Cleared Traditional

K970912 - LEIBINGER SELF-DRILLING SCREW

K970912 is an FDA 510(k) clearance for LEIBINGER SELF-DRILLING SCREW, manufactured by Howmedica Leibinger, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K970912 · Howmedica Leibinger, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 1997
Decision
203d
Days
Class 2
Risk

K970912 is an FDA 510(k) clearance for the LEIBINGER SELF-DRILLING SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Howmedica Leibinger, Inc. (Dallas, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 203 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 Howmedica Leibinger, Inc. devices

FDA 510(k) Submission Details - K970912

510(k) Number K970912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1997
Decision Date October 01, 1997
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
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 793
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K970912.
ORTHOPEDIC SCREW SYSTEM
K972217 · Ferguson Medical · Nov 1997
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
ACUFEX SCREW CANNULA
K972599 · Smith & Nephew Endoscopy, Inc. · Sep 1997
BTI CORTICAL BONE SCREWS
K972403 · Biodynamic Technologies, Inc. · Aug 1997