APACERAM BONE GRAFT SUBSTITUTE

K071912 · Pentax Corp. · MQV · Oct 29, 2007 · Orthopedic

Device Facts

• Record ID: K071912
• Device Name: APACERAM BONE GRAFT SUBSTITUTE
• Applicant: Pentax Corp.
• Product Code: MQV · Orthopedic
• Decision Date: Oct 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.

Device Story

Apaceram is a synthetic, porous hydroxyapatite bone void filler; provided in particulate and shaped forms (types AX, B, G, R). Device acts as an osteoconductive scaffold; placed into skeletal voids (extremities, spine, pelvis) by surgeons during procedures; supports new bone ingrowth; resorbed and replaced by host bone over time. Used as standalone filler or autograft extender. Benefits include structural support for non-load-bearing defects and promotion of natural bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence supported by biocompatibility testing and historical clinical use of hydroxyapatite materials.

Technological Characteristics

Synthetic hydroxyapatite; porous, interconnected scaffold structure; available in multiple shapes/sizes (AX, B, G, R); sterile; single-patient use.

Indications for Use

Indicated for patients requiring bone void filling in the skeletal system (extremities, spine, pelvis) due to degeneration, trauma, or surgery; used for defects not intrinsic to bony stability; can be used as autograft extender.

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

• ApaPore® Bone Graft Substitute (K033722)
• MBCP™ (K051774)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the text "K071912" at the top, followed by "Apaceram TM" and "Traditional 510(k)" below it. The text appears to be part of a document or label. The numbers "510" and "12" are clearly visible in the image.

## 510(k) SUMMARY— Apaceram™ Bone Void Filler

| Submitter Name: | Pentax Corporation |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 2-36-9 Maeno-cho |
| | Itabashi-ku, Todyo 174-8639 JAPAN |
| Contact Person: | Hiroyasu Takeuchi |
| | Vice President, General Manager |
| | New Ceramics Division |
| Phone Number: | 813-3960-1290 |
| Fax Number: | 813-3960-2681 |
| Date Prepared: | July 11, 2007 |
| Device Trade Name: | Apaceram ^™ Bone Graft Substitute |
| Device Common Name: | Synthetic, porous hydroxylapatite |
| Classification Number: | 21 CFR 888.3045 |
| Classification Name: | Resorbable calcium salt bone void filler |
| Product Code: | MQV |
| Predicate Devices: | K033722, ApaPore® Bone Graft Substitute, ApaTech Ltd. |
| | K051774, MBCP ^™ , Biomatlante. |
| Statement of Intended Use: | Apaceram ^™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ^™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram ^™ is resorbed and replaced with bone during the healing process. |
| Device Description: | Apaceram ^™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram ^™ is provided sterile for single patient use. |
| Technological Characteristics and Substantial Equivalence: | The Apaceram ^™ and the predicate devices are similar in design, material composition, final product configurations, and function. They are made of calcium salts, are osteoconductive, and provide an interconnected, highly porous scaffold environment for new bone ingrowth. The safety and biocompatibility testing performed by Pentax and a long history of safe clinical use of this material support the safety and effectiveness of Apaceram ^™ and its equivalence to the predicate devices. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pentax Corp. % Patsy J. Trisler, J.D., RAC Regulatory Consultant 5600 Wisconsin Avenue Suite 509 Chevy Chase, Maryland 20815

OCT 2 9 2007

Re: K071912

Trade/Device Name: Apaceram™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 11, 2007 Received: July 11, 2007

Dear Ms. Trisler:

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.

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 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); good manufacturing practice requirements 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 - Patsy J. Trisler, J.D., RAC

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Melhusen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name:

Apaceram™ Bone Graft Substitute

Indications for Use:

Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram ™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, spine, or pelvis) caused by degeneration, trauma or surgery. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Mark A. Millman

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number