Cleared Special

K082906 - UNITY BETA ANCHOR SYSTEM

K082906 is an FDA 510(k) clearance for UNITY BETA ANCHOR SYSTEM, manufactured by Bonutti Research, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 30-day FDA review.

K082906 · Bonutti Research, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
30d
Days
Class 2
Risk

K082906 is an FDA 510(k) clearance for the UNITY BETA ANCHOR 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 October 30, 2008 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

View all Bonutti Research, Inc. devices

FDA 510(k) Submission Details - K082906

510(k) Number K082906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date October 30, 2008
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K082906.
MAXTORQUE MINI CANNULATED SCREW SYSTEM
K082574 · Orthohelix Surgical Designs, Inc. · Dec 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · OrthoPediatrics Corp. · Nov 2008
DARCO SMALL SCREW
K082320 · Wrightmedicaltechnologyinc · Nov 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · Arthrocare Corp. · Oct 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · Smith & Nephew, Inc. · Sep 2008
EXTREMITY MEDICAL COMPRESSION SCREW
K081934 · Extremity Medical, LLC · Aug 2008