(104 days)
Not Found
No
The summary describes a mechanical fixation system and its instruments, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is described as a "Hammertoe Fixation System" used for the "fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe," which are all medical treatments for specific conditions.
No
The device is described as a fixation system for osteotomies and reconstruction of the lesser toes, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it includes a PEEK implant and surgical instruments, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the ToeTac™ Hammertoe Fixation System 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.
- ToeTac™ Description: The description clearly states that the ToeTac™ system is a "threaded PEEK implant for bone fixation" and associated instruments used for "implant site preparation and delivery." This describes a surgical implant and its delivery system, which is used in vivo (within the body) for structural support and fixation.
- Intended Use: The intended use is for "fixation of osteotomies and reconstruction of the lesser toes." This is a surgical procedure performed directly on the patient's bones.
Therefore, the ToeTac™ Hammertoe Fixation System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Instratek ToeTac™ 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.
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
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)
Performance testing consisted of tests for axial pull out, torque, static and dynamic bend.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HammerFiX, K133636, Kirschner Wire, K112254
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Restore Surgical, LLC dba Instratek Mr. Jeff Seavey President 15200 Middlebrook Drive, Suite G Houston, Texas 77058
Re: K150443
Trade/Device Name: ToeTacTM 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: April 30, 2015 Received: May 1, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Jeff Seavey
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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 006: INDICATIONS FOR USE STATEMENT
510(k) Number: K150443
ToeTac™ Hammertoe Fixation System Device Name:
Indications for Use:
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.
X 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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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 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 281-890-8020
Phone:
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
President |
| Date summary prepared: | February 17, 2015 |
| Device trade name: | ToeTac™ 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 | HammerFiX, K133636
Kirschner Wire, K112254 |
| Description of the device: | The Instratek ToeTac™ 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. |
| 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 axial pull out, torque,
static and dynamic bend. |
| 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. |