OSSATURA BCP BONE VOID FILLER

K030131 · Isotis NV · MQV · May 20, 2003 · Orthopedic

Device Facts

• Record ID: K030131
• Device Name: OSSATURA BCP BONE VOID FILLER
• Applicant: Isotis NV
• Product Code: MQV · Orthopedic
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Story

OsSatura™ BCP is a synthetic, osteoconductive bone void filler composed of a biphasic ceramic scaffold (hydroxyapatite/tri-calcium phosphate). The device features an interconnected, open porous structure mimicking human cancellous bone and is supplied as irregular-shaped chips. It is used by surgeons in orthopedic procedures to fill surgically created or trauma-induced osseous defects that are not intrinsic to bony stability. The material is packed gently into the void, where it acts as a scaffold for new bone ingrowth and is gradually resorbed and replaced by natural bone during the healing process.

Clinical Evidence

No clinical data provided. Evidence consists of pre-clinical animal studies demonstrating support for bone ingrowth and device resorption, alongside biocompatibility testing and established clinical history of hydroxyapatite and tri-calcium phosphate materials.

Technological Characteristics

Biphasic ceramic scaffold (hydroxyapatite/tri-calcium phosphate). Materials meet ASTM F1185-88 and F1088-87. Interconnected, open porous structure. Supplied sterile and non-pyrogenic for single patient use.

Indications for Use

Indicated for orthopedic patients requiring filler for non-structural bony voids or gaps in the skeletal system (extremities, spine, pelvis) resulting from surgery or 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 (K994337)
• Pro Osteon® 500(R) Resorbable Bone void filler (K980817)

Submission Summary (Full Text)

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K030131

# 510(k) Summary for IsoTis NV OsSatura™ BCP Bone Void Filler

#### 1. SPONSOR

IsoTis NV Prof. Bronkhorstlaan 10 3723 MB Bilthoven The Netherlands

| Contact Person: | E. Schutte |
|-----------------|--------------------|
| Telephone: | [phone] |
| Facsimile: | [phone] |

Date Prepared: April 4, 2003

#### 2. DEVICE NAME

| Proprietary Name: | OsSatura TM BCP |
|----------------------|---------------------------------|
| Common/Usual Name: | Bone void filler |
| Classification Name: | Bone void filler (Unclassified) |

#### 3. PREDICATE DEVICES

Vitoss™ scaffold Synthetic Cancellous Bone void filler(K994337) Pro Osteon® 500(R) Resorbable Bone void filler (K980817)

#### DEVICE DESCRIPTION 4.

OsSatura™ BCP is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g., hydroxyapatite/tri-calcium phosphate) scaffold. The interconnected and open porous structure of OsSatura™ BCP is similar in structure to human cancellous bone. OsSatura™ BCP is available as irregular-shaped chips of different sizes.

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## 5. INTENDED USE

OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The OsSatura™ BCP and the predicate devices are all similar in design, materials of construction, and function. The OsSatura™ BCP product and the predicate devices are all made of calcium salts. The proposed and predicate devices are osteoconductive. The OsSatura™ BCP product and all the predicate devices provide an interconnected, porous scaffold and an environment for new bone ingrowth. All of the devices are provided sterile and non-pyrogenic for single patient use. The only difference between the proposed device and the predicate devices is that they are composed of different forms of calcium phosphate salts. These minor differences do not affect safety or effectiveness since they are all resorbable and carry out the same function. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for hydroxyapatite and tricalcium phosphate products support the safe use of OsSatura™ BCP. The hydroxyapatite and tri-calcium phosphate in the OsSatura™ BCP meet the requirements in ASTM F1185-88 and F1088-87. Additionally, testing performed on the proposed device confirmed that OsSatura™ BCP meets the applicable requirements of the FDA guidance documents on bone void fillers.

# 7. TESTING

Pre-clinical animal data demonstrate that OsSatura™ BCP chips support bone ingrowth into a variety of bony defects. Biocompatibility, extensive bench and animal testing using OsSatura™ BCP have been successfully performed to confirm that the device is degraded and resorbed over time and allows bone ingrowth.

Calcium-based ceramic materials, including hydroxyapatite and tri-calcium phosphate, have been used in clinical practice for more than 25 years with no remarkable safety issues. The devices to which OsSatura™ BCP claims substantial equivalence, Pro Osteon 500(R) and Vitoss scaffold, have been used safely for many years in the clinical environment.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

MAY 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IsoTis NV c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K030131

Trade/Device Name: OsSatura™ BCP (Bi-Calcium Phosphate) Bone Void Filler Regulatory Class: Unclassified Product Code: MQV Dated: April 9, 2003 Received: April 10, 2003

Dear Ms. McNamara-Cullinane:

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 - Ms. Mary McNamara-Cullinane, 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/dsma/dsmamain.html

Sincerely yours,

Mark A Milliken

Celia M. Witten, Ph.D., M.D 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): K030131

Device Name: OsSatura™ BCP Bone Void Filler

Indications for Use:

OsSatura™ BCP (Biphasic Calcium Phosphate) is bone void filler intended only for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OsSatura™ BCP is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced by bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mash A. Milken

Division of General, Restorative and Neurological Devices

510(k) Number K030131

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR

(Per 21 CFR 801.109)

OsSatura™ BCP Bone Void Filler Additional Information - K030131 April 4, 2003 Appendix C . Page 1 of 1