MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000

K011912 · Axya Medical, Inc. · MBI · Aug 31, 2001 · Orthopedic

Device Facts

• Record ID: K011912
• Device Name: MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
• Applicant: Axya Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Aug 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic monofilament non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 5mm anchor may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.

Device Story

The Axya Model 2000 AxyaLoop is a corkscrew-style, self-tapping bone anchor system used for soft tissue fixation in shoulder surgery. The system includes the bone anchor, pre-threaded with USP size 2 polypropylene monofilament suture, a bone punch, and a delivery/extraction tool. Designed for both open and arthroscopic procedures, the anchor is inserted into bone to secure sutures for rotator cuff or Bankart lesion repairs. The device functions as a mechanical fastener; it is operated by surgeons in an OR setting. The anchor provides a secure attachment point for sutures, facilitating tissue-to-bone reattachment to promote healing of shoulder injuries.

Clinical Evidence

Bench testing only. In vitro studies were conducted to evaluate anchor pull-out strength in accordance with the FDA Guidance Document for Testing Bone Anchor Devices (April 20, 1996). Results demonstrated that the pull-out force of the Axya Model 2000 was equivalent to the predicate device, with both exhibiting anchor pull-out as the predominant failure mode.

Technological Characteristics

Corkscrew-style self-tapping bone anchor; available in 3mm and 5mm diameters. Fabricated from materials with established history in medical applications. Pre-threaded with USP size 2 polypropylene monofilament suture. System includes manual surgical instruments (bone punch, delivery/extraction tool). Sterilized via standard industry processes.

Indications for Use

Indicated for securing synthetic monofilament non-absorbable suture to bone for shoulder injury repair, including rotator cuff repair (5mm anchor) and Bankart lesion repair (3mm anchor) in patients requiring shoulder stabilization.

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

• Mitek Fastin RC Suture Anchor (K983818)

Submission Summary (Full Text)

{0}------------------------------------------------

### SUMMARY OF SAFETY AND EFFECTIVENESS

#### General Company Information

Name: Axya Medical, Inc.

Address: 100 Cummings Center Suite 444C Beverly, MA 01915

| Telephone: | (978) 232 - 9997 |
|------------|------------------|
| Fax: | (978) 232 - 9998 |

## General Device Information

| Product Name: | Model 2000 AxyaLoop™ Self-Tapping Bone Anchor |
|-----------------|-------------------------------------------------------------------------------|
| Classification: | "Non-degradable soft tissue fixation fastener", Product code: MBI<br>Class II |

#### Predicate Device

Mitek. Fastin ® RC Suture Anchor [501(k) Number K983818]

#### Description

The device described in this submission is designed with a corkscrew style thread and will be made available initially in two sizes (diameters) specifically for use in shoulder repairs. (i.e. rotator cuff repairs). The Axya Self-Tapping Bone Anchor will be made available as a system together with a bone punch and a delivery/extraction tool. These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 2000 AxyaLoop Self-Tapping Bone Anchor is prethreaded with size 2 USP polypropylene monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers.

The Model 2000 Self-Tapping Bone Anchor is designed to be used in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

{1}------------------------------------------------

#### Indications

The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing synthetic monofilament non-absorbable suture to bone. This device is intended for use in repair of shoulder injuries. The 5mm anchor may typically be used to repair rotator cuff injuries. The 3 mm anchor may typically be used to repair recurrent dislocation of the shoulder where the anchor is placed through the metaphyseal cortex such as in the case of a Bankart lesion repair procedure.

### Substantial Equivalence

This submission supports the position that the Axya Model 2000 AxyaLoop Self-Tapping Bone Anchor is substantially equivalent to previously cleared devices, including the Mitek Fastin ® Suture Anchor [501(k) Number K983818].

The 510(k) Notice contains summaries of in vitro studies which were conducted to evaluate the anchor pull-out strength as specified in the FDA Guidance Document for Testing Bone Anchor Devices (dated April 20, 1996).

The data presented demonstrate that the anchor pull-out force of the Axya Model 2000 AxyaLoop Self-Tapping Bone Anchor was equivalent to that of the predicate device of similar corkscrew geometry (Mitek Fastin RC). The failure mode observed for the both anchors was predominately anchor pull-out.

The single-patient-use components of the bone anchor system are provided sterile. The suture material and bone anchors are sterilized by a process equivalent to the process used by the original suture manufacturer.

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed bone anchor devices have been used for the same clinical applications as the Axya Model 2000 AxyaLoop Self-Tapping Bone Anchor. The materials from which the Axya device is fabricated have an established history of use in medical applications, and devices produced by Axya have been tested in accordance with applicable FDA guidelines.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2001

Mr. Howard L. Schrayer Axya Medical, Incorporated 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re : K011912 Model 2000 AxyaLoop™ Self-Tappinq Trade/Device Name: Bone Anchor Regulation Number: 888.3030 and 888.3040 Requlatory Class: II Product Code: MBI and HWC Dated: June 18, 2001 Received: June 19, 2001

Dear Mr. Schrayer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements

{3}------------------------------------------------

Page 2 - Mr. Schrayer

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Mula M Mulkerso

lia M. Witten, Ph.D., M.D. Director, Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Kol 1912 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Axya, Model 2000 AxyaLoop™ Self-Tapping Bone Anchor

Indications For Use:

The Axya Model 2000 AxyaLoop™ Self-Tapping Bone Anchor is indicated for securing The raya monofilament non-absorbable suture to bone. This device is intended for use in bynthout monomainonies. The 5mm anchor may typically be used to repair rotator cuff ropair of onourael financhor may typically be used to repair recurrent dislocation of the injuries: "The o min anchor inaly typedia wetaphyseal cortex such as in the case of a Bankart lesion repair procedure.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of General, Restorative and Neurological Devices

| 510(k) Number | K011912 |
|---------------|---------|
|---------------|---------|

Use __________ OR Over-The-Counter Use __________Prescription U: (Per 21 CFR 801.109)

(Optional Format 1-2-96)