Cleared Traditional

ULTRATINE TRANSBLEPH (K060248) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060248 · Coapt Systems, Inc. · Orthopedic device
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Jun 2006
Decision
132d
Days
Class 2
Risk

K060248 is an FDA 510(k) clearance for the ULTRATINE TRANSBLEPH. 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

Submission Details

510(k) Number K060248 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.

Device Classification

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 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K060248.
ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES
K062679 · Arthrex, Inc. · Sep 2006
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
ARTHREX BIO-COMPRESSION SCREW
K060478 · Arthrex, Inc. · May 2006
UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS
K060710 · Zimmer, Inc. · Apr 2006
SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS
K060736 · Smith & Nephew, Inc. · Apr 2006