(197 days)
No
The device description and performance studies focus on the mechanical properties and intended use of a surgical implant, with no mention of AI or ML capabilities.
Yes
This device is an implantable medical device used for arthrodeses, which is a therapeutic procedure to fuse joints.
No
The device description clearly states its purpose as an implant for arthrodeses, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it consists of "intramedullary implants" made of "Titanium alloy," which are physical hardware components, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Footmotion Hammer Toe range consists of intramedullary implants designed for surgical procedures (arthrodeses) within the body.
- Intended Use: The intended use is for a surgical procedure to fuse bones in the toes, not for testing samples outside the body.
The device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults. The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization. Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3). Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal arthrodeses of lesser toes
Indicated Patient Age Range
adults
Intended User / Care Setting
health care professionals
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)
Non-clinical Test Summary: The following tests were conducted: - Flexion tests. - Pull out tests. Clinical Test Summary: No clinical studies were performed.
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.
K070598, K112197, K101165, K122031
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.
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.
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March 2, 2018
Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K172485
Trade/Device Name: Footmotion HammerToe Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: February 16, 2018 Received: February 20, 2018
Dear Mr. Webb:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172485
Device Name
Footmotion HammerToe
Indications for Use (Describe)
The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of the letters "nct" in a circle, with the "t" in a different color (reddish-pink) and an arrow pointing upwards. The company name is written in capital letters below the circle.
510 (k) Summary for the Footmotion HammerToe range
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the HammerToe system.
Summary preparation date: March, 2017
| 1. Submitter: | Contact Person: |
|---|---|
| NEWCLIP TECHNICS | |
| P.A. de la Lande Saint Martin | |
| 45 rue des Garottières | |
| F-44115 Haute-Goulaine - | |
| France | |
| Telephone: (33) 2 28 21 37 12 | J.D. Webb |
| The OrthoMedix Group, Inc. | |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| Telephone: 512-388-0199 | |
| 2. Trade name: | Footmotion HammerToe |
| Common Name: | Smooth or threaded metallic bone |
| fixation fastener. | |
| Product code: | HTY |
| Classification Name: | Smooth or threaded metallic bone |
| fixation fastener | |
| (21 CFR part. 888.3040) |
3. Primary predicate or legally marketed devices which are substantially equivalent:
- Memometal Intra-medullary Bone Fastener of MEMOMETAL . TECHNOLOGIES (K070598 / K112197)
K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.
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Image /page/4/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters "nct" in a circle, with the "t" having an upward-pointing arrow as part of its design. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.
Secondary predicate or legally marketed devices which are substantially equivalent:
- Pro-Toe Vo Hammertoe Implant System of WRIGHT MEDICAL . TECHNOLOGIES (K101165)
- Nextra Ti Hammertoe Correction System of NEXTREMITY . SOLUTION, INC (K122031)
Reference predicate or legally marketed devices which are substantially equivalent:
- Trim-it drill pin of ARTHREX (K050259) .
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- Description of the device: The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults.
The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization.
- Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3).
- Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
5. Substantial equivalence claimed to predicate devices:
The Footmotion HammerToe range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.
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Image /page/5/Picture/1 description: The image shows a logo for a company called "NEWCLIP-TECHNICS". The logo features the letters "nct" inside of a circle. The "t" in "nct" has a red arrow pointing upwards. The company name is written in all caps below the circle.
6. Intended use:
The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.
7. Non-clinical Test Summary:
The following tests were conducted:
- Flexion tests .
- Pull out tests .
8. Clinical Test Summary:
No clinical studies were performed.
9. Conclusions Non-clinical and Clinical:
Newclip considers the Footmotion HammerToe range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.