KINEX BIOACTIVE

K130392 · Globus Medical, Inc. · MQV · Aug 15, 2013 · Orthopedic

Device Facts

• Record ID: K130392
• Device Name: KINEX BIOACTIVE
• Applicant: Globus Medical, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Aug 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KINEX™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEX™ Plus Putty and KINEX™ Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX™ Strip, KINEX™ Plus Strip, KINEX™ Putty and KINEX™ Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

Device Story

Resorbable bone void filler; osteoconductive and osteostimulative material; guides bone regeneration. Composed of bioglass, collagen, and hyaluronic acid. Available in putty, gel, and strip forms. Used by surgeons to fill bony voids or gaps in extremities, pelvis, and spine; requires combination with bone marrow aspirate. Implant resorbs over time; replaced by host bone during healing. Provides scaffold for new bone growth in apposition to implant surfaces.

Clinical Evidence

No clinical data. Evidence consists of in vivo performance testing using a tibia defect model and a posterolateral spine fusion model, alongside biocompatibility testing conducted per FDA Class II Special Controls guidance.

Technological Characteristics

Resorbable bone void filler. Materials: bioglass (ASTM F1538), collagen (ASTM F2212), and hyaluronic acid. Forms: putty, gel, strip. Osteoconductive and osteostimulative. No electronic components or software.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, pelvis, and spine) requiring bone void filler or autograft extender. Not for use in defects intrinsic to bony structure stability. Must be combined with bone marrow aspirate.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Vitoss® BA Bioactive BGS (K103173 & K994337)
• NovaBone® Bioactive Bone Graft (K080009)
• InQu® (Bone Void Filler) (K103799)

Submission Summary (Full Text)

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# 510(k) Summary: KINEX™ Bioactive

| Company:<br>Contact: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>610-930-1800<br>Christina Kichula |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | AU6 1 5 201?<br>Group Manager, Regulatory Affairs |
| Date Prepared: | February 12, 2013 |
| Device Name: | KINEX™ Bioactive |
| Classification: | Per 21 CFR as follows:<br>§888.3045 Resorbable Calcium Salt Bone Void Filler<br>Product Codes: MQV<br>Requlatory Class: II, Panel Code 87 |
| Predicate(s): | Vitoss® BA Bioactive BGS K103173 & K994337<br>NovaBone® Bioactive Bone Graft K080009<br>InQu® (Bone Void Filler) K103799 |

#### Purpose:

The purpose of this submission is to request clearance of the KINEX™ Bioactive.

#### Device Description:

KINEX™ Bigactive is a resorbable bone void filler for the repair of bony defects. It is an osteoconductive and osteostimulative material that guides bone regeneration. When KINEX™ is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by KINEX™.

KINEX™ implants consist of bioglass (per ASTM F1538), collagen (per ASTM F2212), and hyaluronic acid, and are available in putty, gel, and strip forms to accommodate surgical and anatomical needs.

#### Indication for Use:

KINEX™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEX™ Plus Putty and KINEX™ Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX™ Strip, KINEX™ Plus Strip, KINEX™ Putty and KINEX™ Gel are intended to be gently packed into bony voids or gaps of the skeletal system

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(i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

## Performance Data:

In vivo performance testing (tibia defect model and posterolateral spine fusion model) and biocompatibility testing were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June 2, 2003. Performance data demonstrates substantial equivalence to the predicate device.

## Basis of Substantial Equivalence:

KINEX™ Bioactive is similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device(s). KINEX™ implants are as safe, as effective, and perform as well as or better than the predicate devices.

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

August 15, 2013

Ms. Christina Kichula Group Manager. Regulatory Affairs Globus Medical Incorporated 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K130392

Trade/Device Name: KINEX™ Bjoactive Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: June 28, 2013 Received: July 1, 2013

Dear Ms. Kichula:

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. Ilisting 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 – Ms. Christina Kichula

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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 yours,

# Ering Seith

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 Statement

510(k) Number: K130392

Device Name: KINEX™ Bioactive

## INDICATIONS:

KINEX™ Bioactive is intended for use as a bone void filler and autograft extender for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. KINEX™ Plus Putty and KINEX™ Plus Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine) and should be combined with bone marrow aspirate. KINEX™ Strip, KINEX™ Plus Strip, KINEX™ Putty and KINEX™ Gel are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801.109)

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130392