(37 days)
No
The document describes a surgical implant (nail and screws) and its intended use for hindfoot fusion. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The focus is on the material, dimensions, and mechanical performance of the physical device.
Yes.
The device is intended to facilitate tibiotalocalcaneal arthrodesis for various medical conditions, indicating a direct role in treating or mitigating a disease or condition.
No
This device is a surgical implant (nail system) used to facilitate tibiotalocalcaneal arthrodesis, which is a fusion procedure. It is not used for diagnosing medical conditions.
No
The device description explicitly states that the system includes nails and screws manufactured from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (nails and screws made of titanium alloy) intended to be placed inside the body to facilitate bone fusion in the hindfoot.
- Intended Use: The intended use clearly states the device is for facilitating tibiotalocalcaneal arthrodesis (fusion of bones) for various conditions affecting the hindfoot. This is a surgical procedure, not a diagnostic test performed on a specimen.
The description of the VALOR® Hindfoot Fusion Nail System aligns with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VALOR® Hindfoot Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis in any of the following indications:
- · Severe foot/ankle deformity.
· Osteoarthritis.
· Instability and skeletal defects after tumor resection,
· Neuro-arthropathic deformity or Charcot deformity,
· Avascular necrosis of the talus,
· Revision of a failed joint replacement or failed ankle fusion,
· Distal tibia fracture and non-unions,
· Rheumatoid arthritis and pseudoarthosis
Product codes
HSB
Device Description
The design features of the subject VALOR® Hindfoot Fusion Nail System are summarized below:
- . Nails and screws are manufactured from titanium alloy.
- Nails are available in two diameters and a range of lengths.
- Screws are available in one diameter and a range of lengths.
The subject nail in this Special 510(k) is a line extension of the system to include a 300mm length nail. The design features of the VALOR® Hindfoot Fusion Nail System are substantially equivalent to the design and features of other the devices in this product family previously cleared for market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot/ankle, tibiotalocalcaneal
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2014
Wright Medical Technology, Inc. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K142602
Trade/Device Name: VALOR® Hindfoot Fusion Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 26, 2014 Received: September 30, 2014
Dear Ms. Val Myles:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Val Myles
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 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. 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 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 vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142602
Device Name VALOR HINDFOOT FUSION NAIL SYSTEM
Indications for Use (Describe)
The VALOR® Hindfoot Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis in any of the following indications:
- · Severe foot/ankle deformity.
· Osteoarthritis.
· Instability and skeletal defects after tumor resection,
· Neuro-arthropathic deformity or Charcot deformity,
· Avascular necrosis of the talus,
· Revision of a failed joint replacement or failed ankle fusion,
· Distal tibia fracture and non-unions,
· Rheumatoid arthritis and pseudoarthosis
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) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
3
Headquarters Wright Medical Technology, Inc.
023 Cherry Road Memphis, TN 38117
mt.com
Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, sans-serif font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray, sans-serif font.
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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the Use of the VALOR® Hindfoot Fusion Nail System.
| 1. Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
|---|---|
| ------------------ | ---------------------------------------------------------------------- |
Date:
Contact Person:
Val Myles Regulatory Affairs Specialist
Office (901) 867-4120 (901) 867-4190 Fax
September 12, 2014
- Proprietary Name:
Common Name:
Ankle Fusion Nail
VALOR® Hindfoot Fusion Nail System
Classification Name and Reference: 21 CFR 888.3020- Class II
Device Product Code, Device Panel: HSB: Rod, Fixation, Intramedullary and Accessories
- Predicate Device: K090857 VALOR® Ankle Fusion Nail System
4. Device Description
o
o
The design features of the subject VALOR® Hindfoot Fusion Nail System are summarized below:
- . Nails and screws are manufactured from titanium alloy.
- Nails are available in two diameters and a range of lengths.
Screws are available in one diameter and a range of lengths.
The subject nail in this Special 510(k) is a line extension of the system to include a 300mm length nail. The design features of the VALOR® Hindfoot Fusion Nail System are substantially equivalent to the design and features of other the devices in this product family previously cleared for market.
4
ട്. Intended Use
The VALOR® Hindfoot Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis in any of the following indications:
- Severe foot/ankle deformity,
- Osteoarthritis, ●
- Instability and skeletal defects after tumor resection, ●
- Neuro-arthropathic deformity or Charcot deformity,
- Avascular necrosis of the talus, ●
- Revision of a failed joint replacement or failed ankle fusion, ●
- Distal tibia fracture and non-unions, ●
- . Rheumatoid arthritis and pseudoarthosis
6. Technological Characteristics Comparison
The VALOR® Hindfoot Fusion 300mm Nail System compared the legally marketed predicate device is 50mm longer. No changes have been made to any other dimensions or materials.
7. Substantial Equivalence- Non-Clinical Evidence
The subject 300mm nails do not provide a new worst case. From testing parameters performed on the predicate device, the 300mm nail will perform the same as the predicate in worst case testing because the working length and diameters have remained unchanged from the 250mm to 300mm nails.
Substantial Equivalence- Clinical Evidence 8.
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.