Cleared Special

K992947 - CANNULATED SMARTSCREW MODELS 224540C, 224570C

K992947 is an FDA 510(k) clearance for CANNULATED SMARTSCREW MODELS 224540C, manufactured by Bionx Implants, Ltd.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 20-day FDA review.

K992947 · Bionx Implants, Ltd. · Orthopedic device
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Sep 1999
Decision
20d
Days
Class 2
Risk

K992947 is an FDA 510(k) clearance for the CANNULATED SMARTSCREW MODELS 224540C, 224570C. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bionx Implants, Ltd. (Tampere, FI). The FDA issued a Cleared decision on September 21, 1999 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Bionx Implants, Ltd. devices

FDA 510(k) Submission Details - K992947

510(k) Number K992947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1999
Decision Date September 21, 1999
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 810
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