Cleared Special

K071863 - ACTIVAPIN

K071863 is an FDA 510(k) clearance for ACTIVAPIN, manufactured by Bioretec, Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 56-day FDA review.

K071863 · Bioretec, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
56d
Days
Class 2
Risk

K071863 is an FDA 510(k) clearance for the ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS). Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Cleared decision on August 31, 2007 after a review of 56 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. 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 Bioretec, Ltd. devices

FDA 510(k) Submission Details - K071863

510(k) Number K071863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2007
Decision Date August 31, 2007
Days to Decision 56 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 111
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K071863.
APTUS K-WIRE SYSTEM
K092038 · Medartis AG · Sep 2009
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K083490 · Biopro, Inc. · Mar 2009
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · OrthoPediatrics Corp. · Oct 2008
KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES
K070561 · Teleflex Medical · May 2007
ARTHREX CROSSPIN, MODEL AR-1964P
K063719 · Arthrex, Inc. · Mar 2007
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · Arthrex, Inc. · Nov 2005