Cleared Traditional

K062820 - UNITY ALPHA SYSTEM

K062820 is an FDA 510(k) clearance for UNITY ALPHA SYSTEM, manufactured by Bonutti Research, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K062820 · Bonutti Research, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
176d
Days
Class 2
Risk

K062820 is an FDA 510(k) clearance for the UNITY ALPHA SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on March 15, 2007 after a review of 176 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bonutti Research, Inc. devices

FDA 510(k) Submission Details - K062820

510(k) Number K062820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2006
Decision Date March 15, 2007
Days to Decision 176 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
54d slower than avg
Panel avg: 122d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 735
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K062820.
ASNIS MICRO CANNULATED SCREW
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CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER
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OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
K063298 · Osteomed LP · Mar 2007
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K063478 · Depuy Mitek, A Johnson & Johnson Company · Dec 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
K063070 · Cayenne Medical, Inc. · Dec 2006