Cleared Traditional

K073312 - OSTEOTRANS-OT SCREW

K073312 is an FDA 510(k) clearance for OSTEOTRANS-OT SCREW, manufactured by Takiron Co., Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K073312 · Takiron Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
172d
Days
Class 2
Risk

K073312 is an FDA 510(k) clearance for the OSTEOTRANS-OT SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Takiron Co., Ltd. (Chuo-Ku, Kobe, Hyogo, JP). The FDA issued a Cleared decision on May 13, 2008 after a review of 172 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. 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 Takiron Co., Ltd. devices

FDA 510(k) Submission Details - K073312

510(k) Number K073312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2007
Decision Date May 13, 2008
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
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 784
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K073312.
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SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · Synthes (Usa) · Apr 2008
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K080850 · Wrightmedicaltechnologyinc · Apr 2008