Cleared Traditional

CHARLOTTE HIGH-DEMAND COMPRESSION SCREW (K043281) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043281 · Wrightmedicaltechnologyinc · Orthopedic device
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Jan 2005
Decision
54d
Days
Class 2
Risk

K043281 is an FDA 510(k) clearance for the CHARLOTTE HIGH-DEMAND 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 January 19, 2005 after a review of 54 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K043281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date January 19, 2005
Days to Decision 54 days
Submission Type Traditional
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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K043281.
SYNTHES 3.5MM CORTEX SCREWS
K043185 · Synthes (Usa) · Feb 2005
CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003
K043583 · Wrightmedicaltechnologyinc · Jan 2005
MULTI-USE COMPRESSION SCREW
K043102 · Wrightmedicaltechnologyinc · Jan 2005
BIO-CORE INTERFERENCE SCREW
K042552 · Biomet, Inc. · Dec 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337 · Arthrex, Inc. · Dec 2004
ARTHREX TRIMIT FAMILY
K041189 · Arthrex, Inc. · Nov 2004