(23 days)
No
The document describes a mechanical implant (nail system) and its intended use for surgical fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical properties like fatigue testing.
Yes
Facilitating arthrodesis to treat severe foot/ankle deformity and arthritis directly addresses and improves a pathological condition, which is a therapeutic action.
No
Explanation: The device, the VALOR® Ankle Fusion Nail System, is described as an implant intended to facilitate tibiotalocalcaneal arthrodesis. It is a surgical device used for fusion, not for diagnosing conditions.
No
The device description explicitly states that the device is an "Ankle Fusion Nail System" and is manufactured from "titanium alloy," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (an ankle fusion nail system) intended to be surgically implanted to stabilize bones in the ankle and foot. It is used to treat structural problems and deformities, not to analyze biological samples.
The device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture nonunions. Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Product codes
HSB
Device Description
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the existing VALOR® Ankle Fusion Nail System and will be offered in multiple lengths. The implants will be manufactured from titanium alloy.
The design features of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths are substantially equivalent to the design features of other devices 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was shown through fatigue testing. The results of the test show that the subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths can be expected to perform at least as well as legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VALOR® Ankle Fusion Nail System (K090857)
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
MAR 2 3 2011
KIDSS2
تم
i.
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 VALOR® Ankle Fusion Nail System - Extended Screw Lengths.
Wright Medical Technology, Inc.
A.1. Submitted By:
5677 Airline Rd
Arlington, TN 38002
| Date: | February 25, 2010 |
|---|---|
| Contact Person: | Ryan Bormann |
| Regulatory Affairs Specialist | |
| (901) 867 - 4409 | |
| A.2. Proprietary Name: | VALOR® Ankle Fusion Nail System - Extended Screw Lengths |
| Common Name: | Ankle Fusion Nail |
| Device Classification Regulation: | 21 CFR 888.3020--Class II |
| Device Product Code & Panel: | HSB Rod, Fixation, Intramedullary and Accessories |
| 87 Orthopedics | |
| A.3. Predicate Device: | VALOR® Ankle Fusion Nail System (K090857) |
A.4. Device Description
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the existing VALOR® Ankle Fusion Nail System and will be offered in multiple lengths. The implants will be manufactured from titanium alloy.
The design features of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths are substantially equivalent to the design features of other devices previously cleared for market.
A.5. Intended Use
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture nonunions. Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
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A.6. Technological Characteristics Comparison
The subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths and the legally marketed predicate VALOR® Ankle Fusion Nail System have the same indications, materials and design.
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths differ from the legally marketed predicate VALOR® Ankle Fusion Nail System in overall length.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence was shown through fatigue testing. The results of the test show that the subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths can be expected to perform at least as well as legally marketed predicate devices.
The safety and effectiveness of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through bench testing and design characteristics. The materials and indications are similar and no new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is oriented to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Ryan Bormann 5677 Airline Road Arlington, TN 38002
MAR 2 3 2011
Re: K110552
Trade/Device Name: VALOR Ankle Fusion Nail System – Extended Screw Lengths Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: February 25, 2011 Received: February 28, 2011
Dear Mr. Bormann:
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
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Page 2 - Mr. Ryan Bormann
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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
Image /page/3/Picture/4 description: This image contains a letter from Mark N. Melkerson, Director, with a URL at the top: http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. The letter is signed, and the signature includes the title "CLINICAL DIRECTOR". The letter is likely a formal communication from the FDA.
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_ K110552
Device Name: _VALOR® Ankle Fusion Nail System - Extended Screw Lengths
Indications For Use:
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign-Off) (Division Sign-on-on), Orthopedic, and Restorative Devices
510(k) Number K110552