Cleared Traditional

SCARF THREAD-HEAD (TM) HEAD SCREW (K971070) - FDA 510(k) Clearance

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

K971070 · Landos, Inc. · Orthopedic device
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Jul 1997
Decision
107d
Days
Class 2
Risk

K971070 is an FDA 510(k) clearance for the SCARF THREAD-HEAD (TM) HEAD SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Landos, Inc. (Malvern, US). The FDA issued a Cleared decision on July 9, 1997 after a review of 107 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 Landos, Inc. devices

Submission Details

510(k) Number K971070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date July 09, 1997
Days to Decision 107 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 122d · This submission: 107d
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 K971070.
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · Depuy, Inc. · Apr 1998
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · Depuy, Inc. · Oct 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · Osteonics Corp. · Jul 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · Osteonics Corp. · Jul 1997
OSTEO SMALL AND MINI BONE SCREWS
K971778 · Osteonics Corp. · Jun 1997
DEPUY LOW PROFILE BONE SCREW
K970929 · Depuy, Inc. · Jun 1997