BONESOURCE BVF

K031435 · Howmedica Osteonics · MQV · Aug 4, 2003 · Orthopedic

Device Facts

• Record ID: K031435
• Device Name: BONESOURCE BVF
• Applicant: Howmedica Osteonics
• Product Code: MQV · Orthopedic
• Decision Date: Aug 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected 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 with bone during the healing process.

Device Story

BoneSource® BVF is an injectable, self-setting, calcium phosphate cement used as a bone void filler. It is intended for non-structural bony defects in the extremities, spine, and pelvis caused by trauma or surgery. The material is biocompatible and bioresorbable, designed to be resorbed and replaced by natural bone during the healing process. It is applied by a clinician in a surgical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on material and device characteristics.

Technological Characteristics

Injectable, self-setting calcium phosphate cement. Biocompatible and bioresorbable material.

Indications for Use

Indicated for patients with non-structural bony voids or defects in the skeletal system, including extremities, spine, and 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

• BoneSource® HAC (K021440)
• Norian® SRS® Bone Void Filler (K011897)

Submission Summary (Full Text)

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## AUG - 4 2003

510(k) SUMMARY—BoneSource® BVF

| Submitter Name: | Howmedica Osteonics Corp. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 59 Route 17 Allendale, New Jersey 07401 |
| Contact Person: | Jennifer A. Daudelin, Regulatory Affairs Specialist |
| Phone Number: | 201-831-5379 |
| Fax Number: | 201-831-6038 |
| Date Prepared: | April 23, 2003 |
| Device Trade Name: | BoneSource® BVF |
| Device Common Name: | Hydroxyapatite Bone Void Filler |
| Classification Name and Number: | Filler, Calcium Sulfate Preformed Pellets 87 MQV |
| Predicate Device: | The BoneSource® BVF is substantially equivalent to the Stryker Instruments (Leibinger) BoneSource® HAC (K021440) and Synthes (USA) Norian® SRS® Bone Void Filler (K011897). |
| Device Description: | BoneSource® BVF is an injectable, self-setting, calcium phosphate cement that is biocompatible and bioresorbable. |
| Intended Use: | The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected 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 with bone during the healing process. |
| Conclusion: | This device, with respect to materials, device characteristics and intended use, is substantially equivalent to the predicate devices. |

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Image /page/1/Picture/2 description: The image is a black and white circular seal. The seal contains the words "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 an eagle with its wings spread, facing to the right. The eagle's body is formed by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2003

Ms. Debra Bing Manager, Regulatory Affairs Howmedica Osteonics Corporation 59 Route17 Allendale, New Jersey 07401-1677

Re: K031435

Trade/Device Name: BoneSource® BVF Regulatory Class: Unclassified Product Code: MQV Dated: May 5, 2003 Received: May 6, 2003

Dear Ms. Bing:

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. Iisting 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. Debra Bing

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,

Ella watts

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): K031435

Device Name:

BoneSource® BVF

## Indications for Use:

The BoneSource® BVF is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. The BoneSource® BVF is intended to be placed or injected 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 with bone during the healing process.

signature

eral. Restorative and Neurological De

510(k) Number K031435

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Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescription X Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)