Cleared Special

DARCO HEADLESS COMPRESSION SCREW (K080850) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080850 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
15d
Days
Class 2
Risk

K080850 is an FDA 510(k) clearance for the DARCO HEADLESS COMPRESSION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on April 10, 2008 after a review of 15 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K080850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2008
Decision Date April 10, 2008
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
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 403
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K080850.
SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
K081700 · Synthes (Usa) · Jul 2008
SYNTHES 6.5MM MIDFOOT FUSION BOLT
K081071 · Synthes (Usa) · May 2008
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS
K080943 · Synthes (Usa) · Apr 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · Smith & Nephew, Inc. · Mar 2008
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
K071437 · KARL STORZ Endoscopy-America, Inc. · Sep 2007
ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW
K071177 · Arthrex, Inc. · Jun 2007