(51 days)
Not Found
No
The summary describes a system of physical implants (screws and bolts) for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for fracture fixation, osteotomies, reconstruction, non-unions, and fusions of bones, which are therapeutic medical procedures aimed at treating conditions or injuries.
No
Explanation: The device is a surgical implant (screws and bolts) used for fracture fixation and reconstruction, not for identifying or diagnosing a medical condition.
No
The device description explicitly states that the system consists of titanium alloy screws and bolts, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SALVATION™ Beams and Bolts System is described as a system of titanium alloy screws and bolts used for surgical fixation of bones in the foot and ankle.
- Intended Use: The intended use is for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones. These are all surgical procedures performed directly on the patient's body, not tests performed on samples outside the body.
The information provided clearly indicates this is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The SALVATION™ Beams and Bolts System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
Product codes
HWC
Device Description
The SALVATION™ Fusion Beams and Bolts System consists of titanium alloy screws and bolts used for midfoot reconstruction. The system features both solid core and cannulated options in various diameters and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus
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)
Performance testing and analysis that demonstrated substantial equivalence includes insertion, removal, pull-out and ultimate torque, as well as cross-sectional analysis and four point bending.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053136, K081071, K070525, K021932, K111994
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.
0
Headquarters Wright Medical Technology
Memphis, IN 38117
901 867 9971 wint.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 SALVATION™ Beams and Bolts System.
(a)(1). Submitted By:
Date:
Contact Person:
(a)(2). Proprietary Name:
Common Name:
Classification Name and Reference: Device Product Code, Device Panel:
(a)(3). Predicate Devices:
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
March 21, 2014
Leslie Fitch, PhD Senior Regulatory Affairs Specialist Office: (901) 867-4120 Fax: (901) 867-4190
SALVATION™ Beams and Bolts System
Bone Screw
21 CFR 888.3040 - Class II
HWC, Orthopedic
K053136: Charlotte Carolina Jones Screw K081071: Synthes 6.5mm Midfoot Fusion Bolt K070525: Charlotte Multi use compression Screw K021932: Synthes Cannulated 6.5 mm Screw K111994: Smith and Nephew Cannulated Screw
(a)(4). Device Description
The SALVATION™ Fusion Beams and Bolts System consists of titanium alloy screws and bolts used for midfoot reconstruction. The system features both solid core and cannulated options in various diameters and lengths.
Image /page/0/Picture/23 description: The image is a low-resolution, dark, and blurry image. It is difficult to discern any specific details or objects within the image. The overall impression is one of poor quality and lack of clarity. There are some lighter areas that could be text, but it is too blurry to read.
WRIGHT.
FOCUSED EXCELLENCE
Image /page/0/Picture/25 description: The image shows a date, "MAY 1 5 2014", in bold, black font. The month is spelled out in capital letters, followed by the numerical day and year. The date appears to be extracted from a document or letter, given the font and layout.
WRIGHT.
FOCUSED EXCELLENCE
1
Image /page/1/Picture/11 description: The image shows a geometric shape that appears to be a trapezoid or a truncated triangle. The shape is divided into three distinct sections with varying shades. The top section is the lightest, the middle section is a medium shade, and the bottom section is the darkest.
(a)(5). INTENDED USE
The SALVATION™ Beams and Bolts System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
(a)(6). Technological Characteristics Comparison
The SALVATION™ Fusion Beams and Bolts System is technologically substantially equivalent to predicate devices in material, diameter, and length.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and analysis that demonstrated substantial equivalence includes insertion, removal, pull-out and ultimate torque, as well as cross-sectional analysis and four point bending.
(b)(2). Substantial Equivalence - Clinical Evidence N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system 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 device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
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 Leslie Fitch, Ph.D. Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K140741
Trade/Device Name: SALVATION™ Beams and Bolts System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 20, 2014 Received: March 25, 2014
Dear Dr. 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 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.
3
Page 2 - Leslie Fitch. Ph.D.
If 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" (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/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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K140741
Device Name
SALVATION Beams and Bolts System
Indications for Use (Describe)
Beams and Bolts System is indicated for fracture fixation, osteolomies, reconstruction The SALVATIONTM procedures, non-unions, and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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) (Signature)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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