Cleared Special

K081351 - MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT

K081351 is an FDA 510(k) clearance for MODIFICATION TO JOURNEY UNICONDYLAR FEM..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Special 510(k) pathway after a 71-day FDA review.

K081351 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
71d
Days
Class 2
Risk

K081351 is an FDA 510(k) clearance for the MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 24, 2008 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - 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 - K081351

510(k) Number K081351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2008
Decision Date July 24, 2008
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

HSX Device Classification - Class 2, Special Controls

Product Code HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3520
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 - HSX Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

All 114
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K081351.
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K073175 · Smith & Nephew, Inc. · Dec 2007
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K073248 · Mako Surgical Corp. · Dec 2007
K081351 · MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
Download PDF FDA Summary Smith & Nephew, Inc.