Cleared Traditional

K854524 - KIRSCHNER SPINAL PRODUCT SYSTEM

K854524 is an FDA 510(k) clearance for KIRSCHNER SPINAL PRODUCT SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K854524 · Kirschner Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
27d
Days
Class 2
Risk

K854524 is an FDA 510(k) clearance for the KIRSCHNER SPINAL PRODUCT SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K854524

510(k) Number K854524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date December 09, 1985
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 282
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K854524.
ROGOZINSKI SPINAL SYSTEM
K884263 · Richards Medical Co., Inc. · Dec 1988
LUMBAR IMPACTION SET
K875290 · T. Korossurgical Instruments Corp. · Mar 1988
ACROMED CROSS ROD CONNECTOR
K874882 · Acromed Corp. · Feb 1988
EDWARDS SACRAL SCREW
K851935 · Zimmer, Inc. · Jun 1985
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · Depuy, Inc. · Apr 1981
ARMSTRONG SPINAL APPLIANCE
K810224 · Howmedica Corp. · Feb 1981