OSTEOSET BVF KIT

K010532 · Wrightmedicaltechnologyinc · MQV · Oct 26, 2001 · Orthopedic

Device Facts

• Record ID: K010532
• Device Name: OSTEOSET BVF KIT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Oct 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure 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. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. The OSTEOSET® BVF Kit is provided sterile for single use only.

Device Story

OSTEOSET® BVF Kit is a bone void filler system consisting of surgical grade calcium sulfate powder and a saline mixing solution. Clinicians mix components to create a radiopaque paste that can be injected or molded into pellets. The material is packed into non-load bearing osseous defects in the extremities, spine, or pelvis. The paste cures in-situ to fill voids and may augment provisional hardware (e.g., K-wires) for temporary support of bone fragments. The material is biodegradable, resorbing in approximately 30-60 days, and is replaced by bone during the healing process. Used in surgical settings; intended for single-patient use.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by material composition and design similarity to the predicate device.

Technological Characteristics

Materials: 98.5% surgical grade calcium sulfate (CaSO4·1/2H2O) and 1.5% medical grade calcium stearate (molding aid), both conforming to USP/NF standards. Mixing solution: 0.9% sterile NaCl (USP/NF). Form factor: Kit includes premeasured powder and saline in glass vials with mixing tools. Principle: Biodegradable, radiopaque bone void filler that cures in-situ. Sterilization: Sterile for single use.

Indications for Use

Indicated for patients with non-load bearing open bone voids or gaps in the skeletal system (extremities, spine, pelvis) resulting from surgery or traumatic injury. May be used at infected sites. Not for structural support.

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

• Wright Plaster of Paris Bone Void Filler Kit

Submission Summary (Full Text)

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## OCT 2 6 2001

K010532

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe In accelance mark of 1990 and in conformance with 21 CRF 807, this information serves as a Medical De Freeb Act of Effectiveness for the Use of the OSTEOSET® BVF Kit.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------|
| Date: | February 22, 2001 |
| Contact Person: | Ehab M. Esmail<br>Manager of Regulatory Affairs<br>Phone: [phone] Fax: [phone] |
| Proprietary Name: | OSTEOSET® BVF Kit |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Unclassified |
| Device Product Code and Panel Code: | Orthopedics/87/MOV |

### DEVICE INFORMATION

#### INTENDED USES/ INDICATIONS A.

The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure 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. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

The OSTEOSET® BVF Kit is provided sterile for single use only.

#### DEVICE DESCRIPTION B.

OSTEOSET® BVF Kits consist of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to mix the components into a These products are provided sterile for single patient use. When mixed paste. according to directions, the OSTEOSET® BVF Kit produces biodegradable,

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K01 0532
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radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.

After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The paste/beads are used to fill bone voids and may be used at an infected site.

#### C. MATERIALS

The materials used for the OSTEOSET® BVF Kit are identical to the materials used for previously submitted Wright Plaster of Paris Bone Void Filler:

- The powder supplied in the kit is 98.5% surgical grade calcium sulfate (CaSO4 . . 1/2 H2O) in conformance with USP/NF Standards for calcium Sulfate, and 1.5% medical grade calcium stearate (stearic acid) in conformance with USP/NF standards for calcium stearate (used as a molding aid). The powder will be supplied premeasured in a glass vial.
- The saline is 0.9% sterile NaCl, USP/NF for irrigation. The saline will be supplied . premeasured in a glass vial.

#### D. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material composition, and design features of the OSTEOSET® paste cured in situ are substantially equivalent to the intended use, material composition, and design features of the previously submitted Wright Plaster of Paris Bone Void Filler Kit.

The safety and effectiveness of the OSTEOSET® BVF Kit with the expanded claims is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

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OCT 2 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ehab M. Esmail Manager of Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K010532

Trade/Device Name: OSTEOSET® BVF Kit Regulatory Class: unclassified Product Code: MQV Dated: July 27, 2001 Received: July 30, 2001

Dear Mr. Esmail:

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. Ehab M. Esmail

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 yours,

for Mark N. Millerson

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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K010532

# OSTEOSET® BVF Kit

### INDICATIONS STATEMENT

The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into The micenced id/gap to cure in-situ; or molded into solid pellets that are gently packed into open open bollo volu gap to var intrinsic to the stability of bony structure 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. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

The OSTEOSET® BVF Kit is provided sterile for single use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Prescription Use (Per21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

D. Mark A. Milleson

storative