Jts Extendible Distal Femoral Implant

• • Terminated Z-3104-2017 FDA Class II ·initiated 4 Jul 2017

  Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.

510(k) Number

K133152 ↗

FDA Product Code

KRO

FDA applicant

Stanmore Implants Worldwide , Ltd.

Device Class

Class II

Regulation

21 CFR Part 888.3510

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Jts Extendeable Implant

  Class II

  FDA 510(k) K092138 Active Cleared 22 Mar 2011

• Patient Specific Distal Femoral Open recall

  Class II

  FDA 510(k) K140898 Active Cleared 20 Jan 2015

• Mets Modular Total Femur

  Class II

  FDA 510(k) K121055 Active Cleared 19 Sep 2012

• Mets Modular Proximal Femur

  Class II

  FDA 510(k) K121056 Active Cleared 20 Sep 2012

• Sculptor Robotic Guidance Arm (RGA)

  Class II

  FDA 510(k) K121765 Active Cleared 11 Jan 2013

• Mets Modular Distal Femur

  Class II

  FDA 510(k) K121029 Active Cleared 19 Sep 2012

See all devices from Stanmore Implants Worldwide Ltd →