement System (May 1, 2025)
  • K240475 — Hintermann Series H2 Total Ankle System (December 2, 2024)
  • K241999 — Prophecy Surgical Planning System (November 1, 2024)
  • K242868 — Kinos Total Ankle System (October 18, 2024)
  • K241482 — Kinos Total Ankle System (July 22, 2024)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)
  • K240591 — restor3d Kinos Axiom Total Ankle System (April 29, 2024)
  • K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System (April 23, 2024)