AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM

K022207 · Axya Medical, Inc. · MBI · Oct 4, 2002 · Orthopedic

Device Facts

• Record ID: K022207
• Device Name: AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
• Applicant: Axya Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Oct 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below: Foot and Ankle 1 Hallux Valgus repairs 2 Medial or lateral instability repairs/reconstructions 3 Achilles tendon repairs/reconstructions 4 Midfoot reconstructions 5 Metatarsal ligament/tendon repairs/reconstructions Elbow wrist and Hand 1 Scapholunate ligament reconstructions 2 Ulnar and radial collateral ligament reconstructions 3 Lateral epicondylitis repair 4 Biceps tendon reattachment

Device Story

Titanium bone anchor with corkscrew thread; 2.0 mm diameter; prethreaded with 2/0 USP non-absorbable monofilament suture. System includes drill bit, delivery/extraction handle, and drill guide. Used in open or arthroscopic surgical procedures for soft tissue-to-bone fixation in extremities. Operated by surgeons. Anchor provides mechanical fixation; suture secures tissue. Benefits include stable reattachment of tendons/ligaments to bone to facilitate healing.

Clinical Evidence

Bench testing only. In vitro study conducted per FDA Guidance Document for Testing Bone Anchor Devices (April 20, 1996) to evaluate pull-out strength. Results showed pull-out force compared favorably to predicate device.

Technological Characteristics

Titanium bone anchor; 2.0 mm diameter; corkscrew thread design; prethreaded with 2/0 USP non-absorbable monofilament suture. System includes manual surgical instruments (drill bit, handle, guide). Sterile, single-patient-use.

Indications for Use

Indicated for securing soft tissue to bone in extremity repairs (foot, ankle, elbow, wrist, hand) using 2/0 synthetic non-absorbable suture. Applicable for hallux valgus, ligament/tendon reconstructions, and tendon reattachments.

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

• Axya Medical, Inc. Model 1000 AxyaLoop™ Suture Anchor (K003971)
• Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor (K000797)

Submission Summary (Full Text)

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OCT 0 4 2002

K022207
page 1 of 2

# SUMMARY OF SAFETY AND EFFECTIVENESS

# General Company Information

Axya Medical, Inc. Name:

- 100 Cummings Center Address: Suite 444C Beverly, MA 01915
- [phone] Telephone: (978) 232 - 9998 Fax:

#### General Device Information

| Product Name: | Model 3000 AxyaLoop™ Titanium Bone Anchor |
|-----------------|------------------------------------------------------------------------------|
| Classification: | "Non-degradable soft tissue fixation fastener", Product code: MB<br>Class II |

# Predicate Devices

Axya Medical, Inc. Model 1000 AxyaLoop™ Suture Anchor [501(k) Number K003971]

Orthopaedic Biosystems Mini Tac 2.0 mm Bone Anchor [510(k) Number K000797]

# Description

The device described in this submission is designed with a corkscrew style thread and is available in a 2.0 mm diameter specifically for use in ankle, foot, elbow, wrist and hand repairs and reconstructions. The Axya Bone Anchor is available as a system together with a drill bit, a delivery/extraction handle and a drill guide. 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 3000 Titanium Bone Anchor is prethreaded with size 2/0 USP non-absorbable monofilament suture material. The suture is a legally marketed material, manufactured by one of several contract suppliers. The Model 3000 Titanium Bone Anchor is intended for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

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# Indications

The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below:

# Foot and Ankle

- 1 Hallux Valgus repairs
- 2 Medial or lateral instability repairs/reconstructions
- 3 Achilles tendon repairs/reconstructions
- 4 Midfoot reconstructions
- 5 Metatarsal ligament/tendon repairs/reconstructions

# Elbow wrist and Hand

- 1 Scapholunate ligament reconstructions
- 2 Ulnar and radial collateral ligament reconstructions
- 3 Lateral epicondylitis repair
- 4 Biceps tendon reattachment

# Substantial Equivalence

This submission supports the position that the Axya Model 3000 Titanium Bone Anchor is substantially equivalent to a number of previously cleared devices, including those referenced above.

The 510(k) Notice contains summaries of an in vitro study that was 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 3000 AxyaLoop Titanium Bone Anchor compared favorably with the predicate device of similar diameter and corkscrew geometry (OBL 2.0 mm Mini Tac). The failure mode observed for the Axya anchor and the predicate anchor was the same (i.e. 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 anchors have been used for the same clinical applications as the Axya Model 3000 Titanium Bone Anchor. The materials from which the Axya device is fabricated have an established history of use in medical applications, and the devices produced by Axya have been tested in accordance with applicable FDA guidelines.

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#### 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 eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure.

#### Public Health Service

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

OCT 04 2002

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

Re: K022207

Trade/Device Name: Model 3000 AxyaLoop™ Titanium Bone Anchor System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: MBI, HWC, GAS Dated: July 3, 2002 Received: July 8, 2002

Dear Mr. Schrayer:

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. Howard L. Schrayer

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. 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 Part 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,
Q. Mark A. Milliman

Celia 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

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page 1 of 1

KorzioT 510(k) Number (if known):

Device Name: Axya, Model 3000 AxyaLoop™ Titanium Bone Anchor

Indications For Use:

The Axya Model 3000 AxyaLoop™ Titanium Bone Anchor System is indicated for securing soft tissue to bone with size 2/0 synthetic non-absorbable suture in repairs of the extremities such as those shown below:

#### Foot and Ankle

- 1 Hallux Valgus repairs
- 2 Medial or lateral instability repairs/reconstructions
- 3 Achilles tendon repairs/reconstructions
- 4 Midfoot reconstructions
- 5 Metatarsal ligament/tendon repairs/reconstructions

#### Elbow, Wrist and Hand

- 1 Scapholunate ligament reconstructions
- 2 Ulnar and radial collateral ligament reconstructions
- 3 Lateral epicondylitis repair
- 4 Biceps tendon reattachment

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number ***_***_K022207

Prescription Use ***_***_ OR Over-The-Counter Use ***_***_
(Per 21 CFR 801.109)

(Optional Format 1-2-96)