Home / 510(k) Clearances / K081127

510(k) K081127

ACCIN TOTAL KNEE SYSTEM by Accelerated Innovation, LLC — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2008
Date Received
April 21, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Accelerated Innovation, LLC

  • K080647 — ACCIN BIPOLAR HEAD SYSTEM (July 8, 2008)
  • K080539 — ACCIN UNIPOLAR HEAD SYSTEM (June 2, 2008)
  • K073120 — ACCIN PATELLOFEMORAL SYSTEM (February 29, 2008)
  • K073531 — ACCIN PEDICLE SCREW SYSTEM (February 4, 2008)
  • K073530 — ACCIN ANTERIOR CERVICAL PLATE SYSTEM (January 31, 2008)
  • K073068 — ACCIN HIP SYSTEM (January 10, 2008)

Other clearances for product code JWH

  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 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)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)