Cleared Traditional

K915424 - ARTHREX CANNULATED INTERFERENCE SCREW

K915424 is an FDA 510(k) clearance for ARTHREX CANNULATED INTERFERENCE SCREW, manufactured by Arthrex, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K915424 · Arthrex, Inc. · Orthopedic device
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Feb 1993
Decision
435d
Days
Class 2
Risk

K915424 is an FDA 510(k) clearance for the ARTHREX CANNULATED INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on February 9, 1993 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Arthrex, Inc. devices

FDA 510(k) Submission Details - K915424

510(k) Number K915424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1991
Decision Date February 09, 1993
Days to Decision 435 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
313d slower than avg
Panel avg: 122d · This submission: 435d
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 931
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K915424.
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · Techmedica, Inc. · Apr 1993
M3 LAG SCREW FIXATION SYSTEM
K924018 · Osteomed Corp. · Apr 1993
3.5MM UNIVERSAL COMPRESSION SCREW
K923477 · Howmedica Corp. · Mar 1993
ACUFEX FIXATION POST
K924514 · Acufex Microsurgical, Inc. · Oct 1992
ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW
K923256 · Alphatec Mfg., Inc. · Oct 1992
ALPHATEC SMALL FRAGMENT SET
K922166 · Alphatec Mfg., Inc. · Aug 1992