Cleared Special

K063782 - ACCIN UNI-KNEE SYSTEM

K063782 is an FDA 510(k) clearance for ACCIN UNI-KNEE SYSTEM, manufactured by Accin Corporation. The device is a Class 2 Orthopedic device with product code HSX cleared through the Special 510(k) pathway after a 29-day FDA review.

K063782 · Accin Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
29d
Days
Class 2
Risk

K063782 is an FDA 510(k) clearance for the ACCIN UNI-KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (product code HSX), Class II - Special Controls.

Submitted by Accin Corporation (Clifton, US). The FDA issued a Cleared decision on January 19, 2007 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063782

510(k) Number K063782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2006
Decision Date January 19, 2007
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 114
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K063782.
CONFORMIS UNI-CONDYLAR KNEE SYSTEM
K072586 · Conformis, Inc. · Nov 2007
CONFORMIS METAL BACKED TIBIAL COMPONENT
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CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
K063432 · Conformis, Inc. · Mar 2007
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
K061779 · Smith & Nephew, Inc. · Aug 2006
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
K061011 · Smith & Nephew, Inc. · Jul 2006
ACCIN UNI-KNEE SYSTEM
K060670 · Accin Corporation · Jun 2006
K063782 · ACCIN UNI-KNEE SYSTEM
Download PDF FDA Summary Accin Corporation