(64 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "tibiotalocalcaneal fusions" to treat various medical conditions like arthritis, arthrosis, non-union, and deformities, which are specific therapeutic interventions.
No
The device is described as an Intramedullary Fixation Rod intended for tibio-talo-calcaneal fusions, which is a therapeutic rather than diagnostic function. It is a surgical implant used for rigid fixation.
No
The device description clearly states that the DynaNail™ is a sterile, single-use titanium Intramedullary Fixation Rod, which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fusing bones in the ankle and foot. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "sterile, single use titanium Intramedullary Fixation Rod" and associated screws. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:
- Post-traumatic and degenerative arthritis.
- Post-traumatic or primary arthrosis involving both ankle and subtalar joints.
- Revision after failed ankle arthrodesis with subtalar involvement.
- Failed total ankle arthroplasty.
- Non-union ankle arthrodesis.
- Rheumatoid hindfoot.
- Absent Talus (requiring tibiocalcaneal arthrodesis).
- Avascular necrosis of the talus.
- Neuroarthropathy or neuropathic ankle deformity.
- Neuromuscular disease and severe deformity.
- Osteoarthritis.
- Charcot Foot.
- Previously infected arthrosis, second degree.
Product codes
HSB
Device Description
The proposed DynaNail™ is sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is available in 10, 11, and 12mm diameters and lengths of 180mm, 220mm, 260mm, and 300mm. The DynaNail is implanted with a deployment frame and fixation screws. The fixation screws are single use 5mm titanium headed and headless screws. The screws are available in lengths that range from 20 to 110mm. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same fashion as existing nails.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, subtalar
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Functional performance analysis of the predicate and proposed DynaNaiI™ and VersaNail™ were conducted per IM.v4 and ASTM F 1264-03. Analysis substantiates the statement that the proposed device performs equivalently to the predicate devices.
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
§ 888.3020 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/0 description: The image shows the text "MEDSHAPE SOLUTIONS" in a bold, sans-serif font. The word "MEDSHAPE" is on the top line, and the word "SOLUTIONS" is on the bottom line. There is a horizontal line separating the two words. The text is black and the background is white.
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FEB 2 9 2012
510(k) Summary
510(k) Number: K113828
February 22, 2012 Date Prepared:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
A. Submitter:
MedShape Solutions, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact:
Jeremy Blair Project Manager (678) 235-3319(direct) (404) 249-9158 (fax) Jeremy. Blair@MedShape.com
். Device Information:
| Trade Name: | DynaNail Ankle Arthrodesis Nail |
|---|---|
| Common Name: | Ankle Nail |
- D. Classification Name: Intramedullary Fixation Rod HSB 21 CFR 888.3020
- Predicate Device(s): ﻧﯩ
DynaNail™ Ankle Nail, Intramedullary Fixation Rod, K101934 DePuy Ace VersaNail™Intramedullary Fixation Rod, K023115
- F. Physical Description:
The proposed DynaNail™ is sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is available in 10, 11, and 12mm diameters and lengths of 180mm, 220mm, 260mm, and 300mm. The DynaNail is implanted with a deployment frame and fixation screws. The fixation screws are single use 5mm titanium headed and headless screws. The screws are available in lengths that range from 20 to
1
110mm. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same fashion as existing nails.
். Indications for Use:
The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:
- Post-traumatic and degenerative arthritis. .
- Post-traumatic or primary arthrosis involving both ankle and subtalar . ioints.
- Revision after failed ankle arthrodesis with subtalar involvement. ●
- Failed total ankle arthroplasty. ●
- Non-union ankle arthrodesis. .
- Rheumatoid hindfoot. .
- Absent Talus (requiring tibiocalcaneal arthrodesis). ●
- Avascular necrosis of the talus. ●
- Neuroarthropathy or neuropathic ankle deformity. ●
- Neuromuscular disease and severe deformity.
- Osteoarthritis.
- Charcot Foot.
- Previously infected arthrosis, second degree .
H. Comparison of Technological Characteristics:
The DynaNail is substantially equivalent in design, function and intended use to the following predicate devices:
DynaNail™ Ankle Nail. Intramedullary Fixation Rod. K101934 DePuy Ace VersaNail™ Intramedullary Fixation Rod, K023115
The construction of the DynaNail™ body is equivalent to that of the previously cleared DynaNail™ device as well as the VersaNail™ device. The manufacture and processing of all patient contacting materials are identical to the predicate DynaNail™ K101934. The DynaNail™ device is offered in comparable diameters (10-12mm) and lengths (180-300mm) to the predicate VersaNail™. The DynaNail™ utilizes the same deployment method and external frame technology as the predicate DynaNaiI™ K101934
Image /page/1/Picture/20 description: The image shows the logo for MEDSHAPE SOLUTIONS. The word "MEDSHAPE" is in large, bold, sans-serif font, with a line underneath it. Below the line, the word "SOLUTIONS" is in a smaller, sans-serif font.
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K113828 3/3
Functional performance analysis of the predicate and proposed DynaNaiI™ and VersaNail™ were conducted per IM.v4 and ASTM F 1264-03. Analysis substantiates the statement that the proposed device performs equivalently to the predicate devices.
Jeremy Blair Project Manager
Image /page/2/Picture/3 description: The image shows the logo for MEDSHAPE SOLUTIONS. The word "MEDSHAPE" is in large, bold, sans-serif font, with each letter capitalized. A horizontal line underlines the word. Below the line, the word "SOLUTIONS" is printed in a smaller, sans-serif font, also with all capital letters.
3
Image /page/3/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.
MedShape Solutions, Inc. % Mr. Jeremy Blair 1575 Northside Drive, Suite 440 Atlanta. Georgia 30318
FEB 2 9 2012
Re: K113828
Trade/Device Name: DynaNail Ankle Arthrodesis Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 22, 2011 Received: December 28, 2011
Dear Mr. Blair:
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
4
Page 2 - Mr. Jeremy Blair
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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K |13828
Device Name: DynaNail™ Ankle Arthrodesis Nail
Indications for Use:
The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:
- Post-traumatic and degenerative arthritis. .
- Post-traumatic or primary arthrosis involving both ankle and subtalar joints. .
- Revision after failed ankle arthrodesis with subtalar involvement. �
- Failed total ankle arthroplasty. .
- Non-union ankle arthrodesis. .
- Rheumatoid hindfoot. .
- Absent Talus (requiring tibiocalcaneal arthrodesis). ●
- Avascular necrosis of the talus. �
- Neuroarthropathy or neuropathic ankle deformity. �
- Neuromuscular disease and severe deformity. .
- . Osteoarthritis.
- Charcot Foot. .
- Previously infected arthrosis, second degree .
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K113828 510(k) Number_