Cleared Special

K133152 - JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

K133152 is an FDA 510(k) clearance for JTS EXTENDIBLE DISTAL FEMORAL IMPLANT, manufactured by Stanmore Implants Worldwide , Ltd.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Special 510(k) pathway after a 61-day FDA review.

K133152 · Stanmore Implants Worldwide , Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
61d
Days
Class 2
Risk

K133152 is an FDA 510(k) clearance for the JTS EXTENDIBLE DISTAL FEMORAL IMPLANT. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Stanmore Implants Worldwide , Ltd. (Washington, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133152

510(k) Number K133152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2013
Decision Date January 22, 2014
Days to Decision 61 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 86
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K133152.
The LINK® Endo-Model® Knee System
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K131393 · Biomet Orthopedics Corp. · Oct 2013
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DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
K122015 · Howmedica Osteonics Corp. · Feb 2013
K133152 · JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Download PDF FDA Summary Stanmore Implants Wor…