Cleared Traditional

K071464 - INION HEXALON BIODEGRADABLE ACL/PCL SCREW

K071464 is an FDA 510(k) clearance for INION HEXALON BIODEGRADABLE ACL/PCL SCREW, manufactured by Inion OY. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K071464 · Inion OY · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
66d
Days
Class 2
Risk

K071464 is an FDA 510(k) clearance for the INION HEXALON BIODEGRADABLE ACL/PCL SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on August 3, 2007 after a review of 66 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 Inion OY devices

FDA 510(k) Submission Details - K071464

510(k) Number K071464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date August 03, 2007
Days to Decision 66 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
56d faster than avg
Panel avg: 122d · This submission: 66d
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 681
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K071464.
DOMINATOR
K072127 · Biocomposites, Ltd. · Aug 2007
GRAFTLOCK SCREW, ST SCREW
K071952 · Biocomposites, Ltd. · Aug 2007
HEALIX ANCHOR
K071481 · Depuy Mitek, A Johnson & Johnson Company · Aug 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
K071177 · Arthrex, Inc. · Jun 2007
CANNULATED SCREW
K070617 · Fournitures Hospitalieres Industrie · Jun 2007
MODIFICATION TO BILOK SCREW
K071091 · Biocomposites, Ltd. · May 2007