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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AperFix® AM Femoral Implant with Inserter, based on the provided 510(k) summary:

The provided document is a 510(k) Summary for a device modification, specifically a line extension (a shortened version of an existing implant). The primary focus of this type of submission is to demonstrate substantial equivalence to a predicate device, rather than proving initial safety and efficacy for a novel device through extensive clinical trials. Therefore, the "acceptance criteria" and "study" described herein relate to demonstrating equivalence for the modification, not necessarily proving full clinical utility from scratch.

Here is the requested information:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pull-out strength comparable to predicate device	"It was shown that pull-out strength is comparable to the predicate device."
Product dimensional analysis met component and product specifications	"Product dimensional analysis met the components and product specifications."

Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Mechanical testing was performed" and "Dimensional analysis was performed," but does not provide specific sample quantities for these tests.
- Data Provenance: The document does not specify country of origin for the data or whether the tests were retrospective or prospective. Given the nature of mechanical and dimensional testing, these are typically prospective laboratory tests conducted by the manufacturer.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth for mechanical and dimensional testing is established by technical specifications, engineering standards, and direct measurement, not by human expert interpretation.
Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical or image-based studies. Mechanical and dimensional tests have objective pass/fail criteria based on predefined specifications.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data (e.g., images) and the AI's impact on their performance is being evaluated. This submission is for an orthopedic implant.
If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
- Not applicable. This is an orthopedic implant, not an algorithm or software device. Performance is based on mechanical properties and dimensions, not algorithmic output.
The Type of Ground Truth Used
- Engineering Specifications and Standards: For mechanical testing (pull-out strength), the ground truth would be defined by established engineering principles for fixation strength in bone, relevant ASTM standards (if applicable), and the performance characteristics of the predicate device. For dimensional analysis, the ground truth is the engineering design specifications and drawings for the implant components.
The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of mechanical and dimensional testing for a physical implant. The device's design is validated against specifications, not trained on data.
How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no training set, there's no ground truth for it. The "ground truth" for the device's design and performance validation (as mentioned in point 7) is established through engineering design, material science principles, and comparison to the predicate device.

Summary

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Page 1/2

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 +1 (480) 502-3661 Fax +1 (480) 502-3670

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

Page 2/2

510(k) Summary

AperFix® AM Femoral Implant with Inserter

DEVICE DESCRIPTION AND COMPARISON WITH PREDICATE DEVICE

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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Page 2 - Ms. Kereshmeh Shahriari

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 (800) 638-2041 or (301) 796-7100 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:

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

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

510(k) Number K122463

Page 14 of 95

Regulation Number and Section

§ 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.