Cleared Traditional

K012676 - REPROCESSED USED

K012676 is an FDA 510(k) clearance for REPROCESSED USED, manufactured by Adven Medical. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K012676 · Adven Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
174d
Days
Class 1
Risk

K012676 is an FDA 510(k) clearance for the REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on February 4, 2002 after a review of 174 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Adven Medical devices

FDA 510(k) Submission Details - K012676

510(k) Number K012676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date February 04, 2002
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 34
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K012676.
SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE
K063688 · The Anspach Effort, Inc. · Jan 2007
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
K043310 · Synthes (Usa) · Jan 2005
AESCULAP HILAN MOTOR SYSTEM
K973736 · Aesculap, Inc. · Dec 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · Synthes (Usa) · May 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
K970088 · Richard Wolf Medical Instruments Corp. · Apr 1997
SYNTHES STERILE DRILL BITS
K962913 · Synthes (Usa) · Nov 1996