5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA

K132590 · ArthroCare Corporation · MBI · Sep 17, 2013 · Orthopedic

Device Facts

• Record ID: K132590
• Device Name: 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA
• Applicant: ArthroCare Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Sep 17, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MultiFIX S Knotless Fixation Device is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon reattachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Device Story

MultiFIX S Knotless Fixation System is an implantable bone anchor with a disposable inserter handle; used in arthroscopic and orthopedic soft tissue-to-bone fixation. Device eliminates need for manual surgical knots. System comprises PEEK Optima anchor preloaded on inserter. Surgeon performs procedure arthroscopically; anchor utilizes interference fit (threaded screw) for bone locking and plug/cylinder compression for suture locking. Output is secure tissue fixation. Benefits include simplified surgical technique and reliable fixation. Device is for professional use by surgeons in clinical/OR settings.

Clinical Evidence

No clinical or animal data included. Bench testing only.

Technological Characteristics

Implantable bone anchor; material: Invibio PEEK Optima; suture: No. 2 UHMWPE. Locking mechanism: interference fit (threaded screw) for bone, plug/cylinder compression for suture. Dimensions: 5.5mm/6.5mm diameter, 291mm length. Sterilization: irradiation. Single-use.

Indications for Use

Indicated for fixation of soft tissue to bone in orthopedic procedures including shoulder (e.g., Bankart, rotator cuff, SLAP), ankle (e.g., instability, Achilles repair), foot (hallux valgus), elbow (tennis elbow, biceps reattachment), and knee (e.g., ligament/tendon reattachment, extra-capsular repairs).

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

• MultiFIX® S Knotless Fixation System (K131182)

Submission Summary (Full Text)

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K132590 (1/3)

# 510(k) Summary

ArthroCare® Corporation MultiFIX® S Knotless Fixation System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

### General Information

| Submitter Name: | ArthroCare Corporation |
|-----------------|--------------------------------------------------------------------------------------------------|
| Address | 7000 West William Cannon Drive<br>Austin, TX 78735 |
| Contact Person: | Laura Kasperowicz<br>Sr. Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | August 16, 2013 |

SEP 17 2013

# Device Name

| Proprietary Name: | MultiFIX® S Knotless Fixation System | |
|----------------------|----------------------------------------------------|--|
| Common Name: | Bone Anchor | |
| Classification Name: | Smooth or threaded metallic bone fixation fastener | |
| Device Class: | Class II | |
| Product Code: | MBI | |
| CFR Section: | 21 CFR 888.3040 | |

### Predicate Device

MultiFIX® S Knotless Fixation System: K131182 (cleared July 29, 2013)

# Description

The MultiFIX S Knotless Fixation System (MultiFIX S) is an implantable bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. The MultiFIX S is a knotless fixation device, meaning that manually tying surgical knots is not necessary for the fixation of suture to tissue.

The MultiFIX S consists of two primary parts: an implantable bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

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Image /page/1/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized wave-like design on the left, followed by the word "ArthroCare" in a bold, sans-serif font. The wave design is made up of several curved lines that create a sense of motion. The overall design is simple and modern.

The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by irradiation. Both the anchor and inserter are designed for single use only.

The MultiFIX S Knotless Fixation System consists of the bone anchor and associated instruments for implanting the bone anchor. In accordance with the ArthroCare Product Development Process, testing was performed to demonstrate the proposed device is substantially equivalent to the predicate device.

# Intended Use/Indications For Use

The MultiFIX S Knotless Fixation Device is indicated for use in fixation of soft tissue to bone.

Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

#### Non-Clinical Data

Bench testing was performed on both the proposed and predicate devices. The test results demonstrate that the MultiFIX S meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling.

#### Clinical Data

No clinical or animal data are included in this submission.

### Summary

All testing demonstrates that the MultiF1X S performs as intended and has acceptable mechanical properties when used in accordance with its labeling.

As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the MultiFIX S Knotless Fixation System is substantially equivalent. The minor differences between the proposed MultiFIX S and predicate device do not raise any new questions of safety or effectiveness.

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·

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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

| | Predicate Device<br>MultiFIX S<br>(K131182) | Proposed Device<br>MultiFIX S |
|---------------------------|---------------------------------------------|-------------------------------|
| Characteristics | | |
| Intended Use | Fixation of soft tissue to bone | Same |
| Delivery Method | Arthroscopic and Limited Access | Same |
| How Supplied | Sterile | Same |
| Suture Material | No. 2 UHMWPE Suture | Same |
| Anchor Material | Invibio PEEK Optima® | Same |
| Design Technology | Pound in Anchor with screw | Same |
| Bone Locking Mechanism | Interference Fit<br>(threaded screw) | Same |
| Suture Locking Mechanism | Plug/Cylinder Compression | Same |
| # of Suture Legs | 2, 3 or 4 | Same |
| Diameter of Cortical Lock | 5.5 mm & 6.5 mm | Same |
| Anchor Deployed Length | 20 to 23 mm | Same |
| Device Length | 299mm | 291mm |
| Sterilization Method | Irradiation | Same |
| Packaging | Sterile / Thermoform Tray with Tyvek Lid | Same |

:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which is a common symbol associated with the department.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2013

ArthroCare Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

Re: K132590

Trade/Device Name: MultiFIX® S Knotless Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 16, 2013 Received: August 19, 2013

Dear Mr. Dhority:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Mr. Mitchell Dhority

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Mark Nimelkerson -S

- Mark N. Melkerson Director Division of Orthopedic 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_132590

Device Name: MultiFIX® S Knotless Fixation System

### Indications for Use:

The MultiFIX S is indicated for use in fixation of soft tissue to bone.

Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction. ITB tenodesis; patellar ligament and tendon avulsions

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

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