Cleared Special

K140898 - PATIENT SPECIFIC DISTAL FEMORAL

K140898 is the FDA 510(k) clearance for PATIENT SPECIFIC DISTAL FEMORAL by Stanmore Implants Worldwide , Ltd.. It is a Class 2 Orthopedic device (product code KRO) cleared through the Special 510(k) pathway after a 287-day FDA review.

K140898 · Stanmore Implants Worldwide , Ltd. · Orthopedic device
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Jan 2015
Decision
287d
Days
Class 2
Risk

K140898 is an FDA 510(k) clearance for the PATIENT SPECIFIC DISTAL FEMORAL. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Stanmore Implants Worldwide , Ltd. (Plymouth, US). The FDA issued a Cleared decision on January 20, 2015 after a review of 287 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stanmore Implants Worldwide , Ltd. devices

Submission Details

510(k) Number K140898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2014
Decision Date January 20, 2015
Days to Decision 287 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 122d · This submission: 287d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 69
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