Cleared Special

K033804 - BIOANCHOR WITH DISPOSABLE DRIVER

K033804 is the FDA 510(k) clearance for BIOANCHOR WITH DISPOSABLE DRIVER by Linvatec Corp.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 23-day FDA review.

K033804 · Linvatec Corp. · Orthopedic device
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Dec 2003
Decision
23d
Days
Class 2
Risk

K033804 is an FDA 510(k) clearance for the BIOANCHOR WITH DISPOSABLE DRIVER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on December 31, 2003 after a review of 23 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 Linvatec Corp. devices

Submission Details

510(k) Number K033804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2003
Decision Date December 31, 2003
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 556
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K033804.
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · United States Surgical, A Division of Tyco Healthc · Mar 2004
SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS
K033975 · Synthes (Usa) · Mar 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · Acumed, LLC · Jan 2004
LORENZ STERNAL CLOSURE SYSTEM
K033740 · Walter Lorenz Surgical, Inc. · Dec 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · Stryker Endoscopy · Nov 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · Biomet, Inc. · Nov 2003