Cleared Special

K050813 - ABC 2 SCREW

K050813 is an FDA 510(k) clearance for ABC 2 SCREW, manufactured by Aesculap, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 34-day FDA review.

K050813 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
34d
Days
Class 2
Risk

K050813 is an FDA 510(k) clearance for the ABC 2 SCREW. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on May 4, 2005 after a review of 34 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K050813

510(k) Number K050813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2005
Decision Date May 04, 2005
Days to Decision 34 days
Submission Type Special
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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

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 620
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K050813.
TRANS1 AXIALIF SYSTEM
K050965 · Trans1 Incorporated · Jun 2005
BASIS SPINAL SYSTEM
K051039 · Medtronic Sofamor Danek USA, Inc. · May 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · Blackstone Medical, Inc. · May 2005
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
K050588 · Innovative Spinal Design, LLC · Apr 2005
LANX ANTERIOR CERVICAL PLATE SYSTEM
K050774 · Lanx, LLC · Apr 2005
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · Aesculap, Inc. · Apr 2005