Cleared Special

K081351 - MODIFICATION TO JOURNEY UNICONDYLAR FEM...

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

K081351 · Smith & Nephew, Inc. · Orthopedic device
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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.

View all Smith & Nephew, Inc. devices

Submission Details

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.

Device Classification

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 99
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K081351.
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K082081 · Mako Surgical Corp. · Oct 2008
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
K080368 · Mako Surgical Corp. · Jun 2008
JOURNEY UNICONDYLAR FEMORAL IMPLANT
K073175 · Smith & Nephew, Inc. · Dec 2007
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K073248 · Mako Surgical Corp. · Dec 2007