PULLUP® Adjustable Juxtacortical Fixation Device

K151004 · Sbm Sciences For Bio Materials · MBI · Nov 17, 2015 · Orthopedic

Device Facts

• Record ID: K151004
• Device Name: PULLUP® Adjustable Juxtacortical Fixation Device
• Applicant: Sbm Sciences For Bio Materials
• Product Code: MBI · Orthopedic
• Decision Date: Nov 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.

Device Story

PULLUP® Adjustable Juxtacortical Fixation Device is a surgical implant for ACL reconstruction. It consists of an adjustable nonabsorbable braided loop and a titanium button, preloaded with traction threads. Available in two versions (PULLUP® for 4.5 mm cortical tunnels; PULLUP®XL for 5-10 mm tunnels). Used by orthopedic surgeons in an operating room setting to secure soft tissue grafts to bone. The device is supplied sterile and ready for use. It functions as a mechanical fixation fastener to stabilize the graft during the healing process.

Clinical Evidence

No clinical data has been presented. Substantial equivalence is supported by non-clinical performance testing.

Technological Characteristics

Materials: nonabsorbable braided loop and titanium button. Form factor: adjustable loop system with traction threads. Versions: PULLUP® (4.5 mm tunnels) and PULLUP®XL (5-10 mm tunnels). Sterilization: supplied sterile.

Indications for Use

Indicated for juxtacortical fixation during ACL reconstruction surgery.

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

• TightRope RT (K112990)
• ToggleLoc System (K130033)

Submission Summary (Full Text)

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November 17, 2015

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

SBM Sciences for Bio Materials Mr. Denis Clement CEO Zi Du Monge 65100 Lourdes France

Re: K151004

Trade/Device Name: PULLUP® Adjustable Juxtacortical 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: October 15, 2015 Received: October 15, 2015

Dear Mr. Clement:

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. Denis Clement

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 vours.

# 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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### Traditional 510(k) PULLUP® Adjustable Juxtacortical Fixation System

Image /page/2/Picture/2 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M in gray, with the words "Science & Bio Materials" written in a smaller font size below the letters. To the right of the letters are four gray triangles pointing to the right. The second triangle from the left has a blue gradient pattern.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

#### 510(k) Number (if known)

#### K151004

Device Name

PULLUP® Adjustable Juxtacortical Fixation Device

Indications for Use (Describe)

The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publiching Sarvascer 3011 x 443-67201 FF

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Image /page/3/Picture/2 description: The image shows the logo for Science & Bio Materials. The logo consists of the letters "SBM" in different shades of gray and blue, with the words "Science & Bio Materials" written in a smaller font size underneath. To the right of the letters are three gray triangles pointing to the right, with the middle triangle having a blue gradient.

## SECTION 5

## 510(k) SUMMARY

## 1. GENERAL INFORMATION

| Type of 510(k) | TRADITIONAL |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | PULLUP® Adjustable Juxtacortical Fixation Device |
| CFR section | 21CFR 888.3040 |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Device panel | ORTHOPEDIC |
| Product Code | MBI |
| Class | II |
| Legally marketed predicate devices | K112990 TightRope RT manufactured by Arthrex, Inc.<br>K130033 ToggleLoc System manufactured by Biomet<br>Manufacturing Corp. |
| Submitter | SCIENCE FOR BIOMATERIALS<br>Sciences et Bio Matériaux<br>ZI du Monge<br>F 65100 LOURDES - FRANCE<br>Registration Number : 3004549189 |
| Contact | Denis CLEMENT, CEO<br>Tel : [phone]<br>Fax : [phone]<br>e-mail : [e-mail]<br>Regulatory contact : Anne COSPIN-LATAPIE<br>e-mail : [e-mail] |

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### Traditional 510(k) PULLUP® Adjustable Juxtacortical Fixation System

Image /page/4/Picture/2 description: The image shows the logo for Science & Bio Materials (SBM). The logo consists of the letters S, B, and M, with the B in a different color than the S and M. Underneath the letters is the text "Science & Bio Materials". To the right of the letters are three triangles, the middle one with a gradient pattern.

## 2. DEVICE DESCRIPTION

The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads.

The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions:

- -PULLUP® for cortical tunnels having a diameter of 4.5 mm
- PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm -

The implant is supplied sterile, ready to use.

## 3. INDICATIONS FOR USE

The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.

### 4. PERFORMANCE DATA

Non clinical performance testing demonstrated that PULLUP® device is as safe, as effective, and performs at least as safely and effectively as its predicate devices. No clinical data has been presented.

## 5. SUBSTANTIAL EQUIVALENCE

The PULLUP® device is substantially equivalent to its predicate devices Arthrex TightRope RT (K112990) and Biomet ToggleLoc (K130033). Verification and validation tests demonstrate that the PULLUP® device is as safe, as effective, and performs as safely and effectively as its predicate device.

Summary preparation date: October 20, 2015