Cleared Traditional

K981187 - ACL AVULSION LAG SCREW WITH SHEATH MODE...

K981187 is the FDA 510(k) clearance for ACL AVULSION LAG SCREW WITH SHEATH MODE... by Arthrex, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981187 · Arthrex, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
90d
Days
Class 2
Risk

K981187 is an FDA 510(k) clearance for the ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001. 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 July 1, 1998 after a review of 90 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 Arthrex, Inc. devices

Submission Details

510(k) Number K981187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date July 01, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K981187.
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662 · DePuy Orthopaedics, Inc. · Oct 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · Biomet, Inc. · Oct 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222 · Synthes (Usa) · Jul 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320 · Buckman Co., Inc. · Jun 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K981670 · Depuy, Inc. · Jun 1998
RCI FIXATION SCREWS
K980841 · Smith & Nephew, Inc. · May 1998