(54 days)
The CHARLOTTE™ High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of bone fragments, in long bones or small bones fractures
- Fracture management in the foot or hand
- Arthrodesis in hand, foot or ankle surgery
- Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- Treatment of inferior tibio fibular diastasis
- Hindfoot arthrodesis
The design features of the CHARLOTTE™ High-Demand Compression Screw are summarized below:
Screws
- Available in 1 diameter, 15 lengths, and 3 thread lengths.
- Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
- The distal tip of the screw is to be self drilling.
- The distal threaded portion is to be self tapping.
- Packaged non-sterile and sold as a set in a suitable sterilization tray or individually.
Compression Caps - Available in one size.
- Available with either a grooved or smooth outer surface.
- Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
The provided text is a 510(k) summary for the CHARLOTTE™ High-Demand Compression Screw. It discusses the device's intended use, description, and substantial equivalence to a previously cleared predicate device.
However, this document does not contain information about acceptance criteria or performance studies in the context of AI/ML or diagnostic devices. It describes a physical medical device (a bone fixation screw) and its clearance process based on substantial equivalence to an existing product, rather than performance metrics from a clinical study or an algorithm's performance.
Therefore, I cannot provide a response filling in the requested table and information points as they are not applicable to the content of this document. This document does not describe:
- Acceptance criteria for an AI/ML device.
- "Reported device performance" in terms of sensitivity, specificity, or similar metrics.
- Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, or how ground truth was established for training sets.
The "study" mentioned is "testing conforming to ASTM 543-02" which refers to a standard for material and mechanical properties of the screw, not a clinical or AI performance study. The substantial equivalence is based on design features, material, and indications for use being similar to the predicate device, confirmed by adherence to this ASTM standard.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the CHARLOTTE™ High-Demand Compression Screw.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | November 24, 2004 |
| Contact Person: | Wesley L. Reed Regulatory Affairs Specialist |
| Proprietary Name: | CHARLOTTE™ High-Demand CompressionScrew |
| Common Name: | Bone Fixation Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener - Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3040 Smooth or threaded metallic bonefixation fastener - Class II |
DEVICE INFORMATION
A. INTENDED USE
The CHARLOTTE™ High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis
B. DEVICE DESCRIPTION
The design features of the CHARLOTTE™ High-Demand Compression Screw are summarized below:
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Screws
- · Available in 1 diameter, 15 lengths, and 3 thread lengths.
- Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
- · The distal tip of the screw is to be self drilling.
- · The distal threaded portion is to be self tapping.
- · Packaged non-sterile and sold as a set in a suitable sterilization tray or individually.
Compression Caps
- · Available in one size.
- · Available with either a grooved or smooth outer surface.
- · Manufactured from Stainless Steel conforming to ASTM F 138, Cold Worked.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the CHARLOTTE™ High-Demand Compression Screw are substantially equivalent to the previously cleared Newdeal I.CO.S.® Screw. This was confirmed by testing conforming to ASTM 543-02. The safety and effectiveness of the CHARLOTTE™ High-Demand Compression Screw is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 2005
Mr. Wesley L. Reed Regulatory Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K043281
Trade/Device Name: CHARLOTTE™ High Demand Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: November 24, 2004 Received: November 26, 2004
Dear Mr. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commence prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Wesley L. Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general s. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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043281
Indications for Use
510(k) Number (if known):
Device Name: CHARLOTTE™ High Demand Compression Screw
Indications For Use:
The High-Demand Compression Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Fixation of bone fragments, in long bones or small bones fractures
- · Fracture management in the foot or hand
- · Arthrodesis in hand, foot or ankle surgery
- · Mono or Bi-cortical osteotomies in the foot or hand or in long bones
- · Treatment of inferior tibio fibular diastasis
- · Hindfoot arthrodesis
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1
Mark N. Melhusso
al. Restorative, and Neurological Devices
510(k) Number K043281
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.