Cleared Traditional

MCGRATH ORTHOPAEDIC BONE SCREWS (K901814) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901814 · Mcgrath Surgical , Ltd. · Orthopedic device
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Aug 1990
Decision
120d
Days
Class 2
Risk

K901814 is an FDA 510(k) clearance for the MCGRATH ORTHOPAEDIC BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mcgrath Surgical , Ltd. (Po3 5hl England, GB). The FDA issued a Cleared decision on August 21, 1990 after a review of 120 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 Mcgrath Surgical , Ltd. devices

Submission Details

510(k) Number K901814 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 23, 1990
Decision Date August 21, 1990
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K901814.
AESCULAP TITANIUM BONE SCREWS
K913415 · Aesculap, Inc. · Oct 1991
UNIVERSAL COMPRESSION SCREW
K904809 · Howmedica Corp. · Jun 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · Howmedica Corp. · Jun 1991
EXACTECH BONE SCREW
K896601 · Exactech, Inc. · Dec 1989
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989
ASNIS II GUIDED BONE SCREW
K895766 · Howmedica Corp. · Nov 1989