(57 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of a physical implant for hammertoe fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for fixation of osteotomies and reconstruction of lesser toes following hammertoe, claw toe, and mallet toe correction procedures, which are therapeutic interventions.
No
The device is described as an implant system for fixation and reconstruction of lesser toes following correction procedures, not for diagnostic purposes.
No
The device description clearly states it is a "single piece titanium device" and mentions "Cannulated Implants" and "k-wires," indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The PHALINX™ Hammertoe System is a surgical implant designed for the fixation of bones in the lesser toes. It is a physical device implanted into the body.
- Intended Use: The intended use is for the surgical fixation and reconstruction of toe deformities. This is a therapeutic procedure, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant used for treatment, not a device used to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The PHALINX™ Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PHALINX™ Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTY
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a gamma sterilized version of the PHALINX Hammertoe system. The subject PHALINX® Hammertoe System implants are designed to facilitate fixation of osteotomies and reconstruction of the lesser toes. The implants have barbed proximal and interrupted distal threads fixation features and are offered in multiple sizes. The subject PHALINX hammertoe implant is single piece titanium device offered in straight cannulated and angled 10° solid options and remains identical to the predicate in design. The subject cannulated hammertoe implanted temporarily with k-wires (0.9, 1.1, 1.4 mm) to stabilize outlying joints. These k-wires were originally cleared under K 142585 and a minor modification to the length of the k-wire is being made in this submission.
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 (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Pyrogenicity testing was conducted using the bacterial endotoxins test on the subject device per ANSI/AAMI ST 72.
- Engineering analysis was provided to evaluate MR compatibility of the subject device per ASTM . F2182 (RF Heating), ASTM F2062 ()/ASTM F2213 (Induced Force /Induced Torque), and ASTM F2119 (Image Artifact).
Clinical Testing:
Clinical testing was not required for this submission.
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.
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.
0
November 16, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Wright Medical Technology, Inc. Michael Mullins Staff Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 37117
Re: K212996
Trade/Device Name: Sterile PHALINX Hammertoe System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HTY Dated: September 17, 2021 Received: September 20, 2021
Dear Michael Mullins:
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 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
1
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) 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 Advice (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,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212996
Device Name Sterile PHALINX Hammertoe System
Indications for Use (Describe)
The PHALINX™ Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PHALINX™ Hammertoe Fixation System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
| 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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510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Sterile PHALINX® Hammertoe System.
| Submitted by: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Mullins
Staff Regulatory Affairs Specialist
Phone: 901-867-4142
Fax: 901-867-4190 |
| Date Prepared: | 16-November-2021 |
| Proprietary Name: | Sterile PHALINX Hammertoe System |
| Primary Product Code-Device Panel:
Primary Common Name: | HWC - Orthopedic
Screw, Fixation, Bone |
| Secondary Product Code-Device Panel:
Secondary Common Name: | HTY - Orthopedic
Pin, Fixation, Smooth |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 – Class II |
| Device Class: | Class II |
| Primary Predicate: | K150252: PHALINX Hammertoe |
| Additional Predicates: | N/A |
| Reference Device: | K203832: FUSEFORCE™ Flex Dynamic Compression System
K140148: PROTOE Hammertoe Fixation System |
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a gamma sterilized version of the PHALINX Hammertoe system. The subject PHALINX® Hammertoe System implants are designed to facilitate fixation of osteotomies and reconstruction of the lesser toes. The implants have barbed proximal and interrupted distal threads fixation features and are offered in multiple sizes. The subject PHALINX hammertoe implant is single piece titanium device offered in straight cannulated and angled 10° solid options and remains identical to the predicate in design. The subject cannulated hammertoe implanted temporarily with k-wires (0.9, 1.1, 1.4 mm) to stabilize outlying joints. These k-wires were originally cleared under K 142585 and a minor modification to the length of the k-wire is being made in this submission.
4
Indications for Use
The PHALINX® Hammertoe System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PHALINX® Hammertoe System can be used with k-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
Technological Characteristics Comparison
The subject PHALINX hammertoe implants are identical to the predicate in implant design, material, and intended use. Further, the subject k-wires are identical to the predicate k-wires except for being longer. Lastly, the predicate system is offered nonsterile while the subject system is offered gamma sterilized.
Non-Clinical Testing
- Pyrogenicity testing was conducted using the bacterial endotoxins test on the subject device per ANSI/AAMI ST 72.
- Engineering analysis was provided to evaluate MR compatibility of the subject device per ASTM . F2182 (RF Heating), ASTM F2062 ()/ASTM F2213 (Induced Force /Induced Torque), and ASTM F2119 (Image Artifact).
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject has the same Indications for Use as the predicate device, and equivalent technological characteristics to the predicate device. Therefore, the information provided in this submission demonstrates substantial equivalence of the subject device to the predicate device.