Cleared Traditional

K972403 - BTI CORTICAL BONE SCREWS

K972403 is an FDA 510(k) clearance for BTI CORTICAL BONE SCREWS, manufactured by Biodynamic Technologies, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K972403 · Biodynamic Technologies, Inc. · Orthopedic device
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Aug 1997
Decision
64d
Days
Class 2
Risk

K972403 is an FDA 510(k) clearance for the BTI CORTICAL BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Biodynamic Technologies, Inc. (Deerfield Beach, US). The FDA issued a Cleared decision on August 29, 1997 after a review of 64 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. 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 Biodynamic Technologies, Inc. devices

FDA 510(k) Submission Details - K972403

510(k) Number K972403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date August 29, 1997
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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 K972403.
THE CORIFIX LIGAMENT ANCHOR
K973005 · Corin USA · Nov 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586 · Spinal Concepts, Inc. · Nov 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · Depuy, Inc. · Oct 1997
STRYKER WEDGE INTERFERENCE SCREW SYSTEM
K972233 · Stryker Endoscopy · Aug 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · Osteonics Corp. · Jul 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · Osteonics Corp. · Jul 1997