Cleared Traditional

FIXATION STAPLE (K905363) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905363 · O'Tec Corp. · Orthopedic device
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Dec 1990
Decision
13d
Days
Class 2
Risk

K905363 is an FDA 510(k) clearance for the FIXATION 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

Submission Details

510(k) Number K905363 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.

Device Classification

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 66
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K905363.
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990
HTO COMPRESSING STAPLE
K895117 · Howmedica Corp. · May 1990
BONE STAPLING FIXATION SYS
K840566 · 3M Company · Nov 1984
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943 · Howmedica Corp. · Oct 1982