Cleared Traditional

K971070 - SCARF THREAD-HEAD (TM) HEAD SCREW

K971070 is an FDA 510(k) clearance for SCARF THREAD-HEAD (TM) HEAD SCREW, manufactured by Landos, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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

FDA 510(k) Submission Details - K971070

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
Combination Product No
PCCP Authorized No
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.

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 804
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K971070.
OSTEO CANNULATED SCREW SYSTEM
K971800 · Osteonics Corp. · Jul 1997
34MM SCARF THREAD-HEAD(TM) SCREW
K971068 · Landos, Inc. · Jul 1997
TWIST-OFF (TM) SCREW
K971069 · Landos, Inc. · 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