Cleared Traditional

K905357 - CORTICAL BONE SCREW (EUROPEAN STYLE)

K905357 is an FDA 510(k) clearance for CORTICAL BONE SCREW (EUROPEAN STYLE), manufactured by O'Tec Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K905357 · O'Tec Corp. · Orthopedic device
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Jan 1991
Decision
37d
Days
Class 2
Risk

K905357 is an FDA 510(k) clearance for the CORTICAL BONE SCREW (EUROPEAN STYLE). Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on January 4, 1991 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all O'Tec Corp. devices

FDA 510(k) Submission Details - K905357

510(k) Number K905357 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 28, 1990
Decision Date January 04, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
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 681
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K905357.
HUENE FIXATION SCREW
K910193 · Acu Med, Inc. · Aug 1991
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991
CANCELLOUS SCREW
K903253 · Onyx Medical Corp. · Aug 1990
U.S. TYPE CRUCIATE SLOT BONE SCREW
K903254 · Onyx Medical Corp. · Aug 1990
CORTICAL BONE SCREW (EUROPEAN STYLE)
K903255 · Onyx Medical Corp. · Aug 1990