MultiFIX S Ultra Knotless Fixation System

K153669 · Arthocare Corporation · MBI · Jan 19, 2016 · Orthopedic

Device Facts

• Record ID: K153669
• Device Name: MultiFIX S Ultra Knotless Fixation System
• Applicant: Arthocare Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Jan 19, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MultiFIX S Ultra 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

Implantable bone anchor system for arthroscopic/orthopedic soft tissue-to-bone fixation; eliminates manual surgical knot tying. System comprises PEEK anchor preloaded on disposable inserter handle. Surgeon inserts anchor into bone; utilizes interference fit for bone locking and plug/cylinder compression for suture locking. Used in shoulder, ankle, foot, elbow, and knee procedures. Provides secure fixation to facilitate tissue healing. Single-use, sterile, irradiation-sterilized.

Clinical Evidence

Bench testing only. In vitro testing per FDA Guidance (April 1996) included static and cyclic fatigue testing in simulated bone substrate. Design verification and simulated use testing confirmed performance specifications met.

Technological Characteristics

Materials: Invibio PEEK Optima anchor. Design: Pound-in anchor with threaded screw interference fit; plug/cylinder compression suture locking. Dimensions: 5.5mm/6.5mm cortical lock diameter; 20-23mm deployed length. Sterilization: Irradiation. Packaging: Thermoform tray with Tyvek lid. Single-use.

Indications for Use

Indicated for soft tissue to bone fixation in orthopedic/arthroscopic procedures including shoulder, ankle, foot, elbow, and knee repairs. Applicable to patients requiring ligament, tendon, or capsule reconstruction/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® S Knotless Fixation System (K151660)

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

January 19, 2016

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

Re: K153669

Trade/Device Name: MultiFIX® S Ultra 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: December 18, 2015 Received: December 21, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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,

# Lori A. Wiggins -S

for

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) K153669

Device Name MultiFIX S Ultra Knotless Fixation System

Indications for Use (Describe)

The MultiFIX S Ultra 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 shiftleapsulelabral 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

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the company name "ArthroCare" on the right. The graphic is made up of several curved lines in a maroon color, arranged to create a sense of movement or flow. The text "ArthroCare" is written in a dark gray, sans-serif font, with the registered trademark symbol "®" appearing in superscript next to the word "Care".

# 510(k) Summary

# ArthroCare® Corporation

MultiFIX® S Ultra 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, 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: | December 18, 2015 | |
| Device Name | | |
| Proprietary Name: | MultiFIX® S Ultra 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: K151660 (cleared July 16, 2015)

#### Descrintion

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

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

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Image /page/4/Picture/1 description: The image shows the logo for ArthroCare. The logo consists of a stylized, abstract symbol on the left and the word "ArthroCare" on the right. The symbol is made up of several curved lines that are arranged in a circular shape. The word "ArthroCare" is written in a sans-serif font and is in a dark gray color. There is a registered trademark symbol to the right of the word "ArthroCare".

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 S Ultra 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 in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices which will be promoted for use with the MultiFIX S Ultra system in order to affirm safety and effectiveness.

The test results demonstrate that the proposed MultiFIX S Ultra 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 S Ultra 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 S Ultra Knotless Fixation System is substantially equivalent. The minor differences between the proposed MultiFIX S Ultra 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 circular graphic on the left and the word "ArthroCare" on the right. The circular graphic is made up of several curved red lines. The word "ArthroCare" is written in a dark gray sans-serif font, and there is a registered trademark symbol after the word.

| Comparison of Technological Characteristics | | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Characteristics | Predicate Device<br>MultiFIX S<br>(K151660) | Proposed Device<br>MultiFIX S Ultra |
| 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 Thread<br>and/or UltraBraid® Suture Thread and/or<br>UltraTape® | Same |
| # of Suture Legs | 2, 3 or 4 Suture Thread Legs<br>or a maximum of 2 Suture Thread Legs<br>and 2 Suture Tape Legs | 2, 3 or 4 Suture Thread Legs<br>or a maximum of 4 Suture Tape Legs |
| Suture Snare | Single Loop | Dual Loop |
| Anchor Material | Invibio PEEK Optima® with laser marking | 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 |
| Diameter of Cortical Lock | 5.5 mm & 6.5 mm | Same |
| Anchor Deployed Length | 20 to 23 mm | Same |
| Device Length | 291mm | Same |
| Sterilization Method | Irradiation | Same |
| Packaging | Sterile / Thermoform Tray with Tyvek Lid | Same |
| Accessory Devices<br>Promoted for use with the<br>MultiFIX S System | Insertion Guide with Obturator, Bone<br>Punch, Anchor Extraction Tool, Reusable<br>FirstPass Suture Passer, SmartStitch Suture<br>Passer, PerfectPasser Suture Passer | Same and FirstPass® ST Suture Passer |