APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W

K122463 · Cayenne Medical, Inc. · MBI · Oct 11, 2012 · Orthopedic

Device Facts

• Record ID: K122463
• Device Name: APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W
• Applicant: Cayenne Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AperFix® AM 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.

Device Story

AperFix AM Femoral Implant is a non-absorbable internal fixation device for anchoring tendon grafts within a femoral tunnel during ligament reconstruction; enables tissue ingrowth for permanent bony attachment. Device is a line extension (24 mm version) of the original 29 mm implant to accommodate anatomical variations. Operates via central screw advancement, causing lateral deflection of body wings to engage femoral tunnel walls. Used by surgeons in OR settings during arthroscopic or open procedures. Benefits include improved graft placement flexibility in patients with specific anatomical conditions or deformities. Mechanical pull-out strength is comparable to the predicate.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated pull-out strength comparable to the predicate device. Dimensional analysis confirmed the device met all product specifications.

Technological Characteristics

Non-absorbable metallic/polymeric bone fixation fastener. Features a central screw and lateral wings that deflect to engage the femoral tunnel wall. 24 mm length. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients undergoing tenodesis procedures with soft tissue grafts for ACL, PCL, MCL, LCL, or MPFL reconstruction via arthroscopic or open surgical techniques.

Regulatory Classification

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.

Predicate Devices

• Cayenne Medical AperFix® Femoral Implant with Inserter (K083612)

Submission Summary (Full Text)

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510(k) Summary

AperFix® AM Femoral Implant with Inserter

## 510(k) Summary

OCT 11 2012

Cayenne Medical, Inc. Special 510(k): Device Modification

AperFix® AM Femoral Implant with Inserter

## ADMINISTRATIVE INFORMATION

510(k) Number:

### Manufacturer Name:

## K122463

Cayenne Medical, Inc. 16597 N. 92nd St., Suite 101 Scottsdale, AZ 85260 Telephone [phone] Fax [phone]

Kereshmeh Shahriari

September 11, 2012

Official Contact:

510(k) Summary Preparation Date

Predicate Device

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Classification Name:

Product Code: Classification Panel: Reviewing Branch:

#### INTENDED USE

AperFix® AM Femoral Implant Fastener, Fixation, Nondegradable, Soft tissue Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040 Class II MBI Orthopedic Devices Orthopedic Joint Devices Branch

Cayenne Medical AperFix® Femoral Implant with Inserter, K083612

The AperFix® AM 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.

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K122463

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510(k) Summary

AperFix® AM Femoral Implant with Inserter

## DEVICE DESCRIPTION AND COMPARISON WITH PREDICATE DEVICE

The AperFix AM Femoral Implant with Inserter is a non-absorbable internal fixation device used in arthroscopic or open cruciate ligament reconstruction to anchor tendon grafts (such as the hamstring tendon) within a surgically created femoral tunnel to enable tissue ingrowth with the resultant formation of a permanent bony attachment.

Modifications to the device that are the subject of this submission are confined solely to limited to a line extension consisting of a 24 mm (shortened) version of the original 29 mm implant to enable greater flexibility in tendon graft placement within the femur when clinical conditions (i.e. anatomy and/or deformity) preclude use of the original 29 mm device.

The body wedge and wings of the modified 24 mm device differ from those of the original 29 mm device in that the wings are one piece (as opposed to using an assembly of a wedge, two arms, and two pins). In both the 24 mm and 29 mm versions of the AperFix device, the advancing head of the central screw causes lateral deflection of the body as the implant is secured in position. In the subject 24 mm device, the wings engage the wall of the femoral tunnel upon tightening the central screw. In the predicate 29 mm device the arms engage the wall of the femoral tunnel upon tightening the central screw and wedge.

## NON-CLINICAL TESTING

Non-clinical testing data was submitted, referenced, or relied upon to demonstrate substantial equivalence. Mechanical testing was performed on the AperFix AM Femoral Implant with Inserter. It was shown that pull-out strength is comparable to the predicate device. Dimensional analysis was performed on the AperFix AM Femoral Implant with Inserter. Product dimensional analysis met the components and product specifications.

## EQUIVALENCE TO MARKETED PRODUCT

The AperFix® AM Femoral Implant with Inserter has the following similarities to the unmodified predicate devices:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same polymeric materials,
- · incorporates equivalent metallic materials, and
- · is packaged using the same materials and processes.

In summary, the AperFix® AM Femoral Implant with Inserter described in this submission is, in our opinion, substantially equivalent to the predicate devices. The data included in this submission demonstrates substantial equivalence to the predicate device listed above. Any differences in the technological characteristics between the subject and predicate device does not raise new issues of safety or efficacy.

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Image /page/2/Picture/1 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 a stylized image of an eagle or bird with its wings spread, composed of three thick, curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cayenne Medical, Incorporated % Ms. Kereshmeh Shahriari Senior Director of Regulatory Affairs, Quality & Compliance 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260

OCT 11 2012

Re: K122463

Trade/Device Name: AperFix® AM Femoral Implant with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 10, 2012 Received: September 13, 2012

Dear Ms. 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. 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

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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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Erine Keith

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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Special 510(k): Device Modification

AperFix® AM Femoral Implant with Inserter

# Indications for Use

K122463 510(k) Number (if known):

AperFix® AM Femoral Implant with Inserter

Indications for Use:

Device Name:

The AperFix AM Femoral Implant 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Lount

01

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122463

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