OPTIUM DBM GEL AND PUTTY

K053098 · Lifenet · MBP · Nov 28, 2005 · Orthopedic

Device Facts

• Record ID: K053098
• Device Name: OPTIUM DBM GEL AND PUTTY
• Applicant: Lifenet
• Product Code: MBP · Orthopedic
• Decision Date: Nov 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Optium DBM™ Gel and Putty are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone void filler that remodels into the recipient's skeletal system.

Device Story

Optium DBM Gel and Putty are bone void fillers composed of human demineralized cortical bone and USP grade glycerol. Used by surgeons to fill osseous defects in the extremities, spine, and pelvis that do not compromise structural stability. The device acts as a scaffold that remodels into the recipient's skeletal system. It is supplied sterile for surgical application. Clinical benefit is derived from its osteoinductive potential, facilitating bone repair in non-load-bearing gaps.

Clinical Evidence

No human clinical trials presented. Evidence consists of bench testing and an in vivo athymic mouse assay for osteoinductive potential. Quantitative histomorphometric analysis of explanted samples showed new bone formation equal to or greater than predicate devices. Biocompatibility testing performed per ISO 10993 standards, including genotoxicity, cytotoxicity, sensitization, irritation, systemic toxicity, and hemolysis.

Technological Characteristics

Composition: Human demineralized cortical bone and USP grade glycerol. Forms: Gel and Putty. Sterilization: Sterile. Biocompatibility: Tested per ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation), ISO 10993-11 (systemic toxicity), and ISO 10993-4 (hemolysis).

Indications for Use

Indicated for patients with bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Defects may be surgically created or traumatic in origin. Contraindications not specified.

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

• Allomatrix® Putty (K020895, K041168)
• Osteofil® (K043420)
• Exactech Resorbable Bone Paste (K020078)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for LifeNet. The logo consists of a blue and yellow circular emblem with a stylized figure inside, followed by the word "LifeNet" in blue, with a registered trademark symbol next to it. The text is in a serif font and appears to be the main identifier for the brand.

5809 Ward Court Virginia Beach, VA 23455
Tel: [phone] Fax: [phone]
www.lifenet.org

# 510(k) SUMMARY [As Required by 21 CFR 807.92(c)]

| Submitter's Name & Address: | LifeNet<br>5809 Ward Court<br>Virginia Beach, VA 23455 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David Klementowski<br>Tel: 757- 609 - 4495<br>Fax: 757- 464 - 5721<br>E-mail: [e-mail] |
| Date Summary Prepared: | October 31, 2005 |
| Device Name: | Trade/Proprietary Name – Optium DBM™ Gel<br>Optium DBM™ Putty<br>Common/Usual Name – Bone Void Filler,<br>Bone Graft<br>Substitute<br>Classification Name - Resorbable calcium salt<br>bone void filler device<br>(21 CFR 888.3045) |
| | Predicate Devices - The current devices share<br>some or all of the same<br>characteristics- intended use<br>product technical<br>characteristics and<br>performance characteristics<br>as described below for<br>Allomatrix® Putty (K020895<br>K041168), Osteofil® various<br>forms (K043420) and<br>Exactech Resorbable Bone<br>Paste (K020078) |

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Image /page/1/Picture/0 description: The image shows the LifeNet logo. The logo consists of a blue and yellow circular emblem on the left, featuring a stylized human figure within a circular arrow. To the right of the emblem is the word "LifeNet" in a bold, blue font. A small registered trademark symbol is located at the upper right of the word "LifeNet".

5809 Ward Court
Virginia Beach, VA 23455
Tel: [phone]
Fax: [phone]
www.lifenet.org

## 510(k) SUMMARY [As Required by 21 CFR 807.92(c)]

### Device Description:

These devices are comprised of sterile USP grade glycerol/glycerin and combined with human demineralized cortical bone at the point of manufacture.

### Intended Use:

Optium DBM™ Gel and Putty are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone void filler that remodels into the recipient's skeletal system.

### Technological Characteristics:

Optium DBM™ Gel and Putty and one or more of its predicate devices are comprised of similar components, such as a non-tissue derived excipient to improve the handling characteristics of the demineralized bone matrix (DBM). The glycerol excipient is resorbable like the PEG excipient in the Exactech Resorbable paste (K020078). Optium DBM™ Gel and Putty and all its predicate devices contain human DBM. Optium DBM™ Gel and Putty and all of its predicate devices have the same intended use as a bone void filler. Optium DBM™ Gel and Putty and all of its its predicate devices are available culture negative/sterile and in multiple forms (gels, pastes and/or putties). The differences between Optium DBM™ Gel and Putty and their predicate devices do not raise new questions of safety or efficacy.

