Cleared Traditional

K080773 - THOR ANTERIOR PLATING SYSTEM

K080773 is an FDA 510(k) clearance for THOR ANTERIOR PLATING SYSTEM, manufactured by Stryker Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K080773 · Stryker Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
82d
Days
Class 2
Risk

K080773 is an FDA 510(k) clearance for the THOR ANTERIOR PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 82 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 Stryker Spine devices

FDA 510(k) Submission Details - K080773

510(k) Number K080773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2008
Decision Date June 09, 2008
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
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 621
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K080773.
ACTIVE ANTERIOR CERVICAL PLATE SYSTEM
K073500 · Sanacor · Jul 2008
VIP ANTERIOR CERVICAL PLATE SYSTEM
K081391 · Globus Medical, Inc. · Jul 2008
VERTEBRON SSP CERVICAL PLATING SYSTEM
K081567 · Vertebron, Inc. · Jul 2008
FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
K073708 · Precision Surgery , Ltd. · Jun 2008
ARCOFIX
K080020 · Synthes Spine Co.Lp · May 2008
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K080646 · Biomet Spine · May 2008