(181 days)
No
The 510(k) summary describes a resorbable bone void filler composed of bioglass, collagen, and hyaluronic acid. There is no mention of AI or ML technology in the intended use, device description, or performance studies. The focus is on the material properties and biological interaction of the device.
Yes.
Explanation: The device is intended for use as a bone void filler and autograft extender for voids or gaps in bony structures, to aid in healing and regeneration, which aligns with the definition of a therapeutic device.
No.
The device is a bone void filler intended for repair of bony defects, not for diagnosing conditions.
No
The device description clearly states that KINEX™ Bioactive is a resorbable bone void filler consisting of physical materials (bioglass, collagen, and hyaluronic acid) in putty, gel, and strip forms. This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that KINEX™ Bioactive is a "bone void filler and autograft extender" for filling gaps in bone. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition and function of the device as a material that guides bone regeneration and is replaced by bone during healing. This aligns with a therapeutic device, not a diagnostic one that analyzes samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted into the body to aid in bone repair.
N/A
Intended Use / Indications 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 (i.e., the extremities, pelvis) and should be combined with bone marrow aspirate. KINEX™ resorbs and is replaced with bone during the healing process.
Product codes
MQV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, pelvis, and spine)
skeletal system (i.e., the extremities, pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Vitoss® BA Bioactive BGS K103173, K994337, NovaBone® Bioactive Bone Graft K080009, InQu® (Bone Void Filler) K103799
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
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.(b)
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.
0
510(k) Summary: KINEX™ Bioactive
| Company:
Contact: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800
Christina Kichula |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | AU6 1 5 201?
Group Manager, Regulatory Affairs |
| Date Prepared: | February 12, 2013 |
| Device Name: | KINEX™ Bioactive |
| Classification: | Per 21 CFR as follows:
§888.3045 Resorbable Calcium Salt Bone Void Filler
Product Codes: MQV
Requlatory Class: II, Panel Code 87 |
| Predicate(s): | Vitoss® BA Bioactive BGS K103173 & K994337
NovaBone® Bioactive Bone Graft K080009
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
1
(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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, a common symbol associated with the U.S. government.
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
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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