Cleared Traditional

K943725 - UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM

K943725 is an FDA 510(k) clearance for UNIVERSAL SPINAL ROD AND SCREW FIXATION..., manufactured by Synthes Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 389-day FDA review.

K943725 · Synthes Spine · Orthopedic device
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Aug 1995
Decision
389d
Days
Class 2
Risk

K943725 is an FDA 510(k) clearance for the UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Synthes Spine (Paoli, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 389 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Synthes Spine devices

FDA 510(k) Submission Details - K943725

510(k) Number K943725 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 01, 1994
Decision Date August 25, 1995
Days to Decision 389 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
267d slower than avg
Panel avg: 122d · This submission: 389d
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 613
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K943725.
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
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · Synthes (Usa) · Jul 1995
ISOLA ANTERIOR SYSTEM
K943819 · Acromed Corp. · Feb 1995
EBI ANTERIOR CERVICAL SPINE SYSTEM
K943694 · Electro-Biology, Inc. · Feb 1995