Cleared Traditional

BONE SCREW (K831873) - FDA 510(k) Clearance

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

K831873 · W.L. Gore & Associates, Inc. · Orthopedic device
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Aug 1983
Decision
60d
Days
Class 2
Risk

K831873 is an FDA 510(k) clearance for the BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K831873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1983
Decision Date August 12, 1983
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 122d · This submission: 60d
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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K831873.
VECSEI EXPANDING SCREW
K892925 · Howmedica Corp. · Aug 1989
OMNIFIT BONE SCREW
K873251 · Osteonics Corp. · Sep 1987
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979
HERBERT BONE SCREW
K792022 · Zimmer, Inc. · Oct 1979
ORTHOPEDIC DEVICES
K780235 · Biomet, Inc. · Feb 1978