Cleared Traditional

K853033 - HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM

K853033 is an FDA 510(k) clearance for HARTSHILL RECT & WIRES, manufactured by A.W. Showell (Surgicraft) , Ltd.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K853033 · A.W. Showell (Surgicraft) , Ltd. · Orthopedic device
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Sep 1985
Decision
68d
Days
Class 2
Risk

K853033 is an FDA 510(k) clearance for the HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by A.W. Showell (Surgicraft) , Ltd. (Worcs. B97 6hf England, GB). The FDA issued a Cleared decision on September 24, 1985 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.W. Showell (Surgicraft) , Ltd. devices

FDA 510(k) Submission Details - K853033

510(k) Number K853033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1985
Decision Date September 24, 1985
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 122d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 614
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K853033.
SIMMONS PLATING SYSTEM
K910681 · Smith & Nephew Richards, Inc. · Oct 1991
CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.)
K904446 · Acromed Corp. · Sep 1991
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · Acromed Corp. · Nov 1988
OEC/REZAIAN SPINAL FIXATOR
K841189 · Orthopedic Equipment Co., Inc. · May 1984
BRADFORD SPINAL FRACTURE FIXATION SYS
K831982 · Depuy, Inc. · Sep 1983
ANTERIOR KYPHOSIS DISTRACTION DEVICE
K802222 · Zimmer, Inc. · Oct 1980