Home / 510(k) Clearances / K133152

510(k) K133152

JTS EXTENDIBLE DISTAL FEMORAL IMPLANT by Stanmore Implants Worldwide , Ltd. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2014
Date Received
November 22, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

Other clearances by Stanmore Implants Worldwide , Ltd.

  • K140898 — PATIENT SPECIFIC DISTAL FEMORAL (January 20, 2015)
  • K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA) (January 11, 2013)
  • K121056 — METS MODULAR PROXIMAL FEMUR (September 20, 2012)
  • K121055 — METS MODULAR TOTAL FEMUR (September 19, 2012)
  • K121029 — METS MODULAR DISTAL FEMUR (September 19, 2012)
  • K120992 — METS SMILES TOTAL KNEE REPLACEMENT (September 5, 2012)
  • K092138 — JTS EXTENDEABLE IMPLANT (March 22, 2011)

Other clearances for product code KRO

  • K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patell (December 15, 2025)
  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation S (March 21, 2024)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (May 19, 2023)
  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)
  • K223528 — Triathlon® Hinge Knee System (January 20, 2023)