APATIGHT HA-BONE GRAFT SUBSTITUTE

K013960 · Cerabio, LLC · MQV · May 23, 2002 · Orthopedic

Device Facts

• Record ID: K013960
• Device Name: APATIGHT HA-BONE GRAFT SUBSTITUTE
• Applicant: Cerabio, LLC
• Product Code: MQV · Orthopedic
• Decision Date: May 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA 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-HA is a porous hydroxyapatite bone graft substitute; designed for repair of bony defects. Device features trabecular structure mimicking human cancellous bone; provides osteoconductive scaffold for bone regeneration. Supplied in block and granular forms; sterile. Implanted by surgeons into bony voids or gaps; placed in direct contact with viable host bone. Functions by guiding three-dimensional bone growth into interconnected pores; material resorbs and is replaced by new bone during healing. Benefits patient by facilitating bone repair in non-load-bearing skeletal defects.

Clinical Evidence

Animal model performance testing; demonstrated device was well-tolerated and completely integrated into defect sites. Interconnected porosity was completely filled with new bone at follow-up; no signs of inflammation or infection observed.

Technological Characteristics

Hydroxyapatite bone graft substitute; porous trabecular structure. Material satisfies ASTM standards for implantable hydroxyapatite. Supplied sterile in block and granular forms.

Indications for Use

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

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

• Pro Osteon 500R Resorbable Bone Graft Substitute (K990131, K980817)

Submission Summary (Full Text)

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K013960

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

## 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™-HA Bone Graft Substitute |
|---------------------|-----------------------------------------------------------------------------------------|
| Common / Usual Name | Bone Void Filler, Bone Graft Substitute |
| Classification Name | Filler, Calcium Sulfate Preformed Pellets |
| Equivalent Devices | Pro Osteon 500R Resorbable Bone Graft Substitute (Interpore Cross,<br>K990131, K980817) |

#### Device Description

Apatight-HA Bone Graft Substitute is a porous hydroxyapatite 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-HA Bone Graft Substitute guides the threedimensional regeneration of bone in the defect site into which it is implanted. When Apatight-HA Bone Graft Substitute is placed in direct contact with viable host bone, new bone grows in apposition to the surfaces of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.

#### Intended Use / Indications

Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA 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-HA was shown by analysis of available information to be identical in intended use and equivalent in materials and configuration to the predicate device. The material also satisfies an ASTM standard for implantable hydroxyapatite. 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-HA 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-HA treated animal. The information presented demonstrated that the Apatight-HA 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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850.

# MAY 2 3 2002

James J. Cassidy, Ph.D. President CERAbio, LLC Technology Center N4660 116510 St. Prescott, Wisconsin 54021-7644

Re: K013960

Trade Name: Apatight-HA 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 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 approvisions 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.

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 m 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); good manufacturing practice and noung (2) 00 regulation the quality systems (QS) regulation (21 CFR Part 820); and if roquirelies as bettronic 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 vours.

L. Mach A. Melleman

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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## INDICATIONS FOR USE STATEMENT

Page 1 of 1

4013960 510(k) Number (if known):

Apatight™ - HA Bone Graft Substitute Device Name:

#### Indications for Use:

Apatight-HA Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-HA 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)

for Mark A. Millam
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K013960