AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

K041698 · Axya Medical, Inc. · MAI · Oct 5, 2004 · Orthopedic

Device Facts

• Record ID: K041698
• Device Name: AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
• Applicant: Axya Medical, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Oct 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Utnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

Device Story

Bio-absorbable bone anchor system; corkscrew thread design; 5.0 mm nominal diameter. Used in open or arthroscopic surgical procedures for soft tissue-to-bone attachment. System includes anchor, thread tap, and placement tool (driver). Pre-threaded with USP polypropylene, nylon, braided polyester, or braided polyethylene sutures. Operated by surgeons in clinical settings. Anchor provides mechanical fixation of suture to bone; facilitates tissue repair/reconstruction. Benefits include secure soft tissue fixation during orthopedic and urological procedures.

Clinical Evidence

Bench testing only. In vitro studies conducted to evaluate anchor pull-out strength per FDA Guidance Document for Testing Bone Anchor Devices (April 20, 1996). Results showed pull-out force compared favorably with predicate devices of similar geometry.

Technological Characteristics

Bio-absorbable bone anchor with corkscrew thread geometry. 5.0 mm nominal diameter. System includes manual surgical instruments (tap, driver). Sterile, single-patient-use. Materials have established history in medical applications.

Indications for Use

Indicated for securing suture to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvic procedures (including female urinary incontinence).

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Arthrex Inc. Bio-Absorbable Corkscrew Suture Anchor Model AR-1920B (K003227)
• Mitek Worldwide Biofastin RC Threaded Suture Anchor (K021883)

Submission Summary (Full Text)

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K041698 pgeffs

# OCT 5 - 2004 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

### General Company Information

| Name: | Axya Medical, Inc. |
|----------|-------------------------------|
| Contact: | Howard Schrayer |
| | Regulatory Affairs Consultant |
| Address: | 100 Cummings Center |
| | Suite 444C |
| | Beverly, MA 01915 |

- Telephone: (978) 232 - 9997 Fax: (978) 232 - 9998
- Date Prepared June 19, 2004

## General Device Information

| Product Name: | Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor |
|-----------------|-----------------------------------------------------------------------------|
| Classification: | "Biodegradable soft tissue fixation fastener"<br>Product code: MAI Class II |

## Predicate Devices

Arthrex Inc. Bio-Absorbable Corkscrew Suture Anchor Model AR-1920B [501(k) Number K003227]

Mitek Worldwide Biofastin RC Threaded Suture Anchor [510(k) Number K021883]

## Description

The device described in this submission is designed with a corkscrew style thread and will be made available initially in a 5.0 mm nominal diameters, for use in a range of soft tissue to bone attachment procedures. The Axya Bone Anchor will be made available as a system together with a thread tap and a placement tool (driver). These accessories are the same types of instruments included in procedure sets for currently marketed bone anchor systems. Axva Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 5000 Bio-Albsorbable Bone Anchor is prethreaded with USP polypropylene monofilament, USP nylon, JJSP braided polyester and USP braided polyethylene suture materials.

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pe, 93

The Model 5000 Bio-Absorbable Bone Anchor is designed for use in both standard open surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

# Intended Use (Indications)

The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Utnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

#### Substantial Equivalence

This submission supports the position that the Axya Model 5000 Bio-Absorbable Bone Anchor is substantially equivalent to a number of previously cleared devices, including the the Arthrex lnc. Bio-absorbable Corkscrew Model AR-1920B Suture Anchor [501(k) Number K003227] and the Mitek Worldwide Biofastin RC Threaded Suture Anchor [510(k) K021883],

The 510(k) Notice contains summaries of in vitro studies that 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 5000 AxyaLoop Bio-Absorbable Bone Anchor compared favorably with the predicate device of similar corkscrew geometry. The failure mode observed for the Axya anchor was predominately the same as that of the predicate anchor.

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.

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# Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar legally marketed have been used for the same clinical applications as the Axya Model 5000 Bio-Absorbable 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 5 - 2004

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

K041698 Re:

KU41096
Trade/Device Name: Axya, Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI Dated: June 19, 2004 Received: July 7, 2004

Dear Mr. Schrayer:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for abound to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of they 2011-12-11 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 I ou may, alors, arovisions of the Act include requirements for annual registration, listing of general voltable profice, 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 may or days 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) I mis letter will and will your e 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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,

Sincerely yours,

O Mark N Mllham

Celia M. Witten, PhD, MD Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K041698

Device Name: Axya, Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor

Indications For Use:

The Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing suture to bone. This device is intended for use in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair. Hallux Valgus and Midfoot reconstruction

Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair. Iliotibial band tenodesis

Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction

Pelvis: Bladder neck suspension for urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency in females

**Prescription Use**
(Part 21 CFR 801 Subpart D)

AND/OR

**Over-The-Counter Use**
**(21 CFR 807 Subpart C)**
Ne

(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 | K041698 |