Cleared Traditional

K953779 - SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM

K953779 is an FDA 510(k) clearance for SADDLE WITH ANCHOR, manufactured by Advanced Spine Fixation Systems, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K953779 · Advanced Spine Fixation Systems, Inc. · Orthopedic device
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Nov 1995
Decision
85d
Days
Class 2
Risk

K953779 is an FDA 510(k) clearance for the SADDLE WITH ANCHOR, STAINLESS STEEL VARIFIX SYSTEM. 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 November 7, 1995 after a review of 85 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

FDA 510(k) Submission Details - K953779

510(k) Number K953779 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 14, 1995
Decision Date November 07, 1995
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

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 208
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K953779.
AUGMENT-T POSTERIOR SPINAL SYSTEM
K950717 · Sofamor Danek USA,Inc. · Feb 1996
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
K950999 · Buckman Co., Inc. · Jan 1996
ISOLA SYSTEM
K952236 · Acromed Corp. · Jan 1996
SADDLE WITH ANCHOR, TITANIUM VARIFIX SYSTEM
K953778 · Advanced Spine Fixation Systems, Inc. · Nov 1995
TITANIUM DYNA-LOK SPINAL SYSTEM
K953635 · Sofamor Danek USA,Inc. · Oct 1995
OSTEONICS SPINAL SYSTEM
K951725 · Osteonics Corp. · Sep 1995