Patient Specific Distal Femoral

• • Ongoing Z-1778-2022 FDA Class II ·initiated 24 Aug 2022 ·on shared 510(k) K140898

  A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

• • 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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K140898 ↗

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

• Jts Extendible Distal Femoral Implant

  Class II

  FDA 510(k) K133152 Active Cleared 22 Jan 2014

• 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 →

• What is the Patient Specific Distal Femoral device used for?

  The Patient Specific Distal Femoral is a knee prosthesis designed for orthopedic procedures as a replacement for the distal femoral component of the knee joint. It is a femorotibial constrained cemented metal/polymer device.

• Is the Patient Specific Distal Femoral device reusable or MRI safe?

  This device is supplied as a single-use implant and is not MRI safe. It should only be used once and then discarded according to medical waste disposal protocols.

• What sizes and models are available for the Patient Specific Distal Femoral?

  The device is available in various sizes as indicated by the multiple registration numbers provided. Each size is designed to accommodate different patient anatomies and surgical requirements.

• What is the regulatory status of the Patient Specific Distal Femoral device?

  The device is authorized under FDA 510(k) clearance with product code KRO and regulation number 888.3510. It has been determined to be substantially equivalent to predicate devices.