Cleared Traditional

K983622 - BODYFORM THORACO-LUMBAR FIXATION SYSTEM

K983622 is an FDA 510(k) clearance for BODYFORM THORACO-LUMBAR FIXATION SYSTEM, 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 76-day FDA review.

K983622 · Theken Surgical,Llc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
76d
Days
Class 2
Risk

K983622 is an FDA 510(k) clearance for the BODYFORM THORACO-LUMBAR FIXATION SYSTEM. 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 December 30, 1998 after a review of 76 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 - K983622

510(k) Number K983622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1998
Decision Date December 30, 1998
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
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 511
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K983622.
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · Spinal Concepts, Inc. · Feb 1999
MICOMED - HALM ZIELKE INSTRUMENTATION
K982006 · Micomed GmbH · Jan 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · Danek Medical, Inc. · Jan 1999
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · United States Surgical, A Division of Tyco Healthc · Dec 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · United States Surgical, A Division of Tyco Healthc · Dec 1998
DOC VENTRAL CERVICAL STABILIZATION SYSTEM
K982443 · Depuy Motech Acromed · Jul 1998