OSTEOSET DBM PELLETS, MODEL 8600-48XX

K022828 · Wrightmedicaltechnologyinc · MQV · Apr 2, 2004 · Orthopedic

Device Facts

• Record ID: K022828
• Device Name: OSTEOSET DBM PELLETS, MODEL 8600-48XX
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Device Story

OSTEOSET® DBM Pellets are preformed, radiopaque, biodegradable bone void fillers composed of surgical-grade calcium sulfate, human demineralized bone matrix (DBM), and stearic acid. Supplied as 3.0 mm or 4.8 mm pellets for single-patient use. Intended for surgical implantation to fill non-structural osseous defects in extremities, spine, and pelvis. Pellets are packed into the defect site by a surgeon; they resorb in approximately 30-60 days. Device provides a scaffold for bone healing. Benefits include filling voids to support bone repair in non-load-bearing applications.

Clinical Evidence

No human clinical trials provided. Evidence includes in vitro bioassay of DBM osteoinductivity (Saos cell proliferation) and viral inactivation validation. Product performance compared to predicate in a canine model, showing equivalent radiographic, mechanical, and histological bone formation results.

Technological Characteristics

Materials: Surgical grade calcium sulfate, human DBM, stearic acid. Form factor: Preformed 3.0 mm or 4.8 mm pellets. Properties: Radiopaque, biodegradable (resorption 30-60 days). Sterilization: Sterile for single use.

Indications for Use

Indicated for patients with non-structural bony voids or gaps 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.

Submission Summary (Full Text)

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K'022828

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of OSTEOSET® DBM Pellets.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|------------------------------------------------------------------|
| Date: | February 16, 2004 |
| Contact Person: | Roger D. Brown<br>Sr. Director, Clinical and Regulatory Affairs |
| Proprietary Name: | OSTEOSET® DBM Pellets |
| Common Name: | Bone Void Filler |
| Classification Name and Reference: | Filler, Calcium Sulfate Preformed Pellets - Class II<br>888.3045 |
| Device Product Code and Panel Code: | Orthopedics/MOV |

# DEVICE INFORMATION

#### A. INTENDED USE

OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

#### B. DEVICE DESCRIPTION

OSTEOSET® DBM Pellets are made of surgical grade calcium sulfate incorporating Human Demineralized Bone Matrix (DBM) and stearic acid as a tableting aid. OSTEOSET® DBM Pellets are provided as preformed 3.0 mm or 4.8 mm pellets. The biodegradable, radiopaque pellets are used to fill bone voids and are resorbed in approximately 30-60 days when used according to labeling. This product is supplied sterile for single patient use.

#### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, materials, and mode of action of OSTEOSET® DBM Pellets are substantially equivalent to the predicate device. The safety and effectiveness of OSTEOSET® DBM Pellets is adequately supported by the substantial equivalence information, materials data, and testing results provided within this Premarket Notification.

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# DBM Osteoinductivity Potential Testing

The DBM incorporated into OSTEOSET® DBM Pellets is assayed in vitro for its osteoinductive potential. The bioassay measures the proliferation of Saos human osteosarcoma cells in the presence of human DBM compared to positive and negative controls (osteoinductivity index). Results from the bioassay were correlated with results from implantation of DBM into athymic rat muscle2, which demonstrated a correlation coefficient of 0.850 (p<0.0005)' and accurately predicted the in vivo osteoinductivity of 99 of 101 donor lots. Additionally, clinical results using DBM with >0.20 and ≤0.20 demonstrated a significant difference in healing as evaluated by radiography, 92% and 33% healing, respectively.3

- Adkisson HD. Strauss-Schoonberger J. Gillis M. Wilkins R. Jackson M. and Hruska KA. Rapid Quantitative 1 Bioassay of Osteoinduction, J Ortho Res, 2000, 18:503-511.
- 2 Lindholm TS, Urist MR. A quantitative analysis of new bone formation by induction in composite grafts of bone marrow and bone matrix, Clin Orthop 1980 Jul-Aug (150):288-300.
- 3 Wilkins RM, Clinical Effectiveness of Denineralized Bone Matrix Assayed in Human Cell Culture, Advances in Tissue Banking. 1999 3:113-124

The osteoinductivity of the OSTEOSET® DBM Pellets has not been established and it is unknown how osteoinductivity of the DBM component, measured via the in vitro bioassay, will correlate with human clinical performance of Osteoset DBM Pellets.

### Viral Inactivation Potential

The method for processing the DBM contained in OSTEOSET® DBM Pellets was evaluated for its viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing method for a wide spectrum of potential human viruses.

### Product Performance Testing

Performance of OSTEOSET® DBM Pellets was compared to the predicate device in a canine model by radiographic, mechanical, histological and quantification of new bone formation. There was no difference in radiographic, mechanical, histological and quantification of new bone formation at the end of the study.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2004

Roger D. Brown Director, Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K022828 Trade Name: OSTEOSET DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 6, 2004 Received: January 7, 2004

Dear Mr. Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 madc 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

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Page 2 - Mr. Roger D. Brown

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.

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 vours.

/ Mark H. 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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# INDICATIONS STATEMENT

510(K) Number (if known): K022828

OSTEOSET® DBM Pellets Device Name: ______________

Indications for Use:

OSTEOSET® DBM Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. OSTEOSET® DBM Pellets are intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Prescription Use X (Per21 CFR 801.109) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milburn

ral. Restorative, and Neurological Devices

510(k) Number K02

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