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.

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 then are slowly absorbed and replaced by new bone tissue during the healing process. The mixed device is supplied sterile and is packaged in single-use containers in multiple formats.

The device modification of the current submission packages the device in prefilled cartridges that are interchangeably attached to a dispensing handle. The length of the cartridges provides direct access application of the Putty to more remote defect sites.

AI/ML Overview

This document is a 510(k) premarket notification for a modification to an existing medical device, NovaBone Putty. The modification specifically concerns the packaging (new pre-filled cartridges and dispensing handle) and not the material composition or intended use of the bone graft itself.

Therefore, the document does not contain information typically found in a study proving a device meets acceptance criteria related to its clinical efficacy or diagnostic performance. Instead, it demonstrates substantial equivalence to a predicate device based on material composition, intended use, and technological characteristics.

Here's an breakdown based on the provided text, addressing your questions where possible and indicating when the information is not present:

1. A table of acceptance criteria and the reported device performance

This document does not describe specific acceptance criteria and device performance metrics in the way one would for a new clinical or diagnostic device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device, which primarily relies on regulatory standards and comparison of attributes.

The core "performance" demonstrated is that the device modification (packaging) does not alter the fundamental characteristics or safety/effectiveness of the bone graft material itself.

Acceptance Criteria (Implicit from 510(k) process for device modification)	Reported Device Performance / Characteristics
No change in material composition.	The primary component of NovaBone Putty is bioactive glass (45S5 Bioglass) particulate, mixed with a synthetic binder. The device material itself is unchanged from the predicate.
No change in intended use.	Indicated only for bony voids or gaps not intrinsic to bony structure stability. To be gently packed into bony voids or gaps of the skeletal system (extremities, posterolateral spine, and pelvis) due to surgically created osseous defects or traumatic injury. Provides a bone void filler that resorbs and is replaced with bone during healing. Not for load-bearing applications. These indications are the same as for the predicate.
No change in fundamental technological characteristics.	Osteoconductive, bioactive, bone void filler. Acts as a non-structural scaffold for natural healing and bone regeneration. Synthetic, inorganic, biocompatible, and osteoconductive scaffold.
Packaging modification improves access to remote sites.	The new cartridge-handle format provides improved access to remote graft sites.
No new safety concerns introduced by modification.	(Implicitly demonstrated by submission approval, no new testing results in the document to detail this, but it's a fundamental aspect of the 510(k) process). The FDA's letter states that they have "determined the device is substantially equivalent... to legally marketed predicate devices."
Continued biocompatibility.	Binder and bioactive glass are biocompatible. (Animal testing mentioned for absorption, but not new biocompatibility results for this submission).
Resorption and bone replacement.	Resorbs and is replaced with bone during the healing process. Animal testing demonstrated majority absorbed within 6 months, >98% by 12 months. This is a property of the material, not newly tested for this specific packaging modification.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This submission is for a packaging modification, not a clinical study involving a "test set" of patients or data in the typical sense. The document refers to "animal testing" for absorption but does not provide sample sizes or explicit details of the study for this specific submission; it refers to properties of the existing material.
Data Provenance: Not applicable for a "test set" in this context. The "animal testing" referenced appears to be from previous submissions/data for the original material, not new data generated for this specific packaging modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No "ground truth" was established by experts for a clinical "test set" within this submission. The FDA's review process involves their own experts assessing the substantial equivalence.

4. Adjudication method for the test set

Not applicable. No "test set" or adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-based device or a diagnostic device that would undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth in the clinical study sense. The "truth" for this submission is established through comparison to the predicate device and demonstration that the modification does not change material properties or intended use, evaluated against regulatory standards.

8. The sample size for the training set

Not applicable. No training set as this is not an AI device or a device requiring a new clinical trial.

9. How the ground truth for the training set was established

Not applicable. No training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for NOVABONE. The logo is in black and consists of the word "NOVABONE" in large, bold letters. Below the word "NOVABONE" is the phrase "SYNTHETIC BONE GRAFT PRODUCTS" in smaller letters. The letter "O" in "NOVABONE" is stylized to look like a starburst.

OCT 1 4 201

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

09/22/11

Submitter Information: 1.

Name:	NovaBone Products, LLC
Address:	13631 Progress Boulevard, #600
	Alachua, FL 32615
Telephone:	(386) 462-7661
Facsimile:	(386) 418-1636
Contact:	David M. Gaisser

Name of Device: 2.

Trade Name:	NovaBone Putty – Bioactive Synthetic Bone Graft
Common Name:	Osteoconductive Bone Void FillerSynthetic 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, K082672, K101860, K110368]

4. Device Description

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, posterolateral spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product

{1}------------------------------------------------

K112773

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.

Technological Characteristics and Substantial Equivalence 6.

The technological characteristics of the NovaBone Putty device are identical to the NovaBone Putty device cleared per K060728, K080009, K082672, K101860, and K110368. The device is designed as an osteoconductive space-filling device to be gently packed into defect sites and used as a non-structural scaffold 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 material itself is unchanged. The device packaging in predicate K101860 consists of a pre-filled polypropylene syringe to which a supplied cannula is attached to extend access to more remote graft sites. The current submission consists of a long, pre-filled polypropylene cartridge, which is attached to a delivery handle, the cartridge serving the purpose of the cannula of the predicate submission. The device action as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow is unchanged.

7. Conclusion

The device modification of this submission is to include a new package format. The new cartridge-handle format provides improved access to remote graft sites. 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.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo with the words "HEALTH & HUMAN SERVICES" written around the edge. Inside the circle are three stylized human figures, represented by curved lines. The logo appears to be a seal or emblem, possibly representing a government agency or organization focused on health and human services.

For d and Drug Administration 16903 New Flampshire Avenue Document Control Koom -- W (966-G609 Silver Spring, MD 20993-0002

OCT 1 4 2011

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

Re: K112773

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: September 22, 2011 Received: September 23, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

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

{3}------------------------------------------------

Page 2 - Mr. David M. Gaisser

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.

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/MedicalDevices/Safetv/ReportalProblem/default.htm 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin Keith

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):	K11 2773
---------------------------	----------

Device Name:

Indications For Use:

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-Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112773

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.