Cleared Special

K140900 - PATIENT SPECIFIC SMILES TOTAL KNEE REPL...

K140900 is an FDA 510(k) clearance for PATIENT SPECIFIC SMILES TOTAL KNEE REPL..., manufactured by Stanmore Worldwide Implants , Ltd.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Special 510(k) pathway after a 310-day FDA review.

K140900 · Stanmore Worldwide Implants , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
310d
Days
Class 2
Risk

K140900 is an FDA 510(k) clearance for the PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Stanmore Worldwide Implants , Ltd. (Plymouth, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Worldwide Implants , Ltd. devices

FDA 510(k) Submission Details - K140900

510(k) Number K140900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2014
Decision Date February 12, 2015
Days to Decision 310 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
188d slower than avg
Panel avg: 122d · This submission: 310d
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 72
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