(189 days)
No
The summary describes a mechanical implant system for foot and ankle reconstruction 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, reconstruction procedures, and fusions, which are therapeutic interventions.
No
The device is indicated for surgical procedures like fracture fixation, osteotomies, reconstruction, and fusions, rather than for diagnosing conditions. It is a tool for treatment, not diagnosis.
No
The device description explicitly mentions hardware components like "SALVATION Midfoot Nail," "proximal threads," and "distal cross screw," and the performance studies include hardware testing like "Static Bend Testing" and "Construct Fatigue Testing."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing bones in the foot and ankle. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a nail, beams, and bolts designed for surgical reconstruction. This is consistent with a surgical implant.
- No mention of biological samples: IVDs typically involve testing biological samples (blood, urine, tissue, etc.) to diagnose or monitor a condition. There is no mention of any such testing in this description.
- Performance Studies: The performance studies listed (Static Bend Testing, Construct Fatigue Testing, Pyrogenicity Testing) are all related to the mechanical and biological safety of a surgical implant, not the diagnostic accuracy of a test.
Based on the provided information, the SALVATION Midfoot Reconstruction System is a surgical implant used for orthopedic procedures in the foot and ankle.
N/A
Intended Use / Indications for Use
The SALVATION™ Midfoot Reconstruction 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: intramedullary medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
Product codes
HWC
Device Description
The SALVATION Midfoot Reconstruction System, introduced as SALVATION Beams and Bolts in K140741, is being expanded to include the SALVATION Midfoot Nail. Designed to address the demands of advanced midfoot reconstruction, the subject nail features proximal threads and a distal cross screw to ensure fixation and rotational stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the 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)
The following evaluations were conducted to support the safety and efficacy of the SALVATION Midfoot Nail:
- Static Bend Testing
- -Construct Fatigue Testing
- -Pyrogencity Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
July 11, 2018
Re: K180024
Trade/Device Name: SALVATION Midfoot Nail Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 6, 2018 Received: June 8, 2018
Dear Alayne Melancon:
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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
SALVATION Midfoot Reconstruction System - Midfoot Nail Line Extension
Indications for Use (Describe)
The SALVATION™ Midfoot Reconstruction 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: intramedullary medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K180024 Page 1 of 2
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Membhis. TN 38117
901 867 997' mt.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 SALVATION Midfoot Reconstruction System – Midfoot Nail Line Extension.
(a)(1) MANUFACTURER IDENTIFICATION
Submitted By:
Contact Person:
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
Date:
December 20, 2017
Alayne Melancon Regulatory Affairs Specialist Office: (901)290-5986 Fax: (901)867-4190
(a)(2) SUBJECT DEVICE INFORMATION
Proprietary Name:
Common Name: Classification Name & Reference: Device Product Code & Panel:
SALVATION™ Midfoot Reconstruction System -Midfoot Nail Line Extension Smooth or Threaded Metallic Bone Fixation Fastener 21 CFR 888.3040 - Class II HWC - Orthopedic
(a)(3) PREDICATE DEVICE INFORMATION
SALVATION Beams and Bolts
(a)(4) DEVICE DESCRIPTON
The SALVATION Midfoot Reconstruction System, introduced as SALVATION Beams and Bolts in K140741, is being expanded to include the SALVATION Midfoot Nail. Designed to address the demands of advanced midfoot reconstruction, the subject nail features proximal threads and a distal cross screw to ensure fixation and rotational stability.
Image /page/3/Picture/21 description: The image contains the logo for Wright, a company that focuses on excellence. The logo features two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, bold letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
4
(a)(5) INTENDED USE
The SALVATION™ Midfoot Reconstruction 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: intramedullary medial column fusion and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject was designed with the same basic design features (material, geometry, and principle of operation) as the predicate device. A comparison of technological characteristics is shown below in Table 1.
| SUBJECT | PREDICATES | |
|---|---|---|
| SALVATION Midfoot Nail | SALVATION Beams and Bolts | |
| System | ||
| (K140741) | ||
| Material: | Type II Anodized Titanium | |
| Alloy per ASTM F136 | Type II Anodized Titanium | |
| Alloy per ASTM F136 | ||
| Central Shaft | ||
| Design: | Cannulated or Solid Core | Cannulated or Solid Core |
| Size Offerings: | Diameters: | |
| 8.0 mm | ||
| Lengths: | ||
| 60-160 mm | Diameters: | |
| 5.0 mm, 6.5 mm, 7.0 mm | ||
| Lengths: | ||
| 50-200 mm |
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The following evaluations were conducted to support the safety and efficacy of the SALVATION Midfoot Nail:
- Static Bend Testing
- -Construct Fatigue Testing
- -Pyrogencity Testing
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. 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.