INTERGRO DBM

K082793 · Biomet Spine · MQV · Apr 2, 2009 · Orthopedic

Device Facts

• Record ID: K082793
• Device Name: INTERGRO DBM
• Applicant: Biomet Spine
• Product Code: MQV · Orthopedic
• Decision Date: Apr 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InterGro DBM products (Putty, Paste, Plus) are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm2. The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

Device Story

InterGro DBM is a resorbable, osteoconductive, and osteoinductive bone graft substitute derived from human allograft demineralized cortical bone matrix (DBM). It is processed via granulation and lyophilization. Some versions incorporate calcium salt granules for radiopacity and structural strength. The DBM is suspended in a biocompatible, semi-viscous lipid carrier. Provided ready-to-use in putty, paste, or plus consistencies for single-patient application. Used by surgeons to fill bony voids or gaps in extremities, pelvis, spine, and craniofacial sites. The device resorbs over time, replaced by host bone during healing. Osteoinductive potential is verified in vitro via C2C12 myoblast alkaline phosphatase assay, correlated with athymic rat muscle implantation models. Viral inactivation of donor tissue is validated through a panel of representative viruses.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, viral inactivation validation, and animal model performance evaluation (radiographic and histological). Osteoinductive potential assessed via in vitro C2C12 bioassay (correlated with rat model, r=0.88, p<0.0005).

Technological Characteristics

Resorbable bone graft substitute; components: demineralized cortical bone matrix (DBM), semi-viscous lipid carrier, and optional calcium salt granules. Processing: aseptic, lyophilized. Standards: AATB, ASTM, and FDA guidance documents used for material certification and performance testing.

Indications for Use

Indicated for patients requiring bone void filling in extremities, pelvis, and spine (posterolateral); autograft extender in spine; craniofacial defects/craniotomies ≤ 25cm². Applicable to surgically created or traumatic osseous defects.

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

• DynaGraft II
• DBX
• InterGro DBM

Submission Summary (Full Text)

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K082793

# APR – 2 2009

### 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

| Sponsor: | Biomet Spine/Biomet Trauma<br>100 Interpace Parkway<br>Parsippany NJ 07054 |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 2242816 |
| Manufacturing Site | Interpore Cross International<br>181 Technology Dr<br>Irvine CA 92618 |
| Manufacturing Site<br>Registration<br>Number: | 2029012 |
| Contact: | Kathleen Ideo<br>Regulatory Associate<br>Interpore Cross International<br>181 Technology Dr<br>Irvine CA 92618<br>[phone] |
| Date Prepared: | February 17, 2009 |
| Trade/Proprietary Name: | InterGro DBM (Putty, Paste, Plus) |
| Common/Usual Name: | DBM Bone Graft Substitute |
| Classification Name: | Bone Grafting Material |
| Device Classification: | Class II |
| Regulation Number | 21 CFR 888.3045 |
| Product Codes | MQV, MBP, GXP |
| Predicate Device: | DynaGraft II, DBX, InterGro DBM |
| Device Formulation: | InterGro DBM (Putty, Paste, Plus) |
| Performance: | Performance<br>standards<br>applicable<br>DBM-based<br>to |

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products have not been published by the FDA. Interpore Cross International intends to manufacture and package this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present. Voluntary performance standards, such as materials certifications, in-house SOP's, FDA Guidance Documents, AATB Standards and/or ASTM Standards are used as appropriate.

InterGro DBM is a resorbable, osteoconductive, and Device Description: osteoinductive bone graft substitute that resorbs and is replaced with bone during the healing process. Its main component, demineralized cortical bone matrix (DBM), is derived from donor human tissue (allograft bone) and contains various growth factors including osteoinductive proteins. The DBM has been granulated, lyophilized and aseptically processed. In some versions of the product, calcium salt granules shall be incorporated to provide additional radiopacity, osteoconduction, and enhanced structural strength. The carrier for InterGro DBM is a resorbable, biocompatible, semi-viscous lipid. InterGro DBM is provided ready-to-use in various physical consistencies. It is packaged in various sizes by volume for single patient use.

> InterGro DBM products (Putty, Paste, Plus) are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm2. The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

Indications for Use:

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Substantial Equivalence Viral Inactivation Validation: The methods for processing the DBM contained in InterGro DBM were Information evaluated for their viral inactivation potential. A select panel of viruses representing various viral types, sizes, shapes, and genomes were evaluated. The viral inactivation testing demonstrated suitable viral inactivation potential of the processing methods for a wide range of potential human viruses.

> Osteoinductive Potential: Each lot of DBM incorporated into InterGro DBM is assayed for its osteoinductive potential. The assay measures the alkaline phosphatase production of a myoblast cell line (C2C12) in the presence of human DBM compared to positive and negative controls (osteoinductive index). Results of the assay have been correlated with results from implantation of DBM into athymic rat muscle, which demonstrated a correlation coefficient of 0.88 (p<0.0005) and accurately predicted the in vivo osteoinductivity in 20 donor lots. '

> The combination of DBM, the carrier and, in some formulations, ceramic granules has not been evaluated for osteoinductivity; therefore it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. Additionally, it is unknown how osteoinductivity of the DBM component, measured via the in-vitro "C2C12" bioassay will correlate with human clinical performance of InterGro DBM products.

> 1Han B. Tang B. and Nimni M. Quantitative and Sensitive in vitro Assay for Osteoinductive Activity of Demineralized Bone Matrix. J Ortho Res, 2003, 21:648-54.

> Product Performance Testing: Performance of InterGro DBM was evaluated in an animal model by radiographic and histological methods.

> The safety and effectiveness of InterGro DBM is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification.

> InterGro DBM was found to be substantially equivalent to the predicate devices based on the intended use, base materials, select performance properties, and use of a handling material.

Conclusion: .

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Spine/Biomet Trauma % Ms. Kathleen Ideo 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K082793

Trade/Device Name: InterGro® DBM (Putty, Paste, Plus) Regulation Number: 21 CFR 888,3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, MBP, GXP Product March 25, 2009 Received: March 26, 2009

Dear Ms. Ideo:

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.

APR - 2 2009

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 (OS) 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. Kathleen Ideo

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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## Indications for Use

510(k) Number (if known): K082793

Device Name: InterGro® DBM (Putty, Paste, Plus)

Indications for Use:

InterGro DBM products (Putty, Paste, Plus) are to be used for filling bony voids or gaps in the extremities and pelvis that are not intrinsic to the bony stability of the structure, and as an autograft extender in the spine. InterGro Plus may also be used as a bone void filler in the spine (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. InterGro DBM may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterCro DBM products to be used should be based on the type of procedure and size of the graft site.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Hubert Dinhup
(Division Sign-Off) for MXH

Division of Gene Division
and Neurological Devices

510(k) Number K082793