(69 days)
Not Found
Not Found
No
The summary describes a mechanical implant and inserter for ACL reconstruction, with no mention of AI or ML in its function or description.
Yes
The device is used to provide tendon to bone fixation during ACL reconstruction procedures, which is a therapeutic intervention.
No
The device is described as an implant and an inserter used for tendon to bone fixation during ACL reconstruction, which are therapeutic and surgical tools, not diagnostic ones.
No
The device description clearly outlines physical components (screw, screw sheath, inserter) made of a biocompatible polymer, 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 "tendon to bone fixation during arthroscopic or open ACL reconstruction procedures." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is an implant designed to be placed within the tibial tunnel to anchor a tendon. It is made of a biocompatible polymer and is used mechanically to secure tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The AperFix™ Tibial Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.
Product codes
HWC
Device Description
The AperFix Tibial Implant is a device that provides soft tissue compression within the prepared tibial tunnel to anchor the tendon. It includes a screw and a two-part screw sheath. AperFix Tibial Implants are available in diameters of 9, 10 and 11 mm with a standard length of 30 mm. Each AperFix Tibial Implant is supplied with the implant screw pre-loaded on a disposable inserter. The role of the inserter is to assist in implant placement within the tibial tunnel.
The AperFix Tibial Implant screw and sheath are manufactured from PEEK-OPTIMA** LT (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibial tunnel
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
510(k) Summary
AperFix™ Tibial Implant with Inserter
K063.70 P.g. 192
510(k) Summary
DEC 1 4 2006
Cayenne Medical, Inc. AperFix™ Tibial Implant with Inserter
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Cayenne Medical, Inc.
8541 E Anderson Drive, Suite 100
Scottsdale, AZ 85255
Telephone (480) 520-3661
Fax (480) 520-3670 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Derek Harper |
| Representative/Consultant: | Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA 92130
Telephone (858) 792-1235
Fax (858) 792-1236 |
| DEVICE NAME | |
| Classification Names: | Screw, fixation, bone |
| Trade/Proprietary Name: | AperFix™ Tibial Implant with Inserter |
| Common Name: | Bone screw |
DEVICE CLASSIFICATION
FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for screw, fixation, bone is HWC. These devices are reviewed by the Orthopedic Joint Devices Branch.
1
INTENDED USE
The AperFix™ Tibial Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.
DEVICE DESCRIPTION
The AperFix Tibial Implant is a device that provides soft tissue compression within the prepared tibial tunnel to anchor the tendon. It includes a screw and a two-part screw sheath. AperFix Tibial Implants are available in diameters of 9, 10 and 11 mm with a standard length of 30 mm. Each AperFix Tibial Implant is supplied with the implant screw pre-loaded on a disposable inserter. The role of the inserter is to assist in implant placement within the tibial tunnel.
The AperFix Tibial Implant screw and sheath are manufactured from PEEK-OPTIMA** LT (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc.
EQUIVALENCE TO MARKETED PRODUCT
Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the AperFix Tibial Implant with Inserter is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
2
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 three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2006
PaxMed International, LLC % Mr. Floyd G. Larson 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K063070
Trade/Device Name: AperFix™ Tibial Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 5 2006 Received: October 6, 2006
Dear Mr. Larson:
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 such 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); 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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Page 2 – Mr. Floyd G. Larson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saubara Buchup
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
063.70 510(k) Number (if known):
Device Name: AperFix™ Tibial Implant with Inserter
Indications for Use:
The AperFix™ Tibial Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NO AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| 510(k) Number | K063070 |