Cleared Traditional

K994383 - DOGBONE ACFS

K994383 is an FDA 510(k) clearance for DOGBONE ACFS, manufactured by Theken Surgical. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K994383 · Theken Surgical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
38d
Days
Class 2
Risk

K994383 is an FDA 510(k) clearance for the DOGBONE ACFS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Theken Surgical (Barberton, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 38 days - a notably fast clearance 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: 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 Theken Surgical devices

FDA 510(k) Submission Details - K994383

510(k) Number K994383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1999
Decision Date February 04, 2000
Days to Decision 38 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 122d · This submission: 38d
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 527
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K994383.
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K000513 · Ebi, L.P. · Mar 2000
BONE GRAFT WASHER, MODEL 9090114 - 9090118
K994122 · Danek Medical, Inc. · Feb 2000
WILTSE SYSTEM
K992012 · Advanced Spine Fixation Systems, Inc. · Feb 2000
MODIFICATION TO ISOLA SPINAL SYSTEM
K993030 · Depuyacromed · Dec 1999
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM
K990959 · Spineology, Inc. · Dec 1999
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K993855 · Danek Medical, Inc. · Dec 1999