Cleared Traditional

K021030 - TITANIUM CANNULATED INTERFERENCE SCREW

K021030 is an FDA 510(k) clearance for TITANIUM CANNULATED INTERFERENCE SCREW, manufactured by Future Medical Systems, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021030 · Future Medical Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
88d
Days
Class 2
Risk

K021030 is an FDA 510(k) clearance for the TITANIUM CANNULATED INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Future Medical Systems, Inc. (Glen Burnie, US). The FDA issued a Cleared decision on June 25, 2002 after a review of 88 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 Future Medical Systems, Inc. devices

FDA 510(k) Submission Details - K021030

510(k) Number K021030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date June 25, 2002
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 885
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K021030.
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · Inion , Ltd. · Jul 2002
SMALL HAMMER TOE PIN
K021828 · Biomet, Inc. · Jul 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · Biomet, Inc. · Jun 2002
BIOSCREW XTRALOK
K013131 · Linvatec Corp. · Jun 2002
PRE-LOADED BIOSTINGER HORNET
K020377 · Linvatec Corp. · May 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · Arthrex, Inc. · Apr 2002