Cleared Traditional

K973868 - SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)

K973868 is the FDA 510(k) clearance for SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) by Osteotech, Inc.. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973868 · Osteotech, Inc. · Orthopedic device
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Jan 1998
Decision
90d
Days
Class 2
Risk

K973868 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 January 8, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteotech, Inc. devices

Submission Details

510(k) Number K973868 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 10, 1997
Decision Date January 08, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K973868.
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
K980928 · Synthes Spine · May 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · Synthes (Usa) · Apr 1998
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K974573 · Depuy, Inc. · Feb 1998
CD SPINAL SYSTEM
K964159 · Sofamor Danek USA,Inc. · Oct 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · Smith & Nephew Richards, Inc. · May 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · Sofamor Danek USA,Inc. · Apr 1997