MultiFIX® P Knotless Fixation Device

K151897 · ArthroCare Corporation · MBI · Aug 6, 2015 · Orthopedic

Device Facts

• Record ID: K151897
• Device Name: MultiFIX® P Knotless Fixation Device
• Applicant: ArthroCare Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MultiFIX P 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 attachment. 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

Implantable bone anchor system for arthroscopic soft tissue-to-bone fixation; eliminates manual surgical knot tying. System comprises disposable inserter handle preloaded with PEEK anchor. Surgeon inserts anchor into bone; suture locking achieved via plug/cylinder compression mechanism. Device used in OR by orthopedic surgeons. Provides secure tissue fixation; benefits patient by simplifying procedure and reducing operative time.

Clinical Evidence

No clinical or animal data included. Bench testing only; mechanical properties and performance specifications verified as equivalent to predicate.

Technological Characteristics

Implantable bone anchor; material: Invibio PEEK Optima LT1. Design: pound-in anchor with 6-barb bone locking mechanism and plug/cylinder suture locking. Dimensions: 4.5 mm cortical lock diameter, 14.5 mm deployed length. Suture compatibility: #2 UHMWPE MagnumWire, UltraBraid, and UltraTape. Sterilization: irradiation. Single-use, sterile, packaged in thermoform tray with Tyvek lid.

Indications for Use

Indicated for soft tissue to bone fixation in orthopedic/arthroscopic procedures including shoulder (Bankart, SLAP, rotator cuff, etc.), ankle (instability, Achilles, midfoot), foot (hallux valgus), elbow (tennis elbow, biceps), and knee (ligament/tendon reattachment).

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® P Knotless Fixation Device (K120096)

Submission Summary (Full Text)

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

August 6, 2015

ArthroCare Corporation Ms. Laura Kasperowicz Principle Regulatory Affairs Specialist 15285 Alton Parkway, Suite 200 Irvine, California 92618

Re: K151897

Trade/Device Name: MultiFIX® P Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: July 9, 2015 Received: July 10, 2015

Dear Ms. Kasperowicz,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Laura Kasperowicz

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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| <div align="center"> DEPARTMENT OF HEALTH AND HUMAN SERVICES <br/>Food and Drug Administration <br/><b>Indications for Use</b> </div> | | K151897 Page 1 of 1<br>Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number ( <i>if known</i> ) | K151897 | |
| Device Name | MultiFIX P Knotless Fixation Device | |
| Indications for Use (Describe) | The MultiFIX P 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 attachment. | |
| | 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. | |

| Type of Use ( <i>Select one or both, as applicable</i> ) | <table border="0"><tr><td><div style="display:inline-block; vertical-align:middle;"> <img alt="checkbox" height="12" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAwAAAAMCAYAAABWdVnuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAZdEVYdFNvZnR3YXJlAHBhaW50Lm5ldCA0LjIuMTMEaa6AAAAUSURBVChTY6yIAAQkgE0iB0hmQAwScQIkEgDxkAIElAApsAAAAABJRU5ErkJggg==" width="12"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td><div style="display:inline-block; vertical-align:middle;"> <img alt="checkbox" height="12" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAwAAAAMCAYAAABWdVnuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAZdEVYdFNvZnR3YXJlAHBhaW50Lm5ldCA0LjIuMTMEaa6AAAAUSURBVChTY6yIAAQkgE0iB0hmQAwScQIkEgDxkAIElAApsAAAAABJRU5ErkJggg==" width="12"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <div style="display:inline-block; vertical-align:middle;"> <img alt="checkbox" height="12" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAwAAAAMCAYAAABWdVnuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAZdEVYdFNvZnR3YXJlAHBhaW50Lm5ldCA0LjIuMTMEaa6AAAAUSURBVChTY6yIAAQkgE0iB0hmQAwScQIkEgDxkAIElAApsAAAAABJRU5ErkJggg==" width="12"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle;"> <img alt="checkbox" height="12" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAwAAAAMCAYAAABWdVnuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAZdEVYdFNvZnR3YXJlAHBhaW50Lm5ldCA0LjIuMTMEaa6AAAAUSURBVChTY6yIAAQkgE0iB0hmQAwScQIkEgDxkAIElAApsAAAAABJRU5ErkJggg==" width="12"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block; vertical-align:middle;"> <img alt="checkbox" height="12" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAwAAAAMCAYAAABWdVnuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAZdEVYdFNvZnR3YXJlAHBhaW50Lm5ldCA0LjIuMTMEaa6AAAAUSURBVChTY6yIAAQkgE0iB0hmQAwScQIkEgDxkAIElAApsAAAAABJRU5ErkJggg==" width="12"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| <div style="display:inline-block; vertical-align:middle;"> <img alt="checkbox" height="12" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAwAAAAMCAYAAABWdVnuAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAZdEVYdFNvZnR3YXJlAHBhaW50Lm5ldCA0LjIuMTMEaa6AAAAUSURBVChTY6yIAAQkgE0iB0hmQAwScQIkEgDxkAIElAApsAAAAABJRU5ErkJggg==" width="12"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) | | | |