### Non-Clinical Performance Data Supporting Substantial Equivalence Determination:

Optium DBM ™ Gel and Putty and at least one of its predicate devices were compared in an in vivo assay" for new bone formation. Results from these studies indicate that Optium DBM ™ Gel and Putty products had equal to or more new bone formation than the predicate device(s) assessed and therefore can be used as a

¹ Product was screened for osteoinductive potential in the athymic mouse assay. Findings from an animal based model are not necessarily predictive of human clinical results.

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Image /page/2/Picture/0 description: The image shows the LifeNet logo. The logo consists of a circular emblem on the left and the word "LifeNet" in blue text on the right. The emblem features a stylized human figure inside a circle with arrows, suggesting a cycle or network. The word "LifeNet" is written in a clear, bold font, with a registered trademark symbol next to it.

5809 Ward Court
Virginia Beach, VA 23455
Tel: [phone]
Fax: [phone]
www.lifenet.org

## 510(k) SUMMARY [As Required by 21 CFR 807.92(c)]

bone void filler with equivalent or better bone formation when compared to the predicate device. New bone formation was evaluated by quantitative histomorphometric analysis of the explanted samples.

Non-clinical Tests: (The following tests were conducted.)

Genotoxicity (Ref. ISO 10993-3)

- Bacterial Mutagenicity Assay (Ames) .
- In Vivo Mouse Micronucleus Assay .
- In Vitro Chromosomal Aberration Induction in Human Lymphocytes .

Cytotoxicity (Ref. ISO 10993-5)

- MEM Elution (Product and packaging performed according to USP) .
Sensitization (Ref. ISO 10993-10)

- ISO Guinea Pig Maximization Sensitization Test (Gel and Glycerol) .
Irritation (Ref. ISO 10993-10)

- ISO Intracutaneous Reactivity Test .
Systemic Toxicity (Ref. ISO 10993-11)

- ISO Acute Systemic Iniection Test .
- . ISO Subacute (28-Day) Subcutaneous Study

Hemolysis (Ref. ISO 10993-4)

- ·
#### Clinical Safety - History of Glycerol Containing Bone Void Fillers

This type of product has been on the U.S. market since 1991. Optium DBM™ Gel and Putty have been on the U.S. Market since May 2003. The Weinberg Group has analyzed data generated from clinical trials evaluating glycerol containing bone void fillers in multiple orthopedic, spinal, and dental applications. The results show a history of such products being used safely to treat these applications. Reference Section 20 of this 510(k) submission for more details.

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Image /page/3/Picture/0 description: The image shows the LifeNet logo. The logo consists of a circular emblem on the left and the word "LifeNet" in blue text on the right. The emblem features a stylized human figure inside a circle with arrows, suggesting a cycle or network. The word "LifeNet" is written in a clear, bold font, with a registered trademark symbol next to it.

5809 Ward Court Virginia Beach, VA 23455 Tel: [phone] Fax: [phone] www.lifenet.org

# 510(k) SUMMARY [As Required by 21 CFR 807.92(c)]

### Summary:

Based on the results of the non-clinical tests conducted, both the Optium DBM™ Gel and Putty have demonstrated that they are as safe, as effective, and perform as well as or better than the predicate devices noted.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is in black and white.

NOV 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David Klementowski Director of Regulatory Affairs Life Net 5809 Ward Court Virginia Beach, Virginia 23455

Re: K053098 Trade/Device Name: Optium DBM™ Gel and Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MBP, MQV Dated: October 31, 2005 Received: November 3, 2005

Dear Mr. Klementowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becament of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) 70 ttg enactment date of the Medical Device Amendments, or to commores that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rios may not it it it it 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 I ou may, moreloro, manel of the Act include requirements for annual registration, listing of general oonly is provisions 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 it may be subject to back as a 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 I loase oc acrised that I Dr o an inte your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cuttar statutes and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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#### Page 2 -David Klementowski

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and my of substantial equivalence of your device of your device to a legally premation notification " = 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 If you debite 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson לוגר Acting 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):

Device Name: Optium DBMTM Gel and Putty

#### Indications For Use:

These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into the bony voids or gaps of the skeletal system (e.g., extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone void filler that remodels into the recipient's skeletal system.

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Office Only)

Division of General, Restorative, and Neurologica: Devices

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510(k) Number_K053098