3.9MM REELX STT SUTURE ANCHOR SYSTEM

K120824 · Stryker Corp. · MBI · Jul 18, 2012 · Orthopedic

Device Facts

• Record ID: K120824
• Device Name: 3.9MM REELX STT SUTURE ANCHOR SYSTEM
• Applicant: Stryker Corp.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures. Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift/Capsulolabral Reconstruction Knee: Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Illiotibial Band Tenodesis Foot and Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot Reconstruction Metatarsal Ligament Repair Elbow: Biceps Tendon Reattachment The ReelX STT Suture Anchor is intended for single-use only.

Device Story

Suture anchor system for soft tissue-to-bone fixation; comprises PEEK polymer and titanium anchor preloaded on disposable inserter. Surgeon inserts anchor into bone; design allows post-insertion tension adjustment of tissue. Used in orthopedic procedures (shoulder, knee, foot/ankle, elbow) by surgeons. Provides secure fixation; facilitates tissue repair; improves clinical outcomes for ligament/tendon reattachment.

Clinical Evidence

No clinical data; bench testing only. Ultimate tensile strength testing characterized insertion and fixation strength compared to predicate devices.

Technological Characteristics

Materials: PEEK polymer and titanium. Form factor: 3.9mm suture anchor preloaded on disposable inserter. Principle: Mechanical bone fixation fastener. Single-use.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot, ankle, knee, and elbow procedures, including rotator cuff, Bankart, SLAP, biceps, ligament, and tendon repairs/reconstructions. For single-use only.

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

• Spin-Loc Suture Anchor System (K090530)
• Arthrex PushLock (K051219)
• DePuy Mitek Panalok Anchor (K970896)

Submission Summary (Full Text)

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K120824(1/3)

#### 510(k) Summary of Safety and Effectiveness

# JUL 18 2012

| Proprietary Name: | Stryker ReelX STTTM Suture Anchor System Line<br>Extension |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener<br>21 CFR §888.3040 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | MBI: Fastener, Fixation, Nondegradable, Soft Tissue |
| For Information Contact: | Kelly Kucharczyk<br>Regulatory Affairs Associate<br>Howmedica Osteonics Corp.<br>3201 East 3rd Ave.<br>Denver, CO 80206<br>Phone: [phone]; Fax [phone]<br>Email: [e-mail] |
| Legally Marketed Devices to Which<br>Substantial Equivalence Is Claimed: | K090530 - Spin-Loc Suture Anchor System (legally<br>marketed as Stryker ReelX STT Suture Anchor)<br>K051219 - Arthrex PushLock<br>K970896 - DePuy Mitek Panalok Anchor |
| Date Prepared: | July 11, 2012 |

#### Purpose

Stryker currently offers a 5.5mm ReelX STT Suture Anchor (cleared as the Spin-Loc Suture Anchor System- K090530). This submission serves to introduce an additional 3.9mm ReelX STT Suture Anchor to the market.

#### Description

The ReelX STT Suture Anchor System Line Extension (here forth referred to as the 3.9mm ReelX STT Suture Anchor) is an anchor designed to facilitate fixation of soft tissue to bone. The system is comprised of a PEEK polymer and titanium suture anchor preloaded on a disposable inserter. This anchor design allows the surgeon to adjust the tension of the tissue after the anchor has been inserted in bone.

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#### Intended Use

The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures.

#### Indications

The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:

| Shoulder: | Rotator Cuff Repair |
|-----------------|---------------------------------------------|
| | Bankart Repair |
| | SLAP Lesion Repair |
| | Biceps Tenodesis |
| | Acromio-Clavicular Separation Repair |
| | Deltoid Repair |
| | Capsular Shift/Capsulolabral Reconstruction |
| Knee: | Medial Collateral Ligament Repair |
| | Lateral Collateral Ligament Repair |
| | Patellar Tendon Repair |
| | Posterior Oblique Ligament Repair |
| | Illiotibial Band Tenodesis |
| Foot and Ankle: | Lateral Stabilization |
| | Medial Stabilization |
| | Achilles Tendon Repair |
| | Hallux Valgus Reconstruction |
| | Midfoot Reconstruction |
| | Metatarsal Ligament Repair |
| Elbow: | Biceps Tendon Reattachment |

The ReelX STT Suture Anchor is intended for single-use only.

#### Summary of Technologies

The proposed device is substantially equivalent to other commercially available soft tissue anchors in regard to intended use. design. materials of construct, performance attributes, and operational principles. The following devices are examples of predicate systems: the Spin-Loc Suture Anchor System (marketed as and here forth referred to as the 5.5mm ReelX STT Suture Anchor) and the Arthrex PushLock.

#

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### Non-Clinical Testing

Non-clinical ultimate tensile strength testing was performed to characterize both the insertion strength and fixation strength of the 3.9mm ReeIX STT Suture Anchor as compared to the predicate devices identified within this premarket notification. The results of this testing indicate that the performance of the 3.9mm ReelX STT Suture Anchor System is substantially equivalent to the predicate devices, and the subject anchors will function within the intended use.

#### Clinical Testing

Clinical testing was not required for this submission.

#### Conclusion

The 3.9mm ReeIX STT Suture Anchor System is substantially equivalent to the predicate devices identified in this premarket notification.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 symbol that resembles an abstract caduceus or a representation of human services.

#### Public Health Service

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

Stryker Corporation % Ms. Kelly Kucharczyk Regulatory Affairs Associate 3201 East 310 Avenue Denver, Colorado 80206

## JUL 18 2012

Re: K120824

Trade/Device Name: Stryker ReelX STT™ Suture Anchor System Line Extension Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fasterner Regulatory Class: II Product Code: MBI Dated: June 29, 2012 Received: July 01, 2012

Dear Ms. Kucharczyk:

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

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### Page 2 - Ms. Kelly Kucharczyk

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

Erinell Keith

ArMark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K1208241111)

#### Indications for Use

510(k) Number (if known): K120824

Device Name:

### Stryker ReelX STT™ Suture Anchor System Line Extension

The ReelX STT Suture Anchor System is indicated for use in fixating suture or soft tissue fixation to bone in the shoulder, foot and ankle, knee, and elbow. The anchor is indicated for use in the following procedures:

Shoulder:

Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift/Capsulolabral Reconstruction

Knee:

Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Illiotibial Band Tenodesis

Lateral Stabilization Foot and Ankle: Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot Reconstruction Metatarsal Ligament Repair

Biceps Tendon Reattachment Elbow:

The ReelX STT Suture Anchor System is intended for single-use only.

| Prescription Use | xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx<br>(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |
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| | | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | |
| Page 1 of 1 | | | (Division Sign-Off)<br>Division of Surgical, Orthopedic,<br>and Restorative Devices | |

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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