Cleared Traditional

K061206 - ACUTE BONE SCREW

K061206 is an FDA 510(k) clearance for ACUTE BONE SCREW, manufactured by Acute Innovations, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K061206 · Acute Innovations, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
49d
Days
Class 2
Risk

K061206 is an FDA 510(k) clearance for the ACUTE BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Acute Innovations, LLC (Hillsboro, US). The FDA issued a Cleared decision on June 19, 2006 after a review of 49 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. 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 Acute Innovations, LLC devices

FDA 510(k) Submission Details - K061206

510(k) Number K061206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2006
Decision Date June 19, 2006
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 764
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K061206.
SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
K061621 · Synthes (Usa) · Jul 2006
ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
K061665 · Arthrex, Inc. · Jul 2006
KALIX II IMPLANT
K061765 · New Deal, S.A. · Jul 2006
MILAGRO INTERFERENCE SCREW
K060830 · Depuy Mitek, A Johnson & Johnson Company · Jun 2006
ULTRATINE TRANSBLEPH
K060248 · Coapt Systems, Inc. · Jun 2006
ULTRATINE FOREHEAD
K060249 · Coapt Systems, Inc. · Jun 2006