Cleared Traditional

K041274 - RESORBABLE INTERFERENCE SCREW

K041274 is an FDA 510(k) clearance for RESORBABLE INTERFERENCE SCREW, manufactured by Arthrotek, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K041274 · Arthrotek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
77d
Days
Class 2
Risk

K041274 is an FDA 510(k) clearance for the RESORBABLE INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 28, 2004 after a review of 77 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 Arthrotek, Inc. devices

FDA 510(k) Submission Details - K041274

510(k) Number K041274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date July 28, 2004
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 943
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K041274.
INION TRINION BIODEGRADABLE MENISCUS SCREW
K031714 · Inion , Ltd. · Aug 2004
VILEX BONE PLATE SYSTEM
K041287 · Vilex, Inc. · Aug 2004
TALUS OF VILEX (TOV)
K041289 · Vilex, Inc. · Aug 2004
LACTOSCREW SCREW ANCHOR
K033355 · Biomet Orthopedics, Inc. · Jun 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939 · Fournitures Hospitalieres Industrie · Jun 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · Synthes (Usa) · Jun 2004