Cleared Traditional

K902567 - STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES

K902567 is an FDA 510(k) clearance for STAPLE, manufactured by A. Henniss. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K902567 · A. Henniss · Orthopedic device
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Jul 1990
Decision
29d
Days
Class 2
Risk

K902567 is an FDA 510(k) clearance for the STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by A. Henniss (Tarzana, US). The FDA issued a Cleared decision on July 10, 1990 after a review of 29 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 A. Henniss devices

FDA 510(k) Submission Details - K902567

510(k) Number K902567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1990
Decision Date July 10, 1990
Days to Decision 29 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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 200
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K902567.
ROUND STAPLE
K903271 · Onyx Medical Corp. · Jul 1990
BARBED SQUARE STAPLE
K903273 · Onyx Medical Corp. · Jul 1990
MITEK ANCHOR II
K902751 · Mitek Surgical Products, Inc. · Jul 1990
HTO COMPRESSING STAPLE
K895117 · Howmedica Corp. · May 1990
BONE SCREW
K893203 · Karlin Technology, Inc. · Apr 1990
MITEK ANCHOR(TM)
K897155 · Mitek Surgical Products, Inc. · Apr 1990