Cleared Traditional

SPINE-TECH CERVICAL FIXATION SYSTEM (K931653) - FDA 510(k) Clearance

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

K931653 · Spinal Technologies · Orthopedic device
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Aug 1994
Decision
486d
Days
Class 2
Risk

K931653 is an FDA 510(k) clearance for the SPINE-TECH CERVICAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Spinal Technologies (Minneapolis, US). The FDA issued a Cleared decision on August 4, 1994 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Spinal Technologies devices

Submission Details

510(k) Number K931653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1993
Decision Date August 04, 1994
Days to Decision 486 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
364d slower than avg
Panel avg: 122d · This submission: 486d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 242
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K931653.
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM
K934756 · Codman & Shurtleff, Inc. · Nov 1994
CASPAR TITANIUM ALLOY BONE SCREWS
K936269 · Aesculap, Inc. · Aug 1994
SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE
K925351 · Synthes (Usa) · Nov 1993
SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE
K926453 · Synthes (Usa) · Oct 1993
SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS
K922855 · Synthes (Usa) · Jun 1993