Cleared Special

K070525 - CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER

K070525 is an FDA 510(k) clearance for CHARLOTTE 7.0 MULTI-USE COMPRESSION SCR..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 34-day FDA review.

K070525 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
34d
Days
Class 2
Risk

K070525 is an FDA 510(k) clearance for the CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 29, 2007 after a review of 34 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

FDA 510(k) Submission Details - K070525

510(k) Number K070525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date March 29, 2007
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

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 972
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K070525.
LAGWIRE SYSTEM
K070393 · Fxdevices · May 2007
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
K070906 · Zimmer, Inc. · May 2007
MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
K070507 · Science For Biomaterials · Mar 2007
MEMOMETAL FIXOS SCREWS
K070039 · Memometal Technologies · Mar 2007
UNITY ALPHA SYSTEM
K062820 · Bonutti Research, Inc. · Mar 2007
OSTEOMED HEADLESS CANNULATED SCREW SYSTEM
K063298 · Osteomed LP · Mar 2007