(102 days)
Not Found
No
The document describes a mechanical implant and surgical instruments, with no mention of AI/ML capabilities or data processing.
Yes
The device is indicated for fixation of osteotomies and reconstruction of lesser toes following correction procedures, which are therapeutic interventions.
No
The device is described as an implantable medical device used for the fixation of osteotomies and reconstruction of lesser toes, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components (implant, instrumentation, bone awl) made of materials like suture, Nitinol, and PEEK, indicating it is a hardware medical device.
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 surgical procedures. This is a surgical implant used in vivo (within the body) to provide structural support and promote healing.
- Device Description: The device is comprised of physical components (implant, instrumentation, awl) designed for surgical implantation. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.
Product codes
HWC, HTY
Device Description
The ProxiFuse Hammer Toe Device consists of three components: 1) the implant, 2) deployment instrumentation, and 3) bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves multiple functions: 1) shifting of the PEEK Body and 2) applying tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint (PIPJ).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes, middle phalanx, proximal interphalangeal joint (PIPJ)
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
Bench testing was performed to assure substantial equivalence to a predicate device and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. No clinical data were needed to support the safety and effectiveness of the subject device.
Bench testing consisted of the following:
- USP Suture Testing
- Pullout/Dis-assembly Testing
- Static Bending Testing
- Fatigue Bending Testing
- Bench and Cadaver Testing
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.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2014
Cartiva, Incorporated % Ms. Rachel Kennedy Principal Advisor Regulatory and Clinical Research Institute 5353 Wayzata Blvd, Suite 505 Minneapolis, Minnesota 55416
Re: K142490
Trade/Device Name: ProxiFuse Hammer Toe Device 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 15, 2014 Received: September 17, 2014
Dear Ms. Kennedy:
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 - Ms. Rachel Kennedy
forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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.
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 yours. Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142490
Device Name ProxiFuse Hammer Toe Device
Indications for Use (Describe)
The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes f following correction procedures for hammertoe, claw toe, and mailet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.
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)
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 l he to review instructions, search existing data sources, gather and maintain the data needed and complete time to review the collection. 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
Traditional 510(k) Summary
| Submitted by: | Cartiva, Inc.
6120 Windward Pkwy
Suite 220
Alpharetta, GA 30005 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Rick Knostman
Vice President, Operations
Cartiva, Inc.
Tel: 770-754-3800
Email: rknostman@carticept.com |
| Date of Summary: | November 25, 2014 |
| Device Trade Name: | ProxiFuse Hammer Toe Device |
| Model Number: | PRF-01 |
| Product Code: | HWC, HTY |
| Common or Usual Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 CFR
888.3040) |
| Predicate Device(s): | Pro-Toe VO Hammertoe Implant System, K101165
NEWDEAL K WIRE, K022599
Arthrex Bio-Pin (marketed as Trim-It Pin), K050259 |
| Device Description: | The ProxiFuse Hammer Toe Device consists of three
components: 1) the implant, 2) deployment instrumentation, and
3) bone awl. The implant is comprised of 2-0 suture, two Nitinol
anchors with PEEK Inserts, and a PEEK Stabilizing Body. The
device is delivered through a specifically designed instrument.
The method of delivery allows for a shifting of the PEEK Body
which limits the amount of traction required to place the middle
phalanx over the device. The suture utilized in the device
serves multiple functions: 1) shifting of the PEEK Body and 2)
applying tension between the Nitinol anchors which in turn
stabilizes the proximal interphalangeal joint (PIPJ). |
| Indication for Use: | The ProxiFuse Hammer Toe Device is indicated for the fixation
of osteotomies and reconstruction of the lesser toes following
correction procedures for hammertoe, claw toe, and mallet toe.
Patients should be protected weight-bearing or heel-bearing
until fusion or healing has occurred. |
4
| Technological Characteristics: | The technological characteristics of the ProxiFuse Hammer Toe Device differ from predicates in the multicomponent design and use of polymer materials in combination with nitinol anchors to achieve stable fixation to enable fusion. Despite the differences in device shape, fundamental scientific technology, materials and method of delivery, standard test methods exist to demonstrate equivalent performance with respect to fixation (Pullout/Dis-assembly Testing) and stability (Static and Fatigue Bending Testing). By applying acceptable methods to evaluate effects on safety and effectiveness, substantial equivalence to the predicates is established. |
|---|---|
| Performance Testing Summary: | Bench testing was performed to assure substantial equivalence to a predicate device and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. No clinical data were needed to support the safety and effectiveness of the subject device. |
| Bench testing consisted of the following: USP Suture TestingPullout/Dis-assembly TestingStatic Bending TestingFatigue Bending TestingBench and Cadaver Testing | |
| Conclusion: | The ProxiFuse Hammer Toe Device is substantially equivalent to the named predicates based on technological comparison, indications for use, and laboratory and other safety testing. It is concluded that there are no new questions of safety and effectiveness. |