(43 days)
No
The document describes a mechanical bone fixation device and its material properties, with no mention of AI or ML.
Yes
The device is indicated for interphalangeal fusion of the toes and fingers, which is a medical procedure to join bones, thereby providing a therapeutic effect.
No
The device is described as a bone fixation fastener used for interphalangeal fusion, which is a therapeutic rather than a diagnostic purpose.
No
The device is described as "threaded metallic bone fixation fasteners" and includes "superelastic and body temperature activated shape memory Nitinol," which are clearly hardware components. The submission focuses on a new passivation step and packaging change, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "interphalangeal fusion of the toes" and "interphalangeal fusion of fingers and toes." This describes a surgical procedure to join bones, not a test performed on samples from the body to diagnose a condition.
- Device Description: The device is described as "threaded metallic bone fixation fasteners." This is a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical implant used for bone fixation during a procedure.
N/A
Intended Use / Indications for Use
Smart Toe II: The Smart Toe II is indicated for interphalangeal fusion of the toes.
X Fuse: The X Fuse is indicated for interphalangeal fusion of fingers and toes.
Product codes
HTY
Device Description
The Smart Toe II & X Fuse, previously cleared in K112179, are threaded metallic bone fixation fasteners and include superelastic and body temperature activated shape memory Nitinol per ASTM F2063-18. The subject of the bundled submission introduces a new passivation step and packaging change.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Toes, fingers and toes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Non clinical laboratory testing was performed on the worst case subject staples to determine substantial equivalence. Testing demonstrated that the Intramedullary Bone Fastener (Smart Too II/X Fuse) system is equivalent in mechanical performance to the predicate device, the Memometal Intramedullary Bone Fastener (Smart Toe/X Fuse) [K112197] and reference device, the Memory Metal Staples, Easyclip (K122113).
The following testing was performed:
- Four-Point Bending Testing per ASTM F564
- Cyclic Potentiodynamic Polarization (Corrosion) Test per ASTM F2129 .
Key Metrics
Not Found
Predicate Device(s)
Memometal Intramedullary Bone Fastener (Smart Toe/X Fuse) (K112197)
Reference Device(s)
Memory Metal Staples, Easyclip (K122113)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health and Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
August 5, 2020
Stryker GmbH Jemin Dedania Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah. New Jersev 07430
Re: K201715
Trade/Device Name: Smart Toe II, X Fuse Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: June 22, 2020 Received: June 23, 2020
Dear Mr. Dedania:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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
1
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201715
Device Name Smart Toe II
Indications for Use (Describe) The Smart Toe II is indicated for interphalangeal fusion of the toes.
| 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
Indications for Use
510(k) Number (if known)
Device Name X Fuse
Indications for Use (Describe)
The X Fuse is indicated for interphalangeal fusion of fingers and toes.
| 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."
4
510(k) Summary
| Proprietary Name: | Smart Toe II & X Fuse |
|---|---|
| Common Name: | Intramedullary Bone Fastener |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | HTY |
| Device Class: | Class II |
| Sponsor: | Stryker GMBH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Jemin Dedania |
| Associate Manager Regulatory Affairs | |
| 325 Corporate Dr | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6461 | |
| Fax: (201) 831-3803 | |
| Date Prepared: | June 22, 2020 |
| Primary Predicate: | Memometal Intramedullary Bone Fastener (Smart Toe/X Fuse) |
| (K112197) | |
| Reference Devices: | Memory Metal Staples, Easyclip (K122113) |
Description
The Smart Toe II & X Fuse, previously cleared in K112179, are threaded metallic bone fixation fasteners and include superelastic and body temperature activated shape memory Nitinol per ASTM F2063-18. The subject of the bundled submission introduces a new passivation step and packaging change.
Indications for Use
The Smart Toe II is indicated for interphalangeal fusion of the toes.
The X Fuse is indicated for interphalangeal fusion of fingers and toes.
Summary of Technologies
5
A comparison of the systems demonstrated that the subject Smart Toe II & X Fuse are substantially equivalent to the Memometal Intramedullary Bone Fastener (Smart Toe/X Fuse) [K112197], in regards to intended use, material, design, and operational principles.
Non-Clinical Testing
Non clinical laboratory testing was performed on the worst case subject staples to determine substantial equivalence. Testing demonstrated that the Intramedullary Bone Fastener (Smart Too II/X Fuse) system is equivalent in mechanical performance to the predicate device, the Memometal Intramedullary Bone Fastener (Smart Toe/X Fuse) [K112197] and reference device, the Memory Metal Staples, Easyclip (K122113).
The following testing was performed:
- Four-Point Bending Testing per ASTM F564
- Cyclic Potentiodynamic Polarization (Corrosion) Test per ASTM F2129 .
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject Smart Toe II & X Fuse are substantially equivalent to the predicate Memometal Intramedullary Bone Fastener (Smart Toe/X Fuse).