Cleared Traditional

K963739 - LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS

K963739 is an FDA 510(k) clearance for LEIBINGER - LUHR SMALL ORTHOPEDIC BONE ..., 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 127-day FDA review.

K963739 · Howmedica Leibinger, Inc. · Orthopedic device
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Jan 1997
Decision
127d
Days
Class 2
Risk

K963739 is an FDA 510(k) clearance for the LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS. 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 January 22, 1997 after a review of 127 days - within the typical 510(k) review window.

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 - K963739

510(k) Number K963739 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 17, 1996
Decision Date January 22, 1997
Days to Decision 127 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 122d · This submission: 127d
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 794
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K963739.
TITANIUM ALLOY BONE SCREWS
K970549 · Aesculap, Inc. · Apr 1997
BIOMET BONE SCREW
K964970 · Biomet, Inc. · Apr 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · Smith & Nephew, Inc. · Feb 1997
HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
K955733 · Depuy, Inc. · Nov 1996
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K960652 · Linvatec Corp. · Nov 1996
DEPUY MOTECH PEAK FIXATION SYSTEM
K963350 · Depuy, Inc. · Nov 1996