Cleared Traditional

K073311 - OSTEOTRANS-OT PIN

K073311 is an FDA 510(k) clearance for OSTEOTRANS-OT PIN, manufactured by Takiron Co., Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K073311 · 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

K073311 is an FDA 510(k) clearance for the OSTEOTRANS-OT PIN. Classified as Pin, Fixation, Smooth (product code HTY), 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 - K073311

510(k) Number K073311 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.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 124
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K073311.
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · Biopro, Inc. · Mar 2009
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · OrthoPediatrics Corp. · Oct 2008
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561 · Teleflex Medical · May 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 2007
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · Arthrex, Inc. · Nov 2005