(91 days)
No
The summary describes a purely mechanical implant for bone fixation and makes no mention of AI or ML.
Yes
The device is described as "metallic devices intended to stabilize two bone fragments until bone fusion" for "fixation of osteotomies and reconstruction of the lesser toes," which directly addresses a medical condition (hammertoe, claw toe, mallet toe) for therapeutic purposes.
No
Explanation: The device is intended for the fixation and stabilization of bone fragments during fusion, not for diagnosing conditions.
No
The device description clearly states it is a metallic implant made of titanium alloy, which is a hardware component, not software.
Based on the provided information, this device 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 directly on the patient's body.
- Device Description: The device is a metallic implant intended to stabilize bone fragments. This is a physical implant used within the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens.
The device described is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Product codes
HWC
Device Description
The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.
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
The following mechanical tests were performed:
- o Static bending test
- o Dynamic bending test
- o Axial pull-out test
The results of these tests indicate that the Interphalangeal Joint Fusion Devices are as strong or stronger than predicate devices.
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name reads "U.S. Food & Drug Administration".
August 28, 2019
Neosteo % Mr. J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4314 W. 3800 S. West Haven, Utah 84401
Re: K191424
Trade/Device Name: Interphalangeal Joint Fusion Device Range Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 8, 2019 Received: August 12, 2019
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. 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
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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,
for RPJ
Ronald Jean, Ph.D. 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
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Indications for Use
510(k) Number (if known) K191424
Device Name
Interphalangeal Joint Fusion Device Range
Indications for Use (Describe)
The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ly Prescription Use (Part 21 CFR 801 Subpart D) | _ Over-The-Counter Use (21 CFR 801 Subp |
lion 300 (Part 21 SFR 301 Support B)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
l. SUBMITTER'S INFORMATION
A. 510(k) Owner
NEOSTEO Mallève 2A 1 Boulevard Jean Moulin 44 100 Nantes, France Tel: +33 (0)2 36 56 96 70 Fax: +33 (0)2 51 70 61 34
B. Contact Person
JD Webb The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 Tel: 512 590 5810 Email: jdwebb@orthomedix.net
C. Date of Preparation of the 510(k) Summary
8th August 2019
DEVICE IDENTIFICATION II.
| Trade or proprietary name | Interphalangeal Joint Fusion Device Range |
|---|---|
| Common or usual name | Interphalangeal Joint Fusion Device Range |
| Classification regulation | 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Proposed Regulatory Class | Class II |
| Panel | 87 "Orthopedic" |
| Product code | HWC |
| Primary Predicate Device | HammerFix® (K133636) from Extremity Medical |
| ProToe® (K101165) from Wright Medical | |
| Secondary Predicate Devices | Kirschner and Guide Wires (K100736) from SMT Schilling Metalltechnik GmbH |
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Image /page/4/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller font.
510(k) Summary
III. DEVICE DESCRIPTION
The Interphalangeal Joint Fusion Device Range consists of metallic devices intended to stabilize two bone fragments until bone fusion. They are available in several lengths and angulations. All the implants are made of titanium alloy.
A. Materials
Titanium alloy per ISO 5832-3 / ASTM F136.
IV. INDICATIONS FOR USE
The Interphalangeal Joint Fusion Devices are intended for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
| Intended Use | The Interphalangeal Joint Fusion Devices and all the predicates have
similar intended uses. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | The Interphalangeal Joint Fusion Devices are fabricated of the same
material as the predicate devices. |
| Design
Features/Functions | The Interphalangeal Joint Fusion Devices and the cited predicate
devices share similar basic design features and functions. |
| Dimensions | The Interphalangeal Joint Fusion Devices are dimensionally similar to the
cited predicate devices. |
| Sterilization | The Interphalangeal Joint Fusion Devices are provided sterile as are the
cited predicate devices. |
| Performance
Specification | Mechanical testing confirmed the Interphalangeal Joint Fusion Devices
demonstrated as good or better performances than the cited predicate
devices under the same test conditions. |
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE V.
VI. NON-CLINICAL TEST SUMMARY
The following mechanical tests were performed:
- o Static bending test
- o Dynamic bending test
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Image /page/5/Picture/1 description: The image shows the logo for Neosteo. The logo consists of an orange spiral design on the left and the word "neosteo" in orange on the right. Below the word "neosteo" is the phrase "EFFICIENT MOBILITY" in a smaller, lighter font.
510(k) Summary
o Axial pull-out test
The results of these tests indicate that the Interphalangeal Joint Fusion Devices are as strong or stronger than predicate devices.
CLINICAL TEST SUMMARY VII.
No clinical studies were performed.
CONCLUSIONS NON-CLINICAL AND CLINICAL VIII.
NEOSTEO considers the Interphalangeal Joint Fusion Devices to be equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in principles of operation, technology, materials and indications for use.