Cleared Special

K140898 - PATIENT SPECIFIC DISTAL FEMORAL

K140898 is an FDA 510(k) clearance for PATIENT SPECIFIC DISTAL FEMORAL, 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 287-day FDA review.

K140898 · 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 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.

FDA 510(k) Submission Details - K140898

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 122d · This submission: 287d
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 K140898.
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
K140900 · Stanmore Worldwide Implants , Ltd. · Feb 2015
Zimmer Segmental System XT Components
K150028 · Zimmer, Inc. · Feb 2015
The LINK® Endo-Model® Knee System
K143179 · Waldemar Link GmbH & Co. KG · Jan 2015
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
K140509 · Biomet Manufacturing, LLC · May 2014
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
K133152 · Stanmore Implants Worldwide , Ltd. · Jan 2014
MAK OSS FEMORAL KNEE COMPONENTS
K131393 · Biomet Orthopedics Corp. · Oct 2013
K140898 · PATIENT SPECIFIC DISTAL FEMORAL
Download PDF FDA Summary Stanmore Implants Wor…