APATIGHT-TCP BONE GRAFT SUBSTITUTE

K013966 · Cerabio, LLC · MQV · May 16, 2002 · Orthopedic

Device Facts

• Record ID: K013966
• Device Name: APATIGHT-TCP BONE GRAFT SUBSTITUTE
• Applicant: Cerabio, LLC
• Product Code: MQV · Orthopedic
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

Device Story

Apatight-TCP Bone Graft Substitute is a porous, resorbable calcium phosphate implant designed for bone void filling. It features a trabecular structure mimicking human cancellous bone to provide osteoconductive scaffolding. Provided in block or granular forms, the device is implanted by a surgeon into bony defects. Once in contact with viable host bone, it guides three-dimensional bone regeneration; new bone grows into the interconnected pores as the implant resorbs. The device is intended for non-load-bearing voids in the extremities, spine, and pelvis. It benefits patients by facilitating natural bone healing and defect repair.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and an animal model study. Animal study demonstrated the device was well-tolerated, fully integrated into the defect site, and supported complete filling of interconnected pores with new bone at follow-up, with no signs of inflammation or infection.

Technological Characteristics

Porous calcium phosphate (tricalcium phosphate) bone graft substitute. Trabecular structure with multidirectional interconnected porosity. Provided sterile in block and granular forms. Material composition satisfies ASTM standards for implantable tricalcium phosphate. Osteoconductive, resorbable implant.

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Applicable to surgically created osseous defects or defects resulting from traumatic injury.

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™ Scaffold Synthetic Cancellous Bone Void Filler

Submission Summary (Full Text)

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Kolz966 V

#### 510(k) Summary [as required by 21 CFR 807.92(c)] 2

## Submitter's Name / Contact Person

CERAbio, LLC Technology Center N4660 1165th St. Prescott, WI 54021-7644 Contact James J. Cassidy, President

#### General Information

| Trade Name | Apatight-TCP Bone Graft Substitute |
|---------------------|--------------------------------------------------------|
| Common / Usual Name | Bone Void Filler, Bone Graft Substitute |
| Classification Name | Filler, Calcium Sulfate Preformed Pellets |
| Equivalent Device | Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler |

#### Device Description

Apatight–TCP Bone Graft Substitute is a porous calcium phosphate resorbable bone graft substitute for the repair of bony defects. It is an osteoconductive porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is provided sterile in block and granular forms. Apatight-TCP Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When Apatight-TCP Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the calcium phosphate surfaces of the implant, filling the pores with new bone. As the implant resorbs, bone grows into the space previously occupied by the bone graft substitute.

#### Intended Use / Indications

Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

### Substantial Equivalence Comparison

Apatight-TCP was shown by analysis of available information to be nearly identical in intended use and equivalent in materials and configuration to the predicate device. The material chemical composition also satisfies an ASTM standard for implantable tricalcium phosphate. Results of performance testing in an animal model showed that the device was well-tolerated and completely integrated into the defect site. The interconnected porosity of the Apatight-TCP implants was completely filled with new bone at the follow-up time points and there were no signs of inflammation or infection in any Apatight-TCP treated animal. The information presented demonstrated that the Apatight-TCP Bone Graft Substitute is substantially equivalent to the currently marketed predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

**MAY 16 2002**

James J. Cassidy, Ph.D. President CERAbio, LLC Technology Center N4660 1165th St. Prescott, Wisconsin 54021-7644

Re: K013966

Trade Name: Apatight-TCP Bone Graft Substitute Regulatory Class: unclassified Product Code: MQV Dated: March 21, 2002 Received: March 22, 2002

Dear Dr. Cassidy:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Antichensity of to de rioss 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 approvisions of the Act. The general controls provisions of the Act include controls providents or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wr ), it may of backed 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 mean that 127 man interes and regulations administered by other Federal agencies. or the Act of any I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instille (s 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.

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Page 2 - James J. Cassidy, Ph.D.

This letter will allow you to begin marketing your device as described in your Section The receiven will at the FDA finding of substantial equivalence of your device s ro(t) premainteted predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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Attachment 1

# INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K013966

Device Name: Apatight™-TCP Bone Graft Substitute

#### Indications for Use:

Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Division of General, Restorative and Neurological Devices

510(k) Number: K013966