(146 days)
No
The summary describes a mechanical fixation system and instrumentation, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for fixation and reconstruction of lesser toes following corrective procedures, which addresses a medical condition (hammertoe, claw toe, and mallet toe) and therefore has a therapeutic purpose.
No
Explanation: The device description clearly states its purpose is for "fixation of osteotomies and reconstruction," which are treatment procedures, not diagnostic ones. The device is an implant for bone fixation.
No
The device description explicitly states it includes a threaded PEEK implant and a set of instruments, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the ToeTac™ 10° Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of osteotomies and reconstruction of lesser toes following correction procedures. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a threaded PEEK implant and associated instruments for bone fixation and delivery. This is a physical implant and surgical tools, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through laboratory tests, or providing information for diagnosis, monitoring, or screening based on sample analysis.
Therefore, the ToeTac™ 10° Fixation System falls under the category of a surgical implant and instrument system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.
Product codes
HWC
Device Description
The Instratek ToeTac™ 10° Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver, as well as a single packaged implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes
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)
Performance testing consisted of tests for pull out, torque and static and dynamic bend strength. The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ToeTac™ Hammertoe Fixation System, K150443, Kirschner Wire, K112254
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.
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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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Restore Surgical LLC Dba Instratek Jeff Seavey President 15200 Middlebrook Dr., Suite G Houston, Texas 77058
November 22, 2016
Re: K161778
Trade/Device Name: ToeTac™ 10° Hammertoe Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 17, 2016 Received: November 18, 2016
Dear Mr. Seavey:
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 devicerelated 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/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
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Indications for Use
510(k) Number (if known) K161778
Device Name ToeTac™ 10° Fixation System
Indications for Use (Describe)
The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.
| 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)
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SECTION 007: 510(K) SUMMARY
| Submission Correspondent
and Owner: | Restore Surgical LLC, dba Instratek
15200 Middlebrook Dr., Suite G
Houston, TX 77058
USA
Phone: 281-890-8020
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
President |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date summary prepared: | June 28, 2016 |
| Device trade name: | ToeTac™ 10° Hammertoe Fixation System |
| Device classification name: | Bone Screw, Fixation, fastener |
| Classification: | Class II |
| Product Code: | HWC |
| Regulation/Description: | 880.3040, Smooth or threaded metallic bone fixation |
| Predicate Devices | ToeTac™ Hammertoe Fixation System, K150443
Kirschner Wire, K112254 |
| Description of the device: | The Instratek ToeTac™ 10° Hammertoe Fixation System includes a
threaded PEEK implant for bone fixation and a set of instruments
used for implant site preparation and delivery. The device is offered
in a sterile packaged kit that contains the implant, bone preparation
instrumentation and a driver, as well as a single packaged implant. |
| Intended use of the device: | The ToeTac™ Hammertoe Fixation System indicated for the
fixation of osteotomies and reconstruction of the lesser toes
following correction procedures for hammertoe, claw toe, and
mallet toe. |
| Technological
characteristics: | The proposed device has the same technological characteristics as
the predicate devices. |
| Testing: | Performance testing consisted of tests for pull out, torque and static
and dynamic bend strength. |
| Conclusions: | The results of the comparison of design, materials, intended use and
technological characteristics demonstrate that the device is as safe
and effective as the legally marketed predicate devices. |