Cleared Traditional

K111916 - CONFORMIS IUNI UNICONDYLAR KNEE REPLACE...

K111916 is the FDA 510(k) clearance for CONFORMIS IUNI UNICONDYLAR KNEE REPLACE... by Conformis, Inc.. It is a Class 2 Orthopedic device (product code HSX) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K111916 · Conformis, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2011
Decision
85d
Days
Class 2
Risk

K111916 is an FDA 510(k) clearance for the CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT 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 29, 2011 after a review of 85 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

Submission Details

510(k) Number K111916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2011
Decision Date September 29, 2011
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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