(133 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would involve AI/ML.
No
The device is an implantable medical device used for fixation of osteotomies and reconstruction of lesser toes, which falls under the category of surgical devices or orthopedic implants, not a general therapeutic device that delivers therapy in the traditional sense like drug delivery or radiation therapy.
No
The PEEK Fusion Implant is designed for the fixation of osteotomies and reconstruction of lesser toes. Its purpose is to physically join bone fragments, not to identify or determine the presence of a disease or condition.
No
The device description explicitly states it is manufactured from PEEK and is composed of two threaded components, indicating a physical implant, not software.
Based on the provided information, 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: The PEEK Fusion Implant is a physical implant designed to be surgically placed within the body to fix bones. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for the fixation and reconstruction of bones in the lesser toes, which is a surgical procedure, not a diagnostic test.
Therefore, the PEEK Fusion Implant falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 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 PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another 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)
Pre-clinical testing has been performed for the PEEK Fusion Implant 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. Clinical data were not needed to support the safety and effectiveness of the subject device.
The device design was qualified through the following tests:
- Tensile Strength Testing
- Bending Strength Testing
- Torsion Strength Testing
- Shear Strength Testing
- Screw Insertion Testing
- Driver Torque to Failure Testing
- Association & Disassociation Testing
- Four-point Bending Fatigue Testing
- Tensile Load after Fatigue Testing
The results of this testing demonstrate that the PEEK Fusion Implant performs as intended and has greater bending, torsion, shear and post-fatigue tensile strength and equivalent time zero tensile strength and fatigue performance when compared to the predicate. In addition, the driver/implant interface torque failure loads exceeded the torque required to insert the implants and no disassociation of the implants was observed during fatigue testing.
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.
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K133515 Page 1 of 2
510(k) Summary
| Device Trade Name: | 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: | March 28, 2014 |
| Common Name: | Screw, Fixation, Bone |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | HWC |
Indications for Use:
The 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 PEEK Fusion Implant is manufactured from polyetheretone (PEEK) and is composed of two threaded components, each designed to engage either side of an osteotomy or reconstruction site. Once in position, the components mate with one another allowing for reduction and fixation of the bone fragments.
Predicate Devices:
The PEEK Fusion Implant is substantially equivalent to the Arthrex Bio-Pin (marketed as the Trim-It Pin) [K050259], the OsteoMed ExtremiFuse [K130412] and the Nextremity FlexFusion Implant (marketed as the Nextra) [K110445] with respect to its indications for use, geometry, dimensions, function and performance.
1
Technological Characteristics Comparison:
The PEEK Fusion Implant and its predicate devices are similar in size and all generally cylindrical in shape. In addition, all devices are designed to be deployed across osteotomy and reconstruction sites with the purpose of fixing bone fragments. The PEEK Fusion Implant is manufactured from polyetheretone (PEEK) while the Arthrex Bio-Pin predicate is composed of poly (L-lactide); the OsteoMed ExtremiFuse predicate is made from titanium alloy and the Nextremity FlexFusion predicate from stainless steel. All four materials are present in many FDA cleared permanent implants and have a long history of biocompatibility. The biocompatibility of the candidate device material is further substantiated by the data available in an FDA Master File. In addition, mechanical test results demonstrate that the difference in material increases the construct strength as determined in side-by-side testing vs. a predicate device. Therefore, this difference in technology introduces no new issues of safety or effectiveness.
Nonclinical Testing:
Pre-clinical testing has been performed for the PEEK Fusion Implant 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. Clinical data were not needed to support the safety and effectiveness of the subject device.
The device design was qualified through the following tests:
- . Tensile Strength Testing
- Bending Strength Testing .
- . Torsion Strength Testing
- Shear Strength Testing .
- . Screw Insertion Testing
- . Driver Torque to Failure Testing
- Association & Disassociation Testing .
- Four-point Bending Fatigue Testing .
- Tensile Load after Fatigue Testing .
The results of this testing demonstrate that the PEEK Fusion Implant performs as intended and has greater bending, torsion, shear and post-fatigue tensile strength and equivalent time zero tensile strength and fatigue performance when compared to the predicate. In addition, the driver/implant interface torque failure loads exceeded the torque required to insert the implants and no disassociation of the implants was observed during fatigue testing.
Conclusion:
The 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 PEEK Fusion Implant are similar to those described in the predicate devices. The PEEK Fusion Implant has been determined by MTP Solutions to be substantially equivalent to the Arthrex Bio-Pin (marketed as the Trim-It Pin) [K050259], the OsteoMed ExtremiFuse [K130412] and the Nextremity FlexFusion Implant (marketed as the Nextra) [K110445].
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
MTP Solutions LLC Mr. Robert Hoy Director of Technical & Clinical Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K133515
Trade/Device Name: 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: March 4, 2014 Received: March 5, 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 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
3
Page 2 - Mr. Robert Hoy
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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.
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
4. Indications for Use
510(k) Number (if known): __K133515
Device Name: PEEK Fusion Implant
Indications for Use:
The 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.
V Prescription Use (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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133515