(168 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for use in ligament and tendon repairs, which are therapeutic interventions.
No
The device is described as a K-wire intended for use in ligament and tendon repairs, functioning as an implant. Its described use and performance studies (strength, stiffness, cyclic testing) focus on its mechanical properties and suitability for surgical implantation, not on diagnosing medical conditions.
No
The device description explicitly states it is manufactured from PEEK and is a physical implant (K-Wire). The performance studies also focus on the mechanical properties of the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "use with suture in metatarsal ligament and tendon repairs." This describes a surgical implant used directly on a patient's body for structural support and repair.
- Device Description: The description details a physical implant made of PEEK, designed to be inserted into tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition. IVDs are used for diagnostic purposes, not for direct therapeutic or structural support within the body.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsal
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)
Nonclinical Testing:
All necessary testing has been performed for the Threaded PEEK K-Wire to assure substantial equivalence to the predicate and 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:
- . Simulated use Testing
- . Ultimate Strength Testing
- Initial Stiffness Testing .
- . Suture Strength Testing
- . Cyclic Testing
The results of this testing demonstrate that the Threaded PEEK K-Wire performs as intended and demonstrate that the Threaded PEEK K-Wire is substantially equivalent to its predicates.
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.
K101679, K082810, K071177, K063479, K061863, K051219
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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K133235 Page 1 of 2
510(k) Summary
| Device Trade Name: | Threaded PEEK K-Wire |
|---|---|
| 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: | April 4, 2014 |
| Common Name: | Threaded Fixation Pin |
| Classification: | 21 CFR 888.3040 Smooth or threaded metallic bone |
| fixation fastener | |
| Class: | II |
| Product Code: | MBI |
Indications for Use:
The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
Device Description:
Threaded K-Wire is manufactured from PEEK and is 1.6 mm in diameter over its entire length. Both ends of the K-Wire are threaded, providing for two implants per device. The diameter of the pin allows it to function well with standard K-Wire drivers and the device is meant to be trimmed to length once in place.
1
Predicate Devices:
The Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (K101679, K082810, K071177, K063479, K061863, K051219) with respect to its indications for use, principles of operation, materials and design.
Technological Characteristics Comparison:
The Threaded PEEK K-wire is similar to the Arthrex PushLock with regards to principles of operation, materials and design with both the subject and predicate devices being manufactured from PEEK, cylindrical in shape with threads or ribs and acting to compress suture against a bone tunnel wall. There are no substantial differences in technological characteristics between the devices and as such the Threaded PEEK K-Wire introduces no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the Threaded PEEK K-Wire to assure substantial equivalence to the predicate and 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:
- . Simulated use Testing
- . Ultimate Strength Testing
- Initial Stiffness Testing .
- . Suture Strength Testing
- . Cyclic Testing
The results of this testing demonstrate that the Threaded PEEK K-Wire performs as intended and demonstrate that the Threaded PEEK K-Wire is substantially equivalent to its predicates.
Conclusion:
The Threaded PEEK K-Wire met all specified criteria performing as intended and did not raise any new issues of safety or effectiveness. The Threaded PEEK K-Wire is substantially equivalent to the Arthrex PushLock predicate with regards to indications for use, as the Threaded PEEK K-Wire indications for use represent a subset of the Arthrex PushLock indications for use. The fundamental scientific technology of the Threaded PEEK K-Wire is the same as described in the Arthrex PushLock predicates. Therefore, the Threaded PEEK K-Wire is substantially equivalent to the Arthrex, Inc. PushLock (K101679, K082810, K071177, K063479, K061863, K051219).
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
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
April 7, 2014
MTP Solutions LLC Mr. Robert Hoy Director of Technical & Clinical Research 124 South 600 West, Suite 100 Logan, Utah 84321
Re: K133235
Trade/Device Name: Threaded PEEK K-Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 28, 2014 Received: March 4, 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/Resourcesfor You/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/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
Threaded PEEK K-Wire - Traditional 510(k)
Indications for Use
510(k) Number (if known): K133235
Device Name: Threaded PEEK K-Wire
Indications for Use:
The Threaded PEEK K-Wire is intended for use with suture in metatarsal ligament and tendon repairs.
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 1
Elizabet同級rank -S
Division of Orthopedic Devices