(23 days)
KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
Not Found
No
The summary describes a mechanical implant and inserter for surgical procedures, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
This device is an implantable fixation device used in surgical procedures (tenodesis) to reconstruct ligaments; it does not treat or cure a disease or condition in a therapeutic sense.
No.
The device is a surgical implant intended for use in tenodesis procedures for ligament reconstruction, not for diagnosis.
No
The device description clearly states it is a "Femoral Implant with Inserter" and describes physical components like a "two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle." This indicates a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The KFx APPIANFx PEEK Femoral Implant with Inserter is a physical implant designed to be surgically placed within the body to fix soft tissue grafts during ligament reconstruction. It is a surgical device, not a device that analyzes samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure (tenodesis) involving the implantation of a device within the body.
The information provided describes a surgical implant and its delivery system, which falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Product codes
MBI
Device Description
KFx APPIANFx PEEK Femoral Implant with Inserter consists of a two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle. Technologically it is similar in design, materials and mode of operation to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
APPIANFx PEEK Femoral Implants are available in 8 and 9 mm diameters and are 27 mm long pre-deployment. Each device is intended for single use and is pre-loaded on a sterile inserter. The device may be used in both arthroscopic and open procedures.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test data, which includes cycle testing and pullout strength, indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
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
MAY 2 0 2010
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
KIDI JEZ (1/2)
APPLICANT INFORMATION
| A. | Company Name: | KFx Medical, Corporation |
|---|---|---|
| B. | Company Address: | 5845 Avenida Encinas |
| Suite 128 | ||
| Carlsbad, CA 92008 | ||
| C. | Company Phone: | (760) 444-8844 |
| D. | Company Facsimile: | (760) 602-9252 |
| E. | Contact Person: | Gayle Hirota |
| OA/RA |
DEVICE IDENTIFICATION
| A. | Trade Name: | KFx APPIANFx PEEK Femoral Implant with
Inserter |
|----|-----------------------|----------------------------------------------------|
| B. | Common Name: | Bone Anchor |
| C. | Classification Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| D. | Product Code: | MBI |
| E. | Device Panel: | Orthopedic |
| F. | Device Class: | Class II |
| | DATE SUMMARY PREPARED | April 25, 2010 |
IDENTIFICATION OF MODIFIED DEVICE
The KFx APPIANFx PEEK Femoral Implant with Inserter is substantially equivalent to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
DEVICE DESCRIPTION
KFx APPIANFx PEEK Femoral Implant with Inserter consists of a two body anchor fixation device comprised of a body with deployable arms and a wedge and a disposable suture loop preloaded in a delivery (insertion) handle. Technologically it is similar in design, materials and mode of operation to the KFx PEEK Bone Anchor with Pre-Attached Sutures and Delivery Handle.
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APPIANFx PEEK Femoral Implants are available in 8 and 9 mm diameters and are 27 mm long pre-deployment. Each device is intended for single use and is pre-loaded on a sterile inserter. The device may be used in both arthroscopic and open procedures.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.
INTENDED USE
The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts, utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
BIOCOMPATIBILITY AND PERFORMANCE DATA
The materials used in the KFx APPIANFx PEEK Femoral Implant with Inserter are biocompatible and identical to the materials used in the predicate device. The same materials are used in a myriad of legally marketed orthopedic devices.
Non-clinical test data, which includes cycle testing and pullout strength, indicate that the device is safe and satisfies functional performance requirements when used as indicated and do not raise new issues of safety or effectiveness.
CONCLUSIONS DRAWN FROM STUDIES
The documentation provided demonstrates that the KFx APPIANFx PEEK Femoral Implant with Inserter is substantially equivalent to the currently marketed predicate device and is safe and effective when used as indicated.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The logo is simple, clean, and easily recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
KFx Medical Corporation % Ms. Gayle Hirota 5845 Avenida Encinas, Suite 128 Carlsbad, CA 92008
MAY 2 0 2010
Re: K101175
Trade/Device Name: KFx APPIANFx PEEK Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: April 25, 2010 Received: April 27, 2010
Dear Ms. Hirota:
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.
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
C. Fintan Bucchino
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 1.6 Indications for Use.
510(k) Number (if known): 《 | 0 | | 7-5
Device Name: KFx APPIANFx PEEK Femoral Implant with Inserter
Indications For Use: The KFx APPIANFx PEEK Femoral Implant with Inserter is intended for use in tenodesis procedures with soft tissue grafts. utilizing either arthroscopic or open techniques during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oxtin for mxm
(D)vision Sign Aco
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101175
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