Cleared Traditional

K950209 - J.B.S. ANTERIOR SPINE SYSTEM(R)

K950209 is an FDA 510(k) clearance for J.B.S. ANTERIOR SPINE SYSTEM, manufactured by J.B.S. (Usa), Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K950209 · J.B.S. (Usa), Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
265d
Days
Class 2
Risk

K950209 is an FDA 510(k) clearance for the J.B.S. ANTERIOR SPINE SYSTEM(R). Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by J.B.S. (Usa), Inc. (Foster City, US). The FDA issued a Cleared decision on October 11, 1995 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 J.B.S. (Usa), Inc. devices

FDA 510(k) Submission Details - K950209

510(k) Number K950209 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 19, 1995
Decision Date October 11, 1995
Days to Decision 265 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K950209.
SOFAMOR, LAURAIN DEWALD ANTERIOR FIXATION
K940744 · Sofamor Co. · Jan 1996
CODMAN ANTERIOR CERVICAL PLATE SYSTEM
K953730 · Johnson & Johnson Professionals, Inc. · Nov 1995
AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION
K953720 · Aesculap, Inc. · Nov 1995
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K943725 · Synthes Spine · Aug 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
ISOLA ANTERIOR SYSTEM
K943819 · Acromed Corp. · Feb 1995