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, 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. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. 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 must not be used to gain screw purchase or to stabilize screw placement.

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 PET-G tray or in a disposable plastic 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.

AI/ML Overview

The provided document, K082672, describes a Special 510(k) submission for a device modification to NovaBone Putty – Bioactive Synthetic Bone Graft. This submission focuses on a change in packaging format (addition of a filled-syringe package) and explicitly states that this modification does not result in a change in the technological characteristics of the device. Therefore, the document does not contain details about acceptance criteria based on performance studies for the device itself, nor does it describe specific studies proving the device meets such criteria.

The submission relies on the substantial equivalence to predicate devices (K060728, K080009, and K041613) and the fact that the core bioactive material and its function remain unchanged. The "study" mentioned is animal testing that demonstrated the absorption of the material, but this appears to be part of the initial characterization of the bioactive glass rather than a performance study related to this specific device modification.

Therefore, many of the requested fields cannot be directly answered from the provided text as they pertain to performance studies that are not detailed in this specialized submission.

Here’s a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in this document. This Special 510(k) is for a packaging modification, not a change in performance criteria. The document asserts that "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects," implying it continues to meet the acceptance criteria established for its predicate devices, but these specific criteria are not detailed here.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "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."

Sample Size: Not specified for the animal testing.
Data Provenance: Animal testing (species not specified). Retrospective in the context of this specific 510(k) submission, as it refers to prior testing of the material.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document does not describe a clinical study or expert review panel for establishing ground truth for device performance in the context of this submission.

4. Adjudication Method

Not applicable. No clinical or expert review study is detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an imaging or diagnostic device that would typically undergo MRMC studies.

6. Standalone Performance (Algorithm Only without Human-in-the-loop performance)

Not applicable. This is a medical implant, not a software algorithm.

7. Type of Ground Truth Used

For the mentioned animal testing related to material absorption:

Ground Truth: Biological observation of material absorption and replacement with bone tissue in an animal model.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning or AI device.

Summary of available information related to the device modification:

The Special 510(k) submission K082672 is primarily focused on a packaging modification (adding a filled-syringe format) for the NovaBone Putty. The submission explicitly states:

"This device modification does not result in a change in technological characteristics of the device."
"NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects."

This indicates that the safety and effectiveness were established in prior submissions (K060728, K080009, K041613) for the predicate devices, and this specific submission does not introduce new performance studies or acceptance criteria for the device's function as a bone graft. The animal testing mentioned about material absorption ("majority of the material is absorbed within six months of implantation, with >98% of the material being absorbed by 12 months") serves as part of the foundational characterization of the bioactive glass material, rather than a performance study for this specific device modification.

Summary

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K082672

Image /page/0/Picture/1 description: The image shows the logo for "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS". The word "NOVABONE" is in large, bold letters. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in smaller letters.

DEC 0 9 2008

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

09/12/08

1. Submitter Information:

Name:	NovaBone Products, LLC
Address:	13709 Progress Boulevard, #33Alachua, FL 32615
Telephone:	(386) 462-7660
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

2. Name of Device:

Trade Name:	NovaBone Putty – Bioactive Synthetic Bone Graf
Common Name:	Osteoconductive Bone Void Filler
	Synthetic Resorbable Bone Graft Material
Regulation Number:	21 CFR 888.3045
Regulation Name:	Bone Void Filler

3. Legally Marketed Predicate Device:

Predicate #1:	NovaBone Putty - Bioactive Synthetic Graft[K060728, K080009]
Predicate #2:	NovaBone-AR - Resorbable Bone Graft Substitute[K041613]

4. Device Description

ક 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, 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. It does not possess sufficient mechanical strength to support load-bearing defects prior to

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Special 510(k): Design Modification NovaBone Products, LLC NovaBone Putty - Bioactive Synthetic Bone Graft

hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. 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 must not be used to gain screw purchase or to stabilize screw placement.

Technological Characteristics 6.

The technological characteristics of the NovaBone Putty device are identical to the NovaBone Putty device cleared per K060728 and K080009. 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 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. 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.

7. Warnings and Precautions

NovaBone Putty is not indicated for use in load-bearing applications. It should not be used for vertebroplasty or kyphoplasty procedures. NovaBone Putty is intended for use by clinicians familiar with bone grafting and internal/external fixation techniques. 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 must not be used to gain screw purchase or to stabilize screw placement.

NovaBone Putty is intended for manual application and is not intended for injection through a constrained opening or under high pressures. High-pressure injection of NovaBone Putty should not be conducted as it could result in device over-pressurization, which may lead to device extrusion beyond the intended application site or to embolization of fat or the device into the bloodstream.

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Confidential

Special 510(k): Design Modification NovaBone Products, LLC NovaBone Putty - Bioactive Synthetic Bone Graft

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

The NovaBone Putty device modification subject to this submission is to include a filled-syringe package format to augment the current tray-in-pouch format. This device modification does not result in a change in technological characteristics of the device. NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects.

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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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with flowing lines, representing the department's mission related to health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 9 2008

Novabone Products, LLC % Mr. David M. Glasser 13709 Progress Boulevard, #33 Alachua, Florida 32615

Re: K082672

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: MQV Dated: November 11, 2008 Received: November 12, 2008

Dear Mr. Glasser:

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. Glasser

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 (240) 276-0120. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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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Special 510(k): Design Modification NovaBone Products, LLC NovaBone Putty - Bioactive Synthetic Bone Graft Confidential

STATEMENT OF INDICATIONS FOR USE

K082672 510(k) Number (if known):

NovaBone Putty -- Bioactive Synthetic Bone Graft Device Name:

Indications For Use:

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)

Nil Rp Qal firmm

(Division Sign-Of Division of General. Restorative, and Neurological Devices

510(k) Number K082672
1-1

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
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.(b)
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.