Cleared Traditional

K955927 - BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)

K955927 is an FDA 510(k) clearance for BRYAN POSTERIOR SPINAL FIXATOR (MODIFIC..., manufactured by Arcan Orthopaedic Corp.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K955927 · Arcan Orthopaedic Corp. · Orthopedic device
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Mar 1996
Decision
82d
Days
Class 2
Risk

K955927 is an FDA 510(k) clearance for the BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION). Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Arcan Orthopaedic Corp. (Ogden, US). The FDA issued a Cleared decision on March 13, 1996 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Arcan Orthopaedic Corp. devices

FDA 510(k) Submission Details - K955927

510(k) Number K955927 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 22, 1995
Decision Date March 13, 1996
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 374
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K955927.
COTREL-DUBOUSSET (CD) SPINAL
K955807 · Sofamor Danek USA,Inc. · Oct 1996
COMPACT COTREL-DUBOUSSET (CCD) SPINAL SYSTEM
K955365 · Sofamor Danek USA,Inc. · Mar 1996
J.B. S. C1-C2 CLAMP
K955864 · J.B.S., S.A. · Mar 1996
ROGOZINSKI THORACOLUMBAR SPINAL ROD
K954696 · Smith & Nephew Richards, Inc. · Mar 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · Depuy, Inc. · Feb 1996
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
K951846 · Alphatec Mfg., Inc. · Feb 1996