NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT

K060728 · Novabone Products, LLC · MQV · May 1, 2006 · Orthopedic

Device Facts

• Record ID: K060728
• Device Name: NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
• Applicant: Novabone Products, LLC
• Product Code: MQV · Orthopedic
• Decision Date: May 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

NovaBone Putty is a synthetic, osteoconductive bone void filler. It consists of 45S5 bioactive glass (calcium-phosphorus-sodium-silicate) particulate combined with a synthetic binder. Provided as a premixed, pliable, cohesive material; intended for clinical use by surgeons familiar with bone grafting. The clinician packs the putty into non-structural osseous defects (extremities/pelvis). Post-implantation, the binder absorbs, allowing tissue infiltration between bioactive glass particles. The glass acts as a scaffold for new bone growth, gradually resorbing and being replaced by natural bone tissue. It provides no mechanical load-bearing support; requires standard internal/external fixation if stabilization is necessary. Benefits include facilitating natural bone regeneration in non-load-bearing gaps.

Clinical Evidence

In vivo performance data and supporting in vitro data were provided to demonstrate substantial equivalence. No specific clinical trial metrics (e.g., sensitivity, specificity) are reported; the device relies on established osteoconductive properties of bioactive glass.

Technological Characteristics

Osteoconductive bone void filler composed of 45S5 bioactive glass (calcium-phosphorus-sodium-silicate) particulate and a synthetic binder. Pliable, cohesive form factor. Non-structural, resorbable scaffold. Biocompatible materials. No electronic or mechanical components.

Indications for Use

Indicated for patients with non-structural bony voids or gaps in the skeletal system, specifically extremities and pelvis, resulting from surgical creation or traumatic injury. Contraindicated for load-bearing defects or where rigid stabilization is required.

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

• NovaBone -- Resorbable Bone Graft Substitute (K021336)
• Exactech Resorbable Bone Paste (K020078)
• Grafton DBM (K051195)

Submission Summary (Full Text)

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# 510(k) Summary NovaBone Putty - Bioactive Synthetic Graft

03/15/06

## 1. Submitter Information:

| Name: | NovaBone Products, LLC |
|------------|----------------------------------------------------|
| Address: | 13709 Progress Boulevard, #33<br>Alachua, FL 32615 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | David M. Gaisser |

### 2. Name of Device:

| Trade Name: | NovaBone Putty - Bioactive Synthetic Graft |
|----------------------|--------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler |
| | Synthetic Resorbable Bone Graft Material |
| Classification Name: | Unknown |

#### Legally Marketed Predicate Device: 3.

| Predicate #1: | NovaBone -- Resorbable Bone Graft Substitute - |
|---------------|------------------------------------------------|
| | [K021336] |
| Predicate #2: | Exactech Resorbable Bone Paste - [K020078] |
| Predicate #3: | Grafton DBM - [K051195] |

### 4. Device Description

NovaBone Putty is an osteoconductive, bioactive, bone void filler device. It is composed of a calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process.

### 5. Intended Use

NovaBone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and These defects may be surgically created osseous defects or osseous pelvis). defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

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### Technological Characteristics ర్.

The technological characteristics of the NovaBone Putty device are similar to those of the predicates. The device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as non-structural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the predicates.

The primary component of NovaBone Putty is identical to the bioactive glass (45S5 Bioglass) particulate found in the NovaBone predicate. This synthetic material is both biocompatible and osteoconductive. The NovaBone Putty includes a synthetic binder as an inert carrier for ease of handling and delivery, forming a premixed cohesive material. The binder is biocompatible and is absorbed after implantation, opening space between the bioactive glass particles for cell infiltration and bone formation. The bioactive glass particulate remains for a longer post-implantation period, acting as a scaffold for bone ingrowth. This particulate is absorbed and replaced by new bone tissue.

### 7. Warnings and Precautions

NovaBone Putty does not possess sufficient mechanical strength to support loadbearing defects prior to hard tissue ingrowth. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.

NovaBone Putty is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.

#### 8. Complications

Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery.

#### 9. Conclusion

NovaBone Putty is claimed to be substantially equivalent to the NovaBone. Exactech Resorbable Bone Paste, and Grafton DBM predicate devices as a nonstructural osteoconductive bone void filler for osseous defects. In vivo performance data were presented. Additional supporting in vitro data were supplied.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2006

NovaBone Products, LLC c/o Mr. David M. Gaisser VP, Operations/RA/QA 13709 Progress Boulevard #33 Alachua, Florida 32615

Re: K060728

Trade/Device Name: NovaBone Putty - BioActive Synthetic Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Bone Void Filler Regulatory Class: Class II Product Code: MQV Dated: March 15, 2006 Received: March 17, 2006

Dear Mr. Gaisser:

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. David M. Gaisser

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/industry/support/index.html.

Sincerely yours,

Hubert Lerner wo

for
L

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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# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _______________________________________ NovaBone Putty II - Bioactive Synthetic Graft

Indications For Use:

NovaBone Putty -- Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Prescription Use _ XX _

OR (Per 21 CFR 801.109) Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Lemer 10

Division of General, Restorative, and Neurological Devices

**510(k) Number** K060728