(31 days)
Not Found
No
The summary describes a mechanical bone screw system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a screw designed for fixation of bone fractures, which is a structural implant rather than a therapeutic device that delivers treatment.
No
The device is a system of screws indicated for fixation of bone fractures or bone reconstruction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a screw manufactured from 316L Cold-Worked Stainless Steel, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The CHARLOTTE™ CAROLINA™ Jones Fracture System is a surgical implant (a bone screw) used to fix bone fractures. It is physically placed within the body to provide structural support.
- Intended Use: The intended use is for the fixation and reconstruction of bone fractures, which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a device used in orthopedic surgery, not a diagnostic test.
N/A
Intended Use / Indications for Use
The CHARLOTTE™ CAROLINA™ Jones Fracture System is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- Fixation of malunions and nonunions
- Acute fractures
- Avulsion fractures
- Repetitive stress fractures
- Jones Fractures
- Malleolar Fractures
- Talus Fractures
- Greater Tuberosity Fractures
Product codes
HWC
Device Description
The CHARLOTTE™ CAROLINA™ Jones Fracture System screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
The design features of the CHARLOTTE™ CAROLINA™ Jones Fracture System screw are substantially equivalent to the design features previously cleared under the 5th Metatarsal Fracture Screw and are highlighted below:
- Manufactured from 316L Cold-Worked Stainless Steel (ASTM F138)
- Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm
- Offered in lengths ranging from 40mm-70mm in 5mm increments
- Threads run 35% of screw length
The subject screws in this Special 510(k) include a change in the screw head size as well as a change in the driver interface to increase ease of use. 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
5th Metatarsal, Malleolar, Talus, Greater Tuberosity
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
Mechanical testing related to the torsional properties and axial-pull out strength supports the equivalence of the subject device and shows that no new worst-case devices are introduced in this system. The safety and effectiveness of the CHARLOTTE™ CAROLINA™ Jones Fracture System Screw is adequately supported by testing, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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MAY 1 5 2014
K140952 Pq.1/2
Headquarters WWF 33311; 2419m 1: 13 13 1000 1 1
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ਕੀ।। ਉਨੇਤੇ ਸ਼ੁੱਤ । wm1.com
Image /page/0/Picture/5 description: The image contains a logo with the word "WRIGHT" in bold, black letters. Below the word "WRIGHT", there is a smaller tagline that reads "FOCUSED EXCELLENCE". To the left of the word "WRIGHT", there is a graphic element that appears to be a stylized symbol or icon, also in black.
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 CHARLOTTE™ CAROLINA™ Jones Fracture System Screw.
Wright Medical Technology, Inc. 1. Submitted By: 1023 Cherry Road Memphis, TN 38117 Date: March 24, 2014 Contact Person: Leslie Fitch Senior Regulatory Affairs Specialist (901) 867-4120 Office (901) 867-4190 Fax CHARLOTTE™ CAROLINA™ Jones Fracture 2. Proprietary Name: System Screw Common Name: Smooth or threaded metallic bone fixation fastener Classification Name and Reference: 21 CFR 888.3040- Class II HWC - Orthopedic Device Product Code, Device Panel:
3. Predicate Device:
K053136 5th Metatarsal Fracture Screw
4. Device Description
The CHARLOTTE™ CAROLINA™ Jones Fracture System screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
The design features of the CHARLOTTE™ CAROLINA™ Jones Fracture System screw are substantially equivalent to the design features previously cleared under the 5th Metatarsal Fracture Screw and are highlighted below:
- o Manufactured from 316L Cold-Worked Stainless Steel (ASTM F138)
- o Offered in three diameters: 4.5mm, 5.5mm, and 6.5mm
- o Offered in lengths ranging from 40mm-70mm in 5mm increments
- o Threads run 35% of screw length
1
The subject screws in this Special 510(k) include a change in the screw head size as well as a change in the driver interface to increase ease of use. Additionally, screws that are provided sterile have been added.
5. Intended Use
The CHARLOTTE™ CAROLINA™ Jones Fracture System is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- Fixation of malunions and nonunions ◆
- . Acute fractures
- . Avulsion fractures
- � Repetitive stress fractures
- Jones Fractures .
- Malleolar Fractures .
- Talus Fractures .
- Greater Tuberosity Fractures .
6. Technological Characteristics Comparison
The CHARLOTTE™ CAROLINA™ Jones Fracture System Screw and the legally marketed predicate 5th Metatarsal Fracture Screw have identical indications, utilize the same instrumentation, and are identical in material. The modification to the system includes a change in the size and driver interface in the head of the screw and the addition of parts provided sterile.
7. Substantial Equivalence- Non-Clinical Evidence
Mechanical testing related to the torsional properties and axial-pull out strength supports the equivalence of the subject device and shows that no new worst-case devices are introduced in this system. The safety and effectiveness of the CHARLOTTE™ CAROLINA™ Jones Fracture System Screw is adequately supported by testing, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.
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.
Image /page/1/Picture/20 description: The image is a black and white photograph of a triangular shape. The triangle is oriented vertically, with the base at the bottom and the apex at the top. The lower portion of the triangle is black, while the upper portion is white. The image is simple and abstract, with no other objects or details present.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2014
Wright Medical Technology, Incorporated Ms. Leslie Fitch Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K140952
Trade/Device Name: CHARLOTTE™ CAROLINA™ Jones Fracture System Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 24, 2014 Received: April 14, 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 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
3
Page 2 - Ms. Leslie Fitch
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.
1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K140952
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
CHARLOTTE™ CAROLINA™ Jones Fracture System Screw
indications for Use (Describe)
The CHARLOTTE™ CAROLINA™ Jones Fracture System is indicated for fixation of bone fractures or for bone reconstruction of the 5th Metatarsal. Examples include:
- · Fixation of malunions and nonunions
- · Acute fractures
- · Avulsion fractures
- · Repetitive stress fractures
- · Jones Fractures
- · Malleolar Fractures
- Talus Fractures
- Greater Tuberosity Fractures
Type of Use (Select one or both, as applicable)
[x] 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.
人都能 . FOR FDA USE ONLY : . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth L. Frank -S
Division of Orthopedic Devices
FORM FDA 3881 (1/14) CONFIDENTIAL
PSC Publishing Services ( 301) 441-6740 E1 - 1
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.