Cleared Traditional

K072586 - CONFORMIS UNI-CONDYLAR KNEE SYSTEM

K072586 is an FDA 510(k) clearance for CONFORMIS UNI-CONDYLAR KNEE SYSTEM, 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 56-day FDA review.

K072586 · Conformis, Inc. · Orthopedic device
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Nov 2007
Decision
56d
Days
Class 2
Risk

K072586 is an FDA 510(k) clearance for the CONFORMIS UNI-CONDYLAR KNEE 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 November 8, 2007 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conformis, Inc. devices

FDA 510(k) Submission Details - K072586

510(k) Number K072586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2007
Decision Date November 08, 2007
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
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 109
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K072586.
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
CONFORMIS METAL BACKED TIBIAL COMPONENT
K072368 · Conformis, Inc. · Sep 2007
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
K063432 · Conformis, Inc. · Mar 2007
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006