K Number
K083607
Device Name
APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
Date Cleared
2009-03-04

(89 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AperFix® Tibial 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.
Device Description
The Cayenne Medical AperFix® Tibial Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a screw and a twopart screw sheath. AperFix Tibial Implants are available in diameters of 8, 9, 10 and 11 mm with a standard length of 30 mm. Each device is intended for single use and is provided with a sterile inserter.
More Information

Not Found

Not Found

No
The summary describes a mechanical implant and inserter for ligament reconstruction, with no mention of software, algorithms, or any AI/ML related terms or functionalities.

Yes
The device is described as an internal fixation device used in reconstruction procedures for ligaments, which directly addresses a medical condition (ligament damage) to improve patient health and function.

No

Explanation: The device is described as an "internal fixation device intended to provide tendon to bone fixation" for reconstruction procedures, which are surgical treatments, not diagnostic processes.

No

The device description explicitly states it is a "non-absorbable internal fixation device" including a screw and screw sheath, which are physical hardware components.

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, such as blood, urine, or tissue, to provide information about a person's health.
  • Device Description: The provided description clearly states that the AperFix® Tibial Implant is a "non-absorbable internal fixation device intended to provide tendon to bone fixation." It is a physical implant used within the body during surgical procedures.
  • Intended Use: The intended use is for "tenodesis procedures with soft tissue grafts" during ligament reconstruction. This is a surgical procedure performed on the patient's body, not a test performed on a sample outside the body.

The device is a surgical implant, not a diagnostic test performed on a sample.

N/A

Intended Use / Indications for Use

The AperFix® Tibial 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

HWC

Device Description

The Cayenne Medical AperFix® Tibial Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a screw and a twopart screw sheath. AperFix Tibial Implants are available in diameters of 8, 9, 10 and 11 mm with a standard length of 30 mm. Each device is intended for single use and is provided with a sterile inserter.

The AperFix Tibial Implant with Inserter will be supplied sterile. Sterilization is accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy.

Mechanical testing was performed on the AperFix Tibial Implant. It was shown that pull-out strength is significantly higher than that of a predicate device.

Mentions image processing

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Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Mechanical testing was performed on the AperFix Tibial Implant. It was shown that pull-out strength is significantly higher than that of a predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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

K083607

510(k) Summary

FEB - 5 2009

Cayenne Medical, Inc. AperFix Tibial Implant with Inserter

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone (480) 520-3661 FAX (480) 520-3670

Official Contact:

Kereshmeh Shahriari

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

INTENDED USE

The AperFix® Tibial 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.

Revised Page 17 of 220

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DEVICE DESCRIPTION

The Cayenne Medical AperFix® Tibial Implant with Inserter is a non-absorbable internal fixation device intended to provide tendon to bone fixation in arthroscopic or open procedures during Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL), Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), and Medial Patellofemoral Ligament (MPFL) reconstruction. It includes a screw and a twopart screw sheath. AperFix Tibial Implants are available in diameters of 8, 9, 10 and 11 mm with a standard length of 30 mm. Each device is intended for single use and is provided with a sterile inserter.

The AperFix Tibial Implant with Inserter will be supplied sterile. Sterilization is accomplished by means of Co60 gamma irradiation at a dose of 25-40 kGy.

Mechanical testing was performed on the AperFix Tibial Implant. It was shown that pull-out strength is significantly higher than that of a predicate device.

EQUIVALENCE TO MARKETED PRODUCT

Cavenne 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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Public Health Service

Cayenne Medical, Inc. % Kereshmeh Shahriari 16597 N. 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re: K083607

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: II Product Code: HWC Dated: December 3, 2008 Received: December 5, 2008

Dear Kereshmeh Shahriari:

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.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3

Page 2 - Kereshmeh Shahriari

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number (if known): K083607

Device Name: AperFix® Tibial Implant with Inserter

Indications for Use:

The AperFix Tibial 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. Comment (

| Prescription Use

(Part 21 CFR 801 Subpart D)X
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)_________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices

510(k) Number1083.607
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