Cleared Special

K093078 - UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS

K093078 is an FDA 510(k) clearance for UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS, 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 266-day FDA review.

K093078 · Bonutti Research, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
266d
Days
Class 2
Risk

K093078 is an FDA 510(k) clearance for the UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS. 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 June 23, 2010 after a review of 266 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. 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. Standard predicate reliance. 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 - K093078

510(k) Number K093078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date June 23, 2010
Days to Decision 266 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
144d slower than avg
Panel avg: 122d · This submission: 266d
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 1053
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K093078.
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165 · Wrightmedicaltechnologyinc · Jul 2010
NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM
K101254 · Tecnologia Y Diseno Industrial, S.A DE C.V · Jul 2010
DARCO HEADED CANNULATED SCREW
K100359 · Wrightmedicaltechnologyinc · Jun 2010
MODIFICATION TO HBS HEADLESS BONE SCREW
K101030 · Biopro, Inc. · Jun 2010
SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
K093820 · Memometal Technologies · May 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · Smith & Nephew, Inc. · May 2010
K093078 · UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS
Download PDF FDA Summary Bonutti Research, Inc.