(92 days)
Not Found
No
The 510(k) summary describes a mechanical bone screw and its performance testing, with no mention of AI or ML technology.
Yes
The device, a cortical bone screw, is indicated for fixation of bone fractures or for bone reconstruction, which is a therapeutic purpose.
No
Explanation: The device described is a bone screw intended for fixation of bone fractures or reconstruction, which is a therapeutic function, not a diagnostic one. It is used to treat existing conditions rather than to identify or diagnose them.
No
The device description clearly states it is a physical screw manufactured from ASTM F136 (Ti-6AI-4V ELI) and describes its physical features and mechanical testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone fractures or for bone reconstruction." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "cortical bone screw" with features like self-drilling, self-tapping, and a snap-off mechanism. These are all characteristics of a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a disease or condition.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair bone.
N/A
Intended Use / Indications for Use
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of Small Bone Fragments
- . Weil osteotomy
- Mono-cortical fixation .
- Osteotomies and fractures fixation in the foot and hand
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The CHARLOTTE™ Snap-Off screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
The design features and function of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the design features previously cleared under the CHARLOTTE™ Snap-Off screw and are highlighted below:
- Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
- . Self-drilling and self-tapping features on distal threads
- Groove in head of screw around neck connection to drive mechanism to allow for snap off of ● drive mechanism shaft below screw head surface
The subject screws in this Special 510(k) include a change in the tip geometry of the snap-off 2,0mm diameter screw as well as the introduction of additional screw lengths to the 2.0mm and 2.7mm diameter screws to fill in sizes not previously included. Additionally, screws that are provided sterile have been added.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (specifically foot and hand)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing per ASTM F543-02 includes ultimate torque, insertion torque, fully-seated torque, neck break-off torque, removal torque, and axial pull-out. These test demonstrated that the performance of the subject screw is statistically equivalent or greater than the predicate screw.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K043583 - CHARLOTTE™ Snap-Off Screw, K050819 - CHARLOTTE™ Snap-Off Screw
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that appears to be a series of overlapping, angled lines, possibly representing wings or a similar design element. The overall impression is a logo or branding element, likely for a company or product named Wright.
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 www.wmt.com
510(K) SUMMARY
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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CHARLOTTE™ Snap-Off Screw.
- Submitted By:
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002
Date:
Contact Person:
March 5, 2014
Leslie Fitch
Senior Regulatory Affairs Specialist (901) 867-4120
- Proprietary Name:
CHARLOTTE™ Snap-Off Screw
Common Name:
Smooth or threaded metallic bone fixation fastener
Classification Name and Reference:
21 CFR 888.3040 - Class II
Device Product Code, Device Panel:
HWC: Orthopedic
- Predicate Devices:
K043583 - CHARLOTTE™ Snap-Off Screw K050819 - CHARLOTTE™ Snap-Off Screw
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4. Device Description
The CHARLOTTE™ Snap-Off screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
The design features and function of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the design features previously cleared under the CHARLOTTE™ Snap-Off screw and are highlighted below:
- Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
- . Self-drilling and self-tapping features on distal threads
- Groove in head of screw around neck connection to drive mechanism to allow for snap off of ● drive mechanism shaft below screw head surface
The subject screws in this Special 510(k) include a change in the tip geometry of the snap-off 2,0mm diameter screw as well as the introduction of additional screw lengths to the 2.0mm and 2.7mm diameter screws to fill in sizes not previously included. Additionally, screws that are provided sterile have been added.
Intended Use ડ.
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Fixation of Small Bone Fragments ●
- . Weil osteotomy
- Mono-cortical fixation .
- Osteotomies and fractures fixation in the foot and hand .
-
- Technological Characteristics Comparison
The CHARLOTTE™ Snap-Off Screw and the legally marketed predicate CHARLOTTE™ Snap-Off Screw have identical indications, utilize the same instrumentation, and are identical in material. Sterilization methods have been updated to reflect the addition of products that are provided sterile.
7. Substantial Equivalence - Non-Clinical Evidence
Mechanical testing per ASTM F543-02 includes ultimate torque, insertion torque, fully-seated torque, neck break-off torque, removal torque, and axial pull-out. These test demonstrated that the performance of the subject screw is statistically equivalent or greater than the predicate screw.
8. Substantial Equivalence - Clinical Evidence
N/A
9. Substantial Equivalence - Conclusions
The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Coutrol Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Wright Medical Technologies, Inc. Ms. Leslie Fitch Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K133713
Trade/Device Name: CHARLOTTE™ Snap-Off Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 29, 2014 Received: February 10, 2014
Dear Ms. Fitch:
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 commerce 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Leslie Fitch
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Vincen Døevlin -S
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CHARLOT TE SHERE FRE STRENE CHAWS
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
DIRECEST TO (A) Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name CHARLOTTE™ Snap-Off Screw
Indications for Use (Describe)
The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone reconstruction. Examples include:
- · Fixation of Small Bone Fragments
- · Weil osteotomy
- · Mono-cortical fixation
- · Osteotomics and fractures fixation in the foot and hand
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ... " : Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Elizabeth @ Frank -S
Division of Orthopedic Devices
FORM FDAig9881e(@ddBJechnology, Inc
CONERCENTRAL