Cleared Traditional

K121974 - CONFORMIS IUNI UNICONDYLAR KNEE REPLACE...

K121974 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 63-day FDA review.

K121974 · Conformis, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
63d
Days
Class 2
Risk

K121974 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 6, 2012 after a review of 63 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 K121974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date September 06, 2012
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
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

All 101
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K121974.
JOURNEY II Uni Tibial Base and Insert
K152315 · Smith & Nephew, Inc. · Oct 2015
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K132640 · Conformis, Inc. · Dec 2013
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
K122529 · Zimmer, Inc. · Nov 2012
HLS UNI EVOLUTION & U-KNEETEC
K120262 · Tornier, Inc. · Jul 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
K112301 · Materialise NV · Jan 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
K113038 · Smith & Nephew, Inc. · Jan 2012