Cleared Traditional

K905362 - BARBED SQUARE STAPLE

K905362 is an FDA 510(k) clearance for BARBED SQUARE STAPLE, manufactured by O'Tec Corp.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K905362 · O'Tec Corp. · Orthopedic device
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Dec 1990
Decision
13d
Days
Class 2
Risk

K905362 is an FDA 510(k) clearance for the BARBED SQUARE STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by O'Tec Corp. (Memphis, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K905362

510(k) Number K905362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1990
Decision Date December 11, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 122d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 131
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K905362.
BIODEGRADABLE SURGICAL STAPLE
K910723 · Instrument Makar, Inc. · Mar 1991
SNAP-PAK (TM)
K905112 · Mitek Surgical Products, Inc. · Jan 1991
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990
FIXATION STAPLE
K903022 · Onyx Medical Corp. · Aug 1990
ROUND STAPLE
K903271 · Onyx Medical Corp. · Jul 1990
BARBED SQUARE STAPLE
K903273 · Onyx Medical Corp. · Jul 1990