Cleared Traditional

K973005 - THE CORIFIX LIGAMENT ANCHOR

K973005 is an FDA 510(k) clearance for THE CORIFIX LIGAMENT ANCHOR, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K973005 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
89d
Days
Class 2
Risk

K973005 is an FDA 510(k) clearance for the THE CORIFIX LIGAMENT ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on November 10, 1997 after a review of 89 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 Corin USA devices

FDA 510(k) Submission Details - K973005

510(k) Number K973005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date November 10, 1997
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 683
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K973005.
MENISCAL REPAIR DEVICE
K974538 · Linvatec Corp. · Mar 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758 · Linvatec Corp. · Feb 1998
ORTHOPEDIC SCREW SYSTEM
K972217 · Ferguson Medical · Nov 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586 · Spinal Concepts, Inc. · Nov 1997
DEPUY DUPONT ABSORBABLE SET SCREW
K972494 · Depuy, Inc. · Oct 1997
BTI CORTICAL BONE SCREWS
K972403 · Biodynamic Technologies, Inc. · Aug 1997