Cleared Traditional

K060249 - ULTRATINE FOREHEAD

K060249 is an FDA 510(k) clearance for ULTRATINE FOREHEAD, manufactured by Coapt Systems, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K060249 · Coapt Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
132d
Days
Class 2
Risk

K060249 is an FDA 510(k) clearance for the ULTRATINE FOREHEAD. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Coapt Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on June 12, 2006 after a review of 132 days - within the typical 510(k) review window.

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 Coapt Systems, Inc. devices

FDA 510(k) Submission Details - K060249

510(k) Number K060249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2006
Decision Date June 12, 2006
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 641
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K060249.
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
ARTHREX BIO-COMPRESSION SCREW
K060478 · Arthrex, Inc. · May 2006
SPIRALOK ANCHOR
K060271 · Depuy Mitek, A Johnson & Johnson Company · May 2006
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710 · Zimmer, Inc. · Apr 2006