Cleared Traditional

K955173 - SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

K955173 is an FDA 510(k) clearance for SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM), manufactured by Osteotech, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K955173 · Osteotech, Inc. · Orthopedic device
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Feb 1996
Decision
88d
Days
Class 2
Risk

K955173 is an FDA 510(k) clearance for the SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM). Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 88 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K955173

510(k) Number K955173 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 13, 1995
Decision Date February 09, 1996
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 377
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K955173.
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · Depuy, Inc. · Feb 1996
MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS
K951846 · Alphatec Mfg., Inc. · Feb 1996
CD LIBERTY POSTERIOR SPINCAL SYSTEM
K951164 · Sofamor Danek USA,Inc. · Feb 1996
CENTRA-LINE GRAPPLE, VARIFIX SYSTEM
K954770 · Advanced Spine Fixation Systems, Inc. · Jan 1996
TITANIUM GDLH POSTERIOR SPINAL SYSTEM
K954645 · Sofamor Danek USA,Inc. · Jan 1996
SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
K936294 · Sofamor Danek Mfg., Inc. · Dec 1995