Cleared Traditional

K063432 - CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)

K063432 is an FDA 510(k) clearance for CONFORMIS METAL BACKED TIBIAL COMPONENT..., manufactured by Conformis, Inc.. The device is a Class 2 Orthopedic device with product code HSX cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K063432 · Conformis, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2007
Decision
123d
Days
Class 2
Risk

K063432 is an FDA 510(k) clearance for the CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT). Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Conformis, Inc. (Foster City, US). The FDA issued a Cleared decision on March 16, 2007 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3520 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Conformis, Inc. devices

FDA 510(k) Submission Details - K063432

510(k) Number K063432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date March 16, 2007
Days to Decision 123 days
Submission Type Traditional
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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 113
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K063432.
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K073248 · Mako Surgical Corp. · Dec 2007
CONFORMIS UNI-CONDYLAR KNEE SYSTEM
K072586 · Conformis, Inc. · Nov 2007
CONFORMIS METAL BACKED TIBIAL COMPONENT
K072368 · Conformis, Inc. · Sep 2007
ACCIN UNI-KNEE SYSTEM
K063782 · Accin Corporation · Jan 2007
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · Smith & Nephew, Inc. · Jul 2006