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# 510(k) Summary

ArthroCare® Corporation

MultiFIX® P Knotless Fixation Device

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, a Smith & Nephew Company |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Address | 15285 Alton Parkway, Suite 200<br>Irvine, CA. 92618 |
| Contact Person: | Laura Kasperowicz<br>Principle Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 9, 2015 |

#### Device Name

| Proprietary Name: | MultiFIX® P Knotless Fixation Device |
|-------------------|--------------------------------------|
|-------------------|--------------------------------------|

| 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® P Knotless Fixation Device: K120096 (cleared March 27, 2012)

#### Description

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

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

# Intended Use/Indications For Use

The MultiFIX P 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 proposed MultiFIX P 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 device when used in accordance with labeling.

# Clinical Data

No clinical or animal data are included in this submission.

# Summary

All testing demonstrates that the proposed MultiFIX P performs as intended and has acceptable mechanical properties when used in accordance with the labeling.

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

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Image /page/5/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a red circular design on the left and the word "ArthroCare" in gray on the right. The circular design is made up of several curved lines that converge at the center. The word "ArthroCare" is written in a sans-serif font, and there is a registered trademark symbol after the word.

| Comparison of Technological Characteristics | | | | |
|--------------------------------------------------|---------------------------------------------|------------------------------------------------------------------------------------------------|--|--|
| Characteristics | Predicate Device<br>MultiFIX P<br>(K120096) | Proposed Device<br>MultiFIX P | | |
| Intended Use | Fixation of soft tissue to bone | Same | | |
| Delivery Method | Arthroscopic and Limited Access | Same | | |
| How Supplied | Sterile | Same | | |
| Brand Name of Qualified<br>Suture | #2 UHMWPE MagnumWire® Suture<br>Thread | #2 UHMWPE MagnumWire® Suture<br>Thread and/or UltraBraid® Suture<br>Thread and/or UltraTape® | | |
| # of Suture Legs<br>(volume of suture qualified) | 2, 3 or 4 Suture Thread Legs | 2, 3 or 4 Suture Thread Legs<br>or a maximum of 2 Suture Thread Legs<br>and 2 Suture Tape Legs | | |
| Suture Snare | Single Loop | Same | | |
| Anchor Material | Invibio PEEK Optima® LT1 | Same | | |
| Design Technology | Pound in Anchor | Same | | |
| Bone Locking Mechanism | 6 barbs | Same | | |
| Suture Locking Mechanism | Plug/Cylinder Compression | Same | | |
| Diameter of Cortical Lock | 4.5 mm | Same | | |
| Anchor Deployed Length | 14.5 mm | Same | | |
| Sterilization Method | Irradiation | Same | | |
| Packaging | Sterile / Thermoform Tray with Tyvek Lid | Same | | |