Cleared Traditional

K071481 - HEALIX ANCHOR

K071481 is an FDA 510(k) clearance for HEALIX ANCHOR, manufactured by Depuy Mitek, A Johnson & Johnson Company. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K071481 · Depuy Mitek, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
72d
Days
Class 2
Risk

K071481 is an FDA 510(k) clearance for the HEALIX ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on August 9, 2007 after a review of 72 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.

FDA 510(k) Submission Details - K071481

510(k) Number K071481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date August 09, 2007
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K071481.
GRAFTLOCK SCREW, ST SCREW
K071952 · Biocomposites, Ltd. · Aug 2007
IFS BONE FIXATION DEVICES
K071035 · Internal Fixation Systems, Inc. · Aug 2007
PEEK KNOTLESS ANCHORS
K070389 · Biomet Sports Medicine, Inc. · Aug 2007
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K071464 · Inion OY · Aug 2007
SUBTALAR IMPLANT
K071498 · Biomet Sports Medicine, Inc. · Jul 2007
QWIX POSITIONING SCREW
K071639 · Newdeal Sas · Jul 2007
K071481 · HEALIX ANCHOR
Download PDF FDA Summary Depuy Mitek, A Johnso…