(28 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of the implants and instruments, with no mention of AI or ML.
Yes.
The device is used for small bone fusion, fractures, and inter-digital fusion, which are therapeutic interventions.
No
The device is described as an implantable system for bone fusion and correction, not for identifying or diagnosing medical conditions.
No
The device description clearly states it consists of physical components (intramedullary bone screws, taper lock pin, instruments) made of titanium and cobalt-chrome alloys, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery." These are physical implants and surgical tools.
- 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 about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to treat a physical condition directly.
N/A
Intended Use / Indications for Use
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
Product codes
HWC
Device Description
The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers, toes and small bones
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
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis
- . Mechanical Testing: static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout and disassembly
- A Kinetic Chromogenic LAL Test on the finished product which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with a wing-like shape extending from the top profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Arthrosurface, Inc. Ms. Dawn Wilson VP. Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K170350
Trade/Device Name: ToeMATE® Hammertoe Correction 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 1, 2017 Received: March 3, 2017
Dear Ms. Wilson:
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 and Part 809); 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
1
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 and Part 809), 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" (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 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/ResourcesforYou/Industry/default.htm.
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
510(k) Number (if known) K170350
Device Name
ToeMATE® Hammertoe Correction System
Indications for Use (Describe)
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
Type of Use (Select one or both, as applicable)
X 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
| Special 510(k): Device Modification
| ToeMATE® Hammertoe Correction System | |
|---|---|
| 510(k) Owner: | Arthrosurface, Inc. |
| 28 Forge Parkway | |
| Franklin, MA 02038 | |
| Tel: 508.520.3003 | |
| Fax: 508.528.4604 | |
| Contact: | Dawn Wilson |
| VP, Quality & Regulatory | |
| Tel: 508.520.3003 | |
| Fax: 508.528.4604 | |
| dwilson@arthrosurface.com | |
| Establishment Registration | |
| Number: | 3004154314 |
| Date of Preparation: | February 01, 2017 |
| Confidentiality: | Reference Section 3 |
| Proprietary Name: | |
| Common Name: | ToeMATE® Hammertoe Correction System |
| Screw, Fixation, Bone | |
| Regulation Description: | |
| Regulation Number: | |
| Device Class: | |
| Review Panel: | |
| Product Code: | Smooth or Threaded Metallic Bone Fixation Fastener |
| 21 CFR 888.3040 | |
| Class II | |
| Orthopedic | |
| HWC |
Indications for Use
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
4
Device Description
The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.
Substantial Equivalence Information
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the additional sizes for the ToeMATE® Hammertoe Correction System are substantially equivalent in indications and design principles to the following predicate and/or reference devices, which have been previously cleared by the FDA:
Primary Predicate
K130859 Arthrosurface, Inc.'s Hammertoe Correction System
Additional Predicate(s)
K101165 Wright Medical PRO-TOE™ VO Hammertoe Implant System K120645
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
- Has the same Indications for Use,
- Uses the same operating principle,
- ls manufactured using common orthopedic implant materials,
- Utilizes similar instrumentation for proper placement,
- ls packaged and sterilized using the same materials and processes.
In support of this submission, the following non-clinical tests and/or analysis were performed for the Subject Device:
- Device Comparative Analysis
- . Mechanical Testing: static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout and disassembly
- A Kinetic Chromogenic LAL Test on the finished product which meets the standard limit of 0.5 EU/mL or 20 EU/ Device per United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar
5
Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.
Conclusions
The results have demonstrated that the ToeMATE® Hammertoe Correction System is substantially equivalent to the predicate devices.