NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT

K101860 · Novabone Products, LLC · MQV · Sep 1, 2010 · Orthopedic

Device Facts

• Record ID: K101860
• Device Name: NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
• Applicant: Novabone Products, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Sep 1, 2010
• Decision: SESE
• Submission Type: Special
• 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, posterolateral spine, 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. NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Device Story

NovaBone Putty is an osteoconductive, bioactive synthetic bone void filler. It consists of calcium-phosphorus-sodium-silicate (Bioglass) particulate mixed with a synthetic binder. Supplied as a sterile, pliable, cohesive material in a disposable syringe with attachable cannula for delivery to defect sites. Used by surgeons to fill osseous defects; binder absorbs post-implantation to allow tissue infiltration; Bioglass particles act as a scaffold for new bone growth and are slowly resorbed. Device is non-structural; requires rigid stabilization via standard techniques. Modification in this submission involves updated syringe packaging to accommodate extension cannulas for improved access to remote graft sites.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and material composition to previously cleared predicates. Animal testing previously demonstrated that the majority of the material is absorbed within six months, with >98% absorption by 12 months.

Technological Characteristics

Composition: 45S5 Bioglass (calcium-phosphorus-sodium-silicate) particulate and synthetic binder. Form factor: Pliable, cohesive putty in a disposable syringe with extension cannula. Mechanism: Osteoconductive scaffold for bone ingrowth. Sterilization: Sterile.

Indications for Use

Indicated for patients with non-load-bearing bony voids or gaps in the skeletal system (extremities, posterolateral spine, pelvis) resulting from surgery or trauma. Contraindicated for load-bearing applications.

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 Putty - Bioactive Synthetic Graft (K060728)
• NovaBone Putty - Bioactive Synthetic Graft (K080009)
• NovaBone Putty - Bioactive Synthetic Graft (K082672)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The word "NOVABONE" is written in a bold, sans-serif font, with the letters "NOVA" in a distressed, textured style and the letters "BONE" in a solid, black style. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in a smaller, sans-serif font.

K101860

# Special 510(k): Device Modification Summary NovaBone Putty - Bioactive Synthetic Bone Graft

06/30/10

1- 2010

### Submitter Information: 1.

| Name: | NovaBone Products, LLC | SEF |
|------------|-----------------------------------------------------|-----|
| Address: | 13631 Progress Boulevard, #600<br>Alachua, FL 32615 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Contact: | David M. Gaisser | |

#### Name of Device: 2.

| Trade Name: | NovaBone Putty – Bioactive Synthetic Bone Graft |
|--------------------|------------------------------------------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler<br>Synthetic Resorbable Bone Graft Material |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Bone Void Filler |

#### Legally Marketed Predicate Device: 3.

NovaBone Putty - Bioactive Synthetic Graft Predicate #1: [K060728, K080009, K082672]

#### 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. The mixed device is supplied sterile, packaged in a disposable plastic syringe with one or more attachable cannula allowing for placement of the putty at a predetermined distance from the syringe. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles then are slowly absorbed and replaced by new bone tissue during the healing process.

#### Intended Use ડ.

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, posterolateral spine, 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.

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NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

#### 6. Technological Characteristics and Substantial Equivalence

The technological characteristics of the NovaBone Putty device are identical to the NovaBone Putty device cleared per K060728, K080009, and K082672. The device and predicate 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 predicate. The device is intended to be used alone, or in combination with autogenous bone.

The primary component of NovaBone Putty is bioactive glass (45S5 Bioglass) particulate. 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. Animal testing has demonstrated that the majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months. The timeframe for full absorption in humans has not been determined, but is expected to be at least 12 months.

The NovaBone Putty device of this submission has been modified from that of the predicate solely in terms of the device packaging; the device itself is unchanged. The previous syringe packaging has been modified to permit attachment of an extension cannula (included) to better access more remote graft sites. The device action as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow is unchanged.

#### 7. Conclusion

The NovaBone Putty device modification subject to this submission is to include a new syringe package format. The syringe applicator has been modified from that of prior devices to permit interfacing with a large-bore cannula. This device modification does not result in a change in technological characteristics of the NovaBone Putty device. NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects.

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Image /page/2/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 lines representing its wings and body. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NovaBone Products, LLC % Mr. David M. Gaisser 13631 Progress Boulevard, #600 Alachua, Florida 32615

SEP 1 2010

Re: K101860 ·

Trade/Device Name: NovaBone Putty - Bioactive Synthetic Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MOV Dated: July 29, 2010 Received: August 2, 2010

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. David M. Gaisser

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Sincerely, yours,

Barbara Buchner

Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101860

#### 1 2010 SEP STATEMENT OF INDICATIONS FOR USE

K101860 510(k) Number (if known):

Device Name: __________________ NovaBone Putty – Bioactive Synthetic Bone Graft

Indications For Use:

NovaBone Putty - Bioactive Synthetic Bone 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, posterolateral spine, 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.

NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

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)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101860