Cleared Traditional

STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW (K953369) - FDA 510(k) Clearance

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

K953369 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Sep 1995
Decision
52d
Days
Class 2
Risk

K953369 is an FDA 510(k) clearance for the STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Advanced Spine Fixation Systems, Inc. (Cypress, US). The FDA issued a Cleared decision on September 8, 1995 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Advanced Spine Fixation Systems, Inc. devices

Submission Details

510(k) Number K953369 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 18, 1995
Decision Date September 08, 1995
Days to Decision 52 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 39
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K953369.
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · Wrightmedicaltechnologyinc · Sep 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · Depuy, Inc. · Feb 1996
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM
K951626 · Synthes (Usa) · Aug 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · Synthes (Usa) · Aug 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074 · Wrightmedicaltechnologyinc · Aug 1995