(27 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an implant for bone fixation and reconstruction, which aids in healing by providing structural support, rather than actively treating a disease or condition to restore health.
No
The device is described as an implant for fixation and reconstruction of lesser toes following correction procedures. Its function is to provide structural support and facilitate healing, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a physical implant made of PEEK, designed for surgical fixation of bones. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant made of PEEK, designed to be surgically inserted into the lesser toes to fix bone fragments after osteotomies or reconstructions. This is a physical implant used within the body, not a device used to test samples outside the body.
The description focuses on the mechanical properties and surgical application of the implant, which are characteristic of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The device design was evaluated using the following verification tests, which are the same tests performed on the predicate device to establish its substantial equivalence in submission K133515:
- Tensile Strength .
- . Bending Strength
- Torsional Strength .
- . Fatigue Testing
- Post-Fatigue Tensile Strength .
The results of this testing as summarized in the Design Control Activities Summary demonstrate that the One-Piece PEEK Fusion Implant met the pre-determined acceptance criteria for the verification activities. Therefore, the differences between the modified and predicate devices introduce no new issues of safety or effectiveness.
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.
Not Found
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
K140970 Page 1 of 2
510(k) Summary
| Device Trade Name: | One-Piece PEEK Fusion Implant |
|---|---|
| Manufacturer: | MTP Solutions LLC |
| 124 South 600 West, Suite 100 | |
| Logan, UT 84321 | |
| Contact: | Mr. Robert Hoy |
| Director of Technical & Clinical Research | |
| Phone: (614) 448-6358 | |
| Fax: (435) 213-4878 | |
| bob@venturemd.com | |
| Prepared by: | Musculoskeletal Clinical & Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Fax: (202) 552-5798 | |
| Date Prepared: | May 12, 2014 |
| Common Name: | Screw, Fixation, Bone |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | HWC |
Indications for Use:
The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
Device Description:
The One-Piece PEEK Fusion Implant is manufactured from polyetheretherketone (PEEK). It is threaded on one end and ridged on the other to engage either side of an osteotomy or reconstruction site. The One-Piece PEEK Fusion Implant is threaded into the proximal phalanx and then it is press fit into the middle phalanx, allowing for reduction and fixation of the bone fragments.
1
Predicate Devices:
The One-Piece PEEK Fusion Implant is substantially equivalent to the MTP Solutions LLC PEEK Fusion Implant (K133515) and Arthrex Bio-Pin device (K050259) with respect to its indications for use, materials, dimensions, function and performance.
Technological Characteristics Comparison:
The One-Piece PEEK Fusion Implant and its predicate device are available in similar sizes and dimensions. In addition, both devices are designed to be deployed across osteotomy and reconstruction sites with the purpose of fixing bone fragments. Both the One-Piece PEEK Fusion Implant and PEEK Fusion Implant (K133515) are manufactured from polyetheretherketone (PEEK). The biocompatibility of the candidate device material and predicate device is further substantiated by the data available in MAF-1922.
Nonclinical Testing:
The device design was evaluated using the following verification tests, which are the same tests performed on the predicate device to establish its substantial equivalence in submission K133515:
- Tensile Strength .
- . Bending Strength
- Torsional Strength .
- . Fatigue Testing
- Post-Fatigue Tensile Strength .
The results of this testing as summarized in the Design Control Activities Summary demonstrate that the One-Piece PEEK Fusion Implant met the pre-determined acceptance criteria for the verification activities. Therefore, the differences between the modified and predicate devices introduce no new issues of safety or effectiveness.
Conclusion:
The One-Piece PEEK Fusion Implant met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Indications/Intended Use and the fundamental scientific technology of the One-Piece PEEK Fusion Implant are identical to those described in the predicate device. The One-Piece PEEK Fusion Implant has been determined by MTP Solutions to be substantially equivalent to the PEEK Fusion Implant (K133515) and Arthrex Bio-Pin device (K050259).
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2014
MTP Solutions LLC Mr. Robert Hoy Director of Technical & Clinical Research 124 South 600 West. Suite 100 Logan, Utah 84321
Re: K140970
Trade/Device Name: One-Piece PEEK Fusion Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 15, 2014 Received: April 16, 2014
Dear Mr. Hoy:
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 10 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): K140970 (pg 1/1)
Device Name: One-Piece PEEK Fusion Implant
Indications for Use:
The One-Piece PEEK Fusion Implant is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mailet toe.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of
Elizabeth | ank -S
Division of Orthopedic Devices