BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER

K070864 · Biomet Osteobiologics · MQV · Jun 1, 2007 · Orthopedic

Device Facts

• Record ID: K070864
• Device Name: BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER
• Applicant: Biomet Osteobiologics
• Product Code: MQV · Orthopedic
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.

Device Story

BonePlast® QS is a sterile, dry calcium sulfate powder; mixed intra-operatively with sterile setting solution to create an injectable bone void filler. Used by surgeons in clinical settings for non-load bearing skeletal defects (extremities, spine, pelvis) and specifically for posterolateral spinal fusion. Material is biodegradable; resorbs in 8-12 weeks. Provides a scaffold for bone void filling; aids in managing osseous defects resulting from surgery or trauma.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical laboratory testing and comparison to predicate devices.

Technological Characteristics

Calcium sulfate bone void filler; supplied as dry powder for intra-operative mixing with sterile setting solution. Biodegradable, resorbable material. Non-load bearing application.

Indications for Use

Indicated for patients with surgically created or traumatic osseous defects in the skeletal system (extremities, spine, pelvis). Limited to non-load bearing voids not intrinsic to bone stability; restricted to posterolateral spinal fusion procedures.

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

• Calcigen™ S Bone Void Filler (K013790)
• MIIG III (K024336)

Submission Summary (Full Text)

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K070864

# JUN - 1 2007

## 510(K) SUMMARY

BonePlast® QS Calcium Sulfate Bone Void Filler

| Preparation Date: | May 16, 2007 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Applicant/Sponsor: | Biomet Osteobiologics<br>100 Interpace Parkway<br>Parsippany, NJ 07054<br>Establishment Registration Number: 1450662 |
| Contact Person: | Debra Bing<br>Director of Regulatory Affairs |
| Proprietary Name: | BonePlast® QS Calcium Sulfate Bone Void Filler |
| Common Name: | Injectable Bone Void Filler |
| Classification Name: | Filler, Bone Void, Calcium Compound (MQV/888.3045) |

#### Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

- Calcigen™ S Bone Void Filler K013790, June 11, 2002 (Biomet Orthopedics, Inc., Warsaw, IN)
- MIIG III K024336, March 04, 2003 (Wright Medical Technology, Inc., Arlington, TN)
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Device Description: BonePlast OS Bone void filler is a sterile calcium suffate powder, which is supplied dry. When mixed with sterile setting solution intra-operatively, it becomes an injectable filling material for use in non-load bearing procedures. The filler is biogradable and resorbs in approximately eight to twelve weeks, depending on the defect size, based on animal studies.

Intended Use: BonePlast® QS is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the stability of the bone structure (i.e., the extremities, spine, and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.

Summary of Technological The technological characteristics (materials, design sizes, and indications) are similar to or identical to that of the predicate devices to which substantial equivalence is claimed. The product is also identical in chemistry and formulation to the predicate device Calcigen™ S Bone Void Filler ( K013790).

Non-Clinical Testing: The information presented demonstrates that the BonePlast® OS Calcium Sulfate Bone Void Filler is substantially equivalent to currently marketed predicate devices. Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Osteobiologics % Palaniswamy Vijay, MPH, Ph.D. Manager, Applied Regulatory Technology Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581-0587

JUN - 1 2007

Re: K070864

Trade/Device Name: BonePlast® QS Calcium Sulfate Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: Class II Product Code: MQV Dated: May 16, 2007 Received: May 17, 2007

Dear Mr. Vijay:

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 - Mr. Palaniswamy Vijay

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 toll-free number [phone] or [phone] or on the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Melheisen

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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DIGEST

#### INDICATIONS FOR USE

510(k) Number (if known): K070864

### Device Name: BonePlast® QS Calcium Sulfate Bone Void Filler

Indications for Use:

BonePlast® QS Bone Void Filler is indicated to be injected into open voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BonePlast® QS Bone Void Filler is indicated only for bone voids or gaps that are not intrinsic to the bone structure (i.e., the extremities, spine and pelvis). The device is limited to be used in posterolateral spinal fusion procedures only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ NO . (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Milkerson

(Division Sign-C (Division Sign-Chi)
Division of General, Restorative,

510(k) Number

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