Cleared Traditional

K963937 - NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW

K963937 is an FDA 510(k) clearance for NORTHWEST PRECISION TECHNOLOGIES 6.5 MM..., manufactured by Northwest Precision Technologies. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K963937 · Northwest Precision Technologies · Orthopedic device
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Jan 1997
Decision
113d
Days
Class 2
Risk

K963937 is an FDA 510(k) clearance for the NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Northwest Precision Technologies (The Dalles, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 113 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 Northwest Precision Technologies devices

FDA 510(k) Submission Details - K963937

510(k) Number K963937 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 01, 1996
Decision Date January 22, 1997
Days to Decision 113 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 122d · This submission: 113d
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 921
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K963937.
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
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · Howmedica Leibinger, Inc. · Jan 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