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510(k) K121029

METS MODULAR DISTAL FEMUR by Stanmore Implants Worldwide , Ltd. — Product Code KRO

K121029 is an FDA 510(k) premarket notification submitted by Stanmore Implants Worldwide , Ltd. for the device "METS MODULAR DISTAL FEMUR". The FDA issued a decision of Substantially Equivalent on September 19, 2012. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Stanmore Implants Worldwide , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2012
Date Received
April 5, 2012
Clearance Type
Traditional
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)
  • K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (January 22, 2014)
  • 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)
  • K120992 — METS SMILES TOTAL KNEE REPLACEMENT (September 5, 2012)
  • K092138 — JTS EXTENDEABLE IMPLANT (March 22, 2011)

Other clearances for product code KRO

  • K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (August 6, 2026)
  • 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)

FDA data resources