INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000

K051362 · Inion OY · MAI · Aug 4, 2005 · Orthopedic

Device Facts

• Record ID: K051362
• Device Name: INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
• Applicant: Inion OY
• Product Code: MAI · Orthopedic
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INION ANCHRON™ BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows: A. Open procedures: 1. Shoulder: • Bankart repair • SLAP lesion repair • Rotator cuff repair • Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site • Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus • Biceps tenodesis • Acromio-clavicular separation • Biceps tendon reattachment 2. Elbow: • Achilles tendon repair/reconstruction 3. Ankle: • Lateral stabilization • Medial stabilization at the medial talus site • Medial collateral ligament repair 4. Knee: • Lateral collateral ligament repair • Joint capsule closure to anterior proximal tibia • Posterior oblique ligament or joint capsule to tibia repair • Extra capsular reconstruction / ITB tenodesis • Patellar ligament and tendon avulsion repairs B. Arthroscopic procedures: 1. Shoulder: Bankart repair • SLAP lesion repair • Rotator cuff repair • Capsule shift repair (glenoid rim)

Device Story

Biodegradable suture anchor system for soft tissue-to-bone fixation. System comprises PLDLA co-polymer anchor, non-degradable polyester sutures, stainless steel needles, and single-use inserter. Used by surgeons in OR for open or arthroscopic orthopedic procedures. Anchor provides mechanical fixation; bioresorption occurs within three years; strength retention up to 16 weeks. Device facilitates tissue healing by securing soft tissue to bone during recovery period.

Clinical Evidence

Bench testing only. In vitro testing confirmed strength retention up to 16 weeks and bioresorption within three years.

Technological Characteristics

Material: PLDLA co-polymer anchor, polyester sutures, stainless steel needles. Dimensions: 3.0 mm x 8.5 mm. Sterile, nonpyrogenic, single-use. Shelf life: 3 years.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation in open or arthroscopic procedures, including shoulder (Bankart, SLAP, rotator cuff, biceps, AC separation), elbow (Achilles repair), ankle (lateral/medial stabilization), and knee (ligament/capsule repairs). Requires post-operative immobilization.

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

• Modified Mitek 3.5 mm Panalok Wedge Absorbable Suture Anchor System (K970896)

Submission Summary (Full Text)

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# AUG 4 - 2005

## 510(k) SUMMARY for INION ANCHRON ™ Biodegradable Anchor System

### MANUFACTURER

Inion Ltd., Lääkärinkatu 2, FIN-33520 Tampere, FINLAND

#### Contact Person

Hanna Marttila, Regulatory Affairs Director Lääkärinkatu 2, FIN-33520 Tampere Phone: [phone] Fax: [phone] [e-mail]

#### DEVICE NAME

Trade name: Inion ANCHRON™ Biodegradable Anchor System Common/Usual Name: Suture anchor

#### ESTABLISHMENT REGISTRATION NUMBER 9710629

## DEVICE CLASSIFICATION AND PRODUCT CODE

Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Regulation Name: Fastener, fixation, biodegradable, soft tissue Regulatory Class: Class II Product Code: MAI

## PREDICATE DEVICE

Modified Mitek 3.5 mm Panalok Wedge Absorbable Suture Anchor System (K970896)

## CONFORMANCE WITH PERFORMANCE STANDARDS

No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.

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Image /page/1/Picture/0 description: The image shows the word "INION" in large, bold, white letters against a black background. Below the word "INION" is the phrase "Intelligent Solution" in a smaller font size, also in white. The overall design is simple and modern, with a focus on the company name and its tagline.

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IC051362

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## DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

Inion ANCHRON™ Biodegradable Anchor System is intended to allow secure fixation of soft tissue to bone in conjunction with appropriate immobilization. The system consists of degradable suture anchor made of co-polymers PLDLA, non-degradable polyester sutures with stainless steel needles, and a single-use suture anchor inserter. The suture anchors are dyed green. Based on in vitro testing: the suture anchors retain most of their strength up to 16 weeks and gradually loose their strength thereafter; and bioresorption takes place within three years.

Inion ANCHRON™ Biodegradable Suture Anchor is provided in size 3.0 mm x 8.5 mm.

Inion ANCHRON™ Biodegradable Anchor system is provided sterile to the user and is nonpyrogenic. The shelf life of the device is 3 years.

# SUBSTANTIAL EQUIVALENCE TO MARKETED PRODUCTS

Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion ANCHRON™ Biodegradable Anchor System are substantially equivalent with the predicate device Mitek 3.5 mm Panalok Wedge Absorbable Suture Anchor System (K970896).

Inion ANCHRON™ Biodegradable Anchor System is substantially equivalent to predicate Class II devices used for soft tissue to bone fixation with appropriate postoperative immobilization because the differences between Inion ANCHRON™ Biodegradable Anchor System and the predicate devices do not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 4 - 2005

Ms. Hanna Marttila Regulatory Affairs Director Inion Ltd. Lääkärinkatu 2 Tampere, Finland 33520

Re: K051362 Trade/Device Name: Inion ANCHRON™ Biodegradable Anchor System 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 23, 2005 Received: May 25, 2005

Dear Ms. Marttila:

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 - Ms. Hanna Marttila

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), 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 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 vours

Stipt Rhodes

Mark N. Melkerson 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): K051362

Inion Anchron™ Biodegradable Anchor System Device Name:

Indications for Use:

The INION ANCHRON™ BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows: A. Open procedures:

1. Shoulder:• Bankart repair

- · SLAP lesion repair
- · Rotator cuff repair
- · Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site
- · Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
- Biceps tenodesis
- · Acromio-clavicular separation
- · Biceps tendon reattachment 2. Elbow:
- · Achilles tendon repair/reconstruction 3. Ankle:
- · Lateral stabilization
- · Medial stabilization at the medial talus site
- Medial collateral ligament repair 4. Knee:
- · Lateral collateral ligament repair
- · Joint capsule closure to anterior proximal tibia
- · Posterior oblique ligament or joint capsule to tibia repair
- · Extra capsular reconstruction / ITB tenodesis
- · Patellar ligament and tendon avulsion repairs
- B. Arthroscopic procedures:
- 1. Shoulder: Bankart repair
- · SLAP lesion repair
- · Rotator cuff repair
- · Capsule shift repair (glenoid rim)

Concurrence of CDR

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

(Division Sign-Off

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Division of General, Restorative,

and Neuro gical Devices