Cleared Traditional

K853267 - DAY STAPLE

K853267 is an FDA 510(k) clearance for DAY STAPLE, manufactured by Protek, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K853267 · Protek, Inc. · Orthopedic device
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Sep 1985
Decision
32d
Days
Class 2
Risk

K853267 is an FDA 510(k) clearance for the DAY STAPLE. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 32 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 Protek, Inc. devices

FDA 510(k) Submission Details - K853267

510(k) Number K853267 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 05, 1985
Decision Date September 06, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 122d · This submission: 32d
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 130
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K853267.
STAPLE FIXATION SYSTEM
K894929 · Concept, Inc. · Aug 1989
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988
KIRSCHNER BONE FIXATION FASTENER SYSTEM
K854445 · Kirschner Medical Corp. · Nov 1985
BONE STAPLING FIXATION SYS
K840566 · 3M Company · Nov 1984
FIXATION STAPLE DRIVER/EXTRACTOR
K832884 · Warsaw Orthopedic, Inc. · Oct 1983
STAPLES DESIGNED FOR ARTHROSCOPIC SURG
K830455 · Instrument Makar, Inc. · Mar 1983