Cleared Traditional

K010466 - TETHER ACFS

K010466 is an FDA 510(k) clearance for TETHER ACFS, manufactured by Theken Surgical,Llc. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K010466 · Theken Surgical,Llc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
89d
Days
Class 2
Risk

K010466 is an FDA 510(k) clearance for the TETHER ACFS. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Theken Surgical,Llc (Barberton, US). The FDA issued a Cleared decision on May 16, 2001 after a review of 89 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,Llc devices

FDA 510(k) Submission Details - K010466

510(k) Number K010466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2001
Decision Date May 16, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 512
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K010466.
CODMAN SLIM-LOC SYSTEM
K013877 · Codman & Shurtleff, Inc. · Dec 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · Aesculap, Inc. · Nov 2001
MACROPORE OS SPINAL SYSTEM
K010911 · Macropore Biosurgery, Inc. · Jul 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · Aesculap, Inc. · May 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · Howmedica Osteonics Corp. · Apr 2001
EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K010003 · Ebi, L.P. · Jan 2001