Cleared Special

K062782 - INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001

K062782 is an FDA 510(k) clearance for INION ANCHRON PLUS BIODEGRADABLE ANCHOR..., manufactured by Inion OY. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 52-day FDA review.

K062782 · Inion OY · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
52d
Days
Class 2
Risk

K062782 is an FDA 510(k) clearance for the INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on November 9, 2006 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inion OY devices

FDA 510(k) Submission Details - K062782

510(k) Number K062782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date November 09, 2006
Days to Decision 52 days
Submission Type Special
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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 217
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K062782.
BIODUCT
K053492 · Bioduct, LLC · Apr 2007
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K063497 · Scandius Biomedical, Inc. · Dec 2006
ARTHREX INTERFERENCE SCREW
K062466 · Arthrex, Inc. · Nov 2006
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K060522 · Scandius Biomedical, Inc. · Apr 2006
MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM
K052799 · Bonutti Research, Inc. · Dec 2005
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K051983 · Axya Medical, Inc. · Aug 2005