Cleared Traditional

K021233 - AAP CANNULATED SCREWS

K021233 is an FDA 510(k) clearance for AAP CANNULATED SCREWS, manufactured by Aap Implantate AG. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K021233 · Aap Implantate AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
235d
Days
Class 2
Risk

K021233 is an FDA 510(k) clearance for the AAP CANNULATED SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on December 9, 2002 after a review of 235 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Aap Implantate AG devices

FDA 510(k) Submission Details - K021233

510(k) Number K021233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2002
Decision Date December 09, 2002
Days to Decision 235 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
113d slower than avg
Panel avg: 122d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K021233.
STRYKER XCEL ANCHOR SYSTEM
K023013 · Stryker Endoscopy · Feb 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · Biomet Orthopedics, Inc. · Jan 2003
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · Howmedica Osteonics Corp. · Dec 2002
MODULAR HEAD BONE SCREW
K022952 · Biomet, Inc. · Dec 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · Osteomed Corp. · Oct 2002
BIOSTEON CROSS PIN
K021351 · Biocomposites, Ltd. · Oct 2002