Cleared Traditional

WEBB-MORLEY SPINE SYSTEM (K960451) - FDA 510(k) Clearance

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

K960451 · Buckman Co., Inc. · Orthopedic device
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Apr 1996
Decision
79d
Days
Class 2
Risk

K960451 is an FDA 510(k) clearance for the WEBB-MORLEY SPINE SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 79 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K960451 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 30, 1996
Decision Date April 18, 1996
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 122d · This submission: 79d
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 K960451.
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE
K963357 · Synthes (Usa) · Jan 1997
SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR
K962608 · Synthes (Usa) · Dec 1996
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