Cleared Special

K092441 - MODIFICATION TO: CONFORMIS IUNI UNICOND...

K092441 is the FDA 510(k) clearance for MODIFICATION TO: CONFORMIS IUNI UNICOND... by Conformis, Inc.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Special 510(k) pathway after a 30-day FDA review.

K092441 · Conformis, Inc. · Orthopedic device
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Sep 2009
Decision
30d
Days
Class 2
Risk

K092441 is an FDA 510(k) clearance for the MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Conformis, Inc. (Burlington, US). The FDA issued a Cleared decision on September 9, 2009 after a review of 30 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 Conformis, Inc. devices

Submission Details

510(k) Number K092441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2009
Decision Date September 09, 2009
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K092441.
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K111916 · Conformis, Inc. · Sep 2011
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
K102069 · Smith & Nephew, Inc. · Oct 2010
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K100197 · Smith & Nephew, Inc. · Feb 2010
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
K082081 · Mako Surgical Corp. · Oct 2008
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
K081351 · Smith & Nephew, Inc. · Jul 2008
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
K080368 · Mako Surgical Corp. · Jun 2008