Cleared Traditional

K082282 - HEALIX TI ANCHOR

K082282 is an FDA 510(k) clearance for HEALIX TI ANCHOR, manufactured by Depuy Mitek, A Johnson & Johnson Co.. 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.

K082282 · Depuy Mitek, A Johnson & Johnson Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
88d
Days
Class 2
Risk

K082282 is an FDA 510(k) clearance for the HEALIX TI ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Co. (Raynham, US). The FDA issued a Cleared decision on November 7, 2008 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 Depuy Mitek, A Johnson & Johnson Co. devices

FDA 510(k) Submission Details - K082282

510(k) Number K082282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date November 07, 2008
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 783
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K082282.
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