Cleared Traditional

K060670 - ACCIN UNI-KNEE SYSTEM

K060670 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 Traditional 510(k) pathway after a 80-day FDA review.

K060670 · Accin Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
80d
Days
Class 2
Risk

K060670 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 June 2, 2006 after a review of 80 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 Accin Corporation devices

FDA 510(k) Submission Details - K060670

510(k) Number K060670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date June 02, 2006
Days to Decision 80 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 122d · This submission: 80d
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 110
Devices cleared under the same product code (HSX) and FDA review panel - the closest regulatory comparables to K060670.
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
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
K060017 · Mako Surgical Corp. · Feb 2006
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
K050373 · Arthrosurface, Inc. · Oct 2005
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
K043570 · Conformis, Inc. · Mar 2005