Cleared Traditional

K061385 - OSSTAPLE

K061385 is an FDA 510(k) clearance for OSSTAPLE, manufactured by Biomedical Enterprises, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K061385 · Biomedical Enterprises, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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May 2007
Decision
377d
Days
Class 2
Risk

K061385 is an FDA 510(k) clearance for the OSSTAPLE, OSSPLATE, OSSFORCE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Biomedical Enterprises, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 30, 2007 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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. Elevated predicate reliance profile. 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 Biomedical Enterprises, Inc. devices

FDA 510(k) Submission Details - K061385

510(k) Number K061385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2006
Decision Date May 30, 2007
Days to Decision 377 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
255d slower than avg
Panel avg: 122d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 491
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