K940207 is an FDA 510(k) clearance for TITANIUM ALLOY BONE SCREWS, manufactured by Aesculap, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 179-day FDA review.
K940207 is an FDA 510(k) clearance for the TITANIUM ALLOY BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 179 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.
| Product Code | HWC Screw, Fixation, Bone |
| Device Class | Class 2 - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
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.
Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.