AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

K051250 · Axya Medical, Inc. · MAI · Jun 9, 2005 · Orthopedic

Device Facts

• Record ID: K051250
• Device Name: AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
• Applicant: Axya Medical, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Jun 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Axya Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing soft tissue to bone in the following applications: Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular joint repair, 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

Device Story

Bio-absorbable bone anchor system; 6.5 mm diameter corkscrew thread design; used for soft tissue-to-bone attachment in orthopedic and pelvic surgeries. System includes anchor, thread tap, and placement tool (driver). Operated by surgeons in open or arthroscopic procedures. Anchor pre-threaded with various suture materials (polypropylene, nylon, polyester, polyethylene). Provides mechanical fixation of soft tissue to bone; facilitates healing; bio-absorbable material eliminates need for secondary removal. Clinical benefit: secure tissue reattachment during reconstructive surgery.

Clinical Evidence

Bench testing only. In vitro studies evaluated anchor pull-out force in accordance with FDA Guidance Document for Testing Bone Anchor Devices (April 20, 1996). Results showed pull-out force compared favorably with predicate devices.

Technological Characteristics

Bio-absorbable bone anchor; 6.5 mm diameter corkscrew thread; manual surgical instrumentation (tap and driver). Materials have established history of use in orthopedic implants. Provided sterile for single-patient use.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvic procedures (e.g., ligament/tendon repair, bladder neck suspension). Applicable to adult patients requiring surgical soft tissue stabilization.

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

• Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor (K041698)
• 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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K051250

## JUN 9 - 2005

## 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 |

- 100 Cummings Center Address: Suite 444C Beverly, MA 01915
- [phone] Telephone: (978) 232 - 9998 Fax:
- May 13, 2005 Date Prepared

### General Device Information

| Product Name: | Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor |
|-----------------|-----------------------------------------------------------------------------|
| Classification: | "Biodegradable soft tissue fixation fastener"<br>Product code: MAI Class II |

#### Predicate Devices

Axya Model 5000 AxyaLoop™ Bio-Absorbable Bone Anchor [510(k) Number K041698]

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 is designed with a corkscrew style thread 6.5 mm in diameter, 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. Axya Medical believes that the accessory instruments are Class I Manual Surgical Instruments and are exempt from the premarket Notification regulations. The Axya Model 6500 Bio-Absorbable Bone Anchor is prethreaded with polypropylene monofilament, nylon, braided polyester, and braided polyethylene suture material.

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Kospso page 24

The Model 6500 Bio-Absorbable Bone Anchor is designed for use in both standard open
t the Model of the state the limited in (arthreasenia) surgical procedures The Model 6500 Blo-Absorbable Dono Anoner 16 access and in mical procedures.
surgical procedures and in minimally invasive (arthroscopic) surgical procedures.

# Intended Use (Indications)

The Axya Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing in The Axya Model 0500 AxyaLoop - Blo Fissone in the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular
Shoulder: Rotator cuff, Bankart, and Caseulalabrel reconstruction Shoulder: Rolator curi, Bankart, and OEA: "Tocler." Total 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 Uinar 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 6500 Bio-Absorbable Bone Anchor I his submission supports the position that the new clevices, including the Axya Model is substantially equivalent to a number or provincial ( on ber K041698), the Arthrex inc. Bio-5000 AxyaLoop Blo-ADSOrbable Bone Anchor [601(k) Number K003227] and the Market Corkscroable Corkscrew Model AR-1920 absorbable Gonsorew Model Arheaded Suture Anchor [510(K) K021883].
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 l he \$10(K) Notice contains summance of m. M.S. 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 6500 i he data presented demonstrate that the anoner pared favorably with the predicate device of similar
AxyaLoop Bio-Absorbable Bone Anchor compared favor was prodominately the AxyaLoop Blo-Absolbable Bone Anchor ochpared 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 The single-patient-use components of the bone anonor system were and by the original suture manufacturer.

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KOS1250 page 343

## Conclusions

Axya Medical, Inc. believes that the information provided establishes that similar legally Axya Medical, Inc. believes that me innical proviced oscas the Axya Model 6500 Biomarketed have been used for the same clinical applications as the Axya Model 6500 Biomarketed have been used for me same clinical as ano na jo ra je ranicated have an
Absorbable Bone Anchor. The materials from which the Axya have bee Absorbable Bone Anchor. The materials indir the Axya done is table is the management of the management of the maye been
established history of the Hardin He FDA guidence established history of aco in moable FDA guidelines.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

JUN 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Fenton, Jr. President Axya Medical, Inc. 100 Cummings Center Suite 444C Beverly, Massachusetts 01915

Re: K051250

KU51230
Trade/Device Name: Axya, Model 6500 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: May 16, 2005 Received: May 18, 2005

Dear Mr. Fenton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rQtry pressesion is substantially equivalent (for the indications felerenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosure) to regally namest date of the Medical Device Americans, or to commerce pror to May 20, 1978, the exactions of the Federal Food. Drug, devices mat have been recuired in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require of the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (see above) this. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to sach additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pourses oncerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issuates of a complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any rederal statutes and regulations ancluding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, news as a manufacturing practice requirements as set CFN Fatt 807), laocimg (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Paul Fenton, Jr.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse of substantial equivalence of your device to a legally prematted 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 If you desire specific acriver is 101 ) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Wher general information on your responsibilities under the Act may be obtained from the Other general mionmation on your 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,

Miriam Provost, Ph.D.

Acting 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): K

Kory 1250

Device Name: Axya, Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor

Indications For Use:

The Axya Model 6500 AxyaLoop™ Bio-Absorbable Bone Anchor is indicated for securing The Axya Model 8000 / Myazs of the following applications:

Shoulder: Rotator cuff, Bankart, and SLAP lesion repair, Biceps tenodesis, Acromio-Shoulder. Kotator curi, Dankart, and CEAR Tocher 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, Illiotibial 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 No
(21 CFR 807 Subpart C)

(Please do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CD
Stupt Elwdu

Division of General, Restorative, and Neurological Devices

4

510(k) Number K051250