OrthoButton CL

K160655 · Riverpoint Medical · MBI · Jun 3, 2016 · Orthopedic

Device Facts

• Record ID: K160655
• Device Name: OrthoButton CL
• Applicant: Riverpoint Medical
• Product Code: MBI · Orthopedic
• Decision Date: Jun 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Riverpoint Medical Orthobutton CL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

Device Story

OrthoButton CL is a bone fixation fastener used in orthopedic ligament or tendon reconstruction. Device consists of a braided ultra-high molecular weight polyethylene (UHMWPE) continuous loop attached to a titanium plate. Used by surgeons in clinical settings to secure soft tissue to bone. The device provides mechanical fixation; surgeon threads the loop through tissue and anchors it using the plate. Single-use, sterile device. Benefits include stable fixation of soft tissue to bone during healing.

Clinical Evidence

Bench testing only. Included sterilization validation (ISO 11135-1:2007), biocompatibility testing (ISO 10993-1:2009), stability/packaging testing (ISO 11607-1:2006), and simulated use usability validation (EN 62366:2008). All acceptance criteria were met.

Technological Characteristics

Materials: Braided UHMWPE loop and Ti-6Al-4V ELI titanium plate (ASTM F136). Dimensions: 10mm-60mm loop lengths. Sterilization: Ethylene oxide. Single-use. Mechanical fixation device.

Indications for Use

Indicated for patients undergoing orthopedic procedures requiring ligament or tendon reconstruction for the fixation of bone and soft tissue.

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

• Parcus Medical LLC, GFS Mini (K133757)

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

June 3, 2016

Riverpoint Medical Mr. Edwin Anderson Director of Quality and Regulatory 825 NE 25th Avenue Portland, Oregon 97232

Re: K160655

Trade/Device Name: OrthoButton CL® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 4, 2016 Received: March 8, 2016

Dear Mr. Anderson:

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/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 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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## Indications for Use Statement

510(k) Number (if known): K160655

Device Name: OrthoButton CL®

Indications for Use:

The Riverpoint Medical OrthoButton CL® is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) SUMMARY

## Riverpoint Medical's OrthoButton CL

## Submitter Information

| Submitter's Name: | Riverpoint Medical |
|----------------------|----------------------------------------|
| Address: | 825 NE 25th Ave.<br>Portland, OR 97232 |
| Phone Number: | [phone] or 866 445-4923 |
| Fax Number: | [phone] |
| Registration Number: | 3006981798 |
| Contact Person: | Edwin Anderson<br>[phone] |
| Date of Preparation: | March 4th, 2016 |

#### Device Name

| Trade Name: | OrthoButton CL |
|------------------------|-------------------------------------------------|
| Common or Usual Names: | Suture Retention Device, Button Loop |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |

#### Device Classification

| FDA Class: | Class II |
|-------------------------|--------------------------------------|
| Product Classification: | 888.3040 |
| Classification Code: | MBI |
| Review Panel: | Orthopedic |
| Premarket Review | Office of Device Evaluation |
| | Division of Orthopedic Devices (DOD) |
| | Joint and Fixation Devices Branch 1 |

#### Predicate Devices

K133757 – Parcus Medical LLC, GFS Mini.

#### Device Description:

The Riverpoint Medical OrthoButton CL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") continuous loop combined with a titanium (Ti-6AI-4V ELI per ASTM F136) plate. The device is provided sterile for single use.

#### Intended Use / Indications for Use

The Riverpoint Medical Orthobutton CL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.

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Image /page/4/Picture/0 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters "RP" in white inside of a green rounded square. To the right of the square is the text "RIVERPOINT" in black, with the word "MEDICAL" in smaller letters underneath.

# Technological Characteristics

The Riverpoint Medical Orthobutton CL is provided sterilized via ethylene oxide, for single use. The device is available in 10mm-60mm loop length configurations.

## Substantial Equivalence

The Riverpoint Medical OrthoButton CL has been designed and manufactured to be substantially equivalent to the Parcus Medical GFS Mini ("predicate device") for all aspects of safety and effectiveness. The Riverpoint Medical OrthoButton CL and predicate device have the same intended use and indications, principles of operation, and have similar technological characteristics. Furthermore, the Riverpoint Medical Orthobutton CL and the predicate device have the same materials of construction, button shape, packaging materials, and sterilization methods. In conclusion, the Riverpoint Medical OrthoButton CL is substantially equivalent to the Parcus Medical GFS Mini.

## Performance Data

Non-clinical performance testing for the Riverpoint Medical Orthobutton CL included sterilization validation per ISO11135-1:2007 - Sterilization of Health Care Products Ethylene Oxide Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices, biocompatibility testing per ISO10993-1:2009 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems, and a simulated use Usability Validation performed per EN62366: 2008-Medical devices - Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical Orthobutton CL performed as intended.

## Conclusion

Based on the information provided within this 510(k) submission, the proposed Orthobutton CL does not raise significant questions of safety or effectiveness and may be considered substantially equivalent to the predicate device.