Cleared Traditional

K043570 - UNICONDYLAR KNEE REPAIR SYSTEM / CONFOR...

K043570 is an FDA 510(k) clearance for UNICONDYLAR KNEE REPAIR SYSTEM / CONFOR..., 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 77-day FDA review.

K043570 · Conformis, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2005
Decision
77d
Days
Class 2
Risk

K043570 is an FDA 510(k) clearance for the UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD. 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 14, 2005 after a review of 77 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 - K043570

510(k) Number K043570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date March 14, 2005
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K043570.
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · Smith & Nephew, Inc. · Jul 2006
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · Mako Surgical Corp. · Feb 2006
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · Howmedica Osteonics Corp. · Feb 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · Zimmer, Inc. · Jan 2004
STELKAST UNICONDYLAR KNEE SYSTEM
K032824 · Stelkast Company · Nov 2003