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 intervertebral disc space). 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 process. When used in intervertebral disc space, NovaBone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

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 - Bioactive Synthetic Bone Graft 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 provided in a PETG tray, disposable plastic syringe, or a prefilled cartridge delivery system (MIS delivery system).

AI/ML Overview

The provided text is a 510(k) summary for the NovaBone Putty - Bioactive Synthetic Bone Graft. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new, innovative device that requires extensive clinical validation. Therefore, many of the requested elements for describing acceptance criteria and proving device performance through a study (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods) are not explicitly detailed in this type of regulatory submission.

However, based on the information provided, here's what can be inferred and stated regarding the device's acceptance criteria and the "study" (or rather, the justification for substantial equivalence):

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

The document doesn't provide a table of precise quantitative acceptance criteria in the format typically seen for a new device's efficacy or safety trial. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is essentially the claim that the NovaBone Putty exhibits functional characteristics similar to the predicate devices and meets general safety and efficacy requirements for this class of device.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Intended Use	Same intended use as predicate devices.
Indications for Use	Same specific indications for use in the intervertebral body spine as predicate devices. Expands previous indications to include intervertebral disc space.
Material Composition	Similar material composition to predicate. Differences are addressed by prior functional animal model performance.
Osteoconductivity	Designed as an osteoconductive space-filling material.
Resorption & Replacement	Slowly absorbed and replaced by new bone tissue during healing.
Safety & Effectiveness	Differences in technological characteristics do not raise different questions of safety and effectiveness. Supported by prior functional animal model performance and existing data for predicate/reference devices.
Sterility	Leveraged from previously cleared devices (K240404, K082672).
Shelf-life	Leveraged from previously cleared devices (K240404, K082672).
Endotoxin	Leveraged from previously cleared devices (K240404, K082672).
Pyrogenicity	Leveraged from previously cleared devices (K240404, K082672).
Biocompatibility	Leveraged from previously cleared devices (K240404, K082672).
Bench Performance	Leveraged from previously cleared devices (K240404, K082672), as recommended in FDA's Class II Special Controls Guidance Document.
Performance in Intervertebral Body Space	Supported by a robust analysis of bone grafting materials in prior posterolateral spine fusion studies.

2. Sample sized used for the test set and the data provenance:

The document does not describe a "test set" in the context of a prospective clinical trial with a defined sample size for the current submission. Instead, it relies on:

Prior functional animal model performance: This data provenance is mentioned to address differences in material composition. The specific sample size for this animal model is not provided.
Previously cleared devices (K240404, K082672): Data for sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and bench performance are leveraged from these reference devices. The original sample sizes for these tests are not provided in this summary.
Prior posterolateral spine fusion studies: Mentioned to support performance in the intervertebral body space. No specific sample size or provenance for these studies is given.

Given this is a 510(k) submission, the data is likely a combination of pre-clinical (animal) data, bench testing, and potentially existing clinical data from predicate or reference devices, rather than a new, large-scale prospective clinical study specifically for this submission. The provenance (country of origin, retrospective/prospective) is not detailed for these underlying studies.

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

This information is not provided. Since no new clinical "test set" requiring expert ground truth establishment is described for this submission, these details are absent. The FDA's review process inherently involves experts, but not in the context of establishing ground truth for a discrete test set for the device's performance in this document.

4. Adjudication method for the test set:

Not applicable, as no described new clinical test set requiring adjudication is presented in this document.

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. The NovaBone Putty is a medical implant (bone graft) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.

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

Not applicable. The NovaBone Putty is a medical implant, not an algorithm.

7. The type of ground truth used:

For this 510(k) submission, the "ground truth" for the device's substantial equivalence is established by regulatory standards and existing data on the predicate devices. The safety and effectiveness claims are based on:

Functional animal model performance data: This would typically involve histological analysis, biomechanical testing, and potentially imaging to assess bone regeneration.
Previous characterization, bench performance, and biocompatibility studies: These tests follow recognized standards and guidance documents (e.g., ISO standards for biocompatibility (pathology), ASTM standards for material properties (bench data)).
Clinical experience with predicate and reference devices: The FDA considers the established safety and efficacy profile of the legally marketed predicate device as part of the ground truth for substantial equivalence.

8. The sample size for the training set:

Not applicable. The NovaBone Putty is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2024

NovaBone Products, LLC % Scott Bruder Founder and CEO Bruder Consulting & Venture Group 268 Glen Place Franklin Lakes, New Jersey 07417

Re: K242299

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: Class II Product Code: MQV Dated: August 2, 2024 Received: August 2, 2024

Dear Scott Bruder:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, JESSE MUIR Digitally signed by
JESSE MUIR JESSE MUIR -S -5 Date: 2024.09.25 13:14:49 -04'00' Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K242299

Device Name

NovaBone Putty - Bioactive Synthetic Bone Graft

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/4/Picture/1 description: The image shows the word "NOVABONE" in large, bold letters. The first four letters, "NOVA", are in a teal color, while the last four letters, "BONE", are in a darker blue color. A small registered trademark symbol is located to the right of the word "BONE".

510(k) Summary

Submitter

Ed Horton VP - Regulatory/Quality NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615

Correspondent

Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group Scott(a)BruderConsulting.com 201.874.9701

Date Prepared

August 2, 2024

Device

Trade Name	NovaBone Putty – Bioactive Synthetic Bone Graft
Common Name	Bone void filler
Regulation	21 CFR 888.3045 Resorbable calcium salt bone void filler device
Classification	Class II
Product Code	MQV
Panel	Orthopedic
Predicates
Primary Predicate	Prosidyan - Fibergraft™ BG Putty (K222276)

Reference Devices

Secondary Predicate

NuVasive - Attrax Putty (K203714) NovaBone Putty - Bioactive Synthetic Bone Graft (K240404) NovaBone Putty - Bioactive Synthetic Bone Graft (K082672)

Device Description

{5}------------------------------------------------

Indications for Use Statement

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, pelvis, and intervertebral disc space). 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. When used in intervertebral disc space, NovaBone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

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.

Substantial Equivalence

This submission expands the device's indications for use to include use in the intervertebral disc space. The intended use is the same for subject and predicate devices, which are cleared for use in intervertebral disc space. There are differences in the device's material composition, but this does not raise different questions of safety and effectiveness. The effect of differences in material composition is addressed in the prior functional animal model performance.

This submission incorporates a minor change in technological characteristics of the NovaBone Putty composition used in the tray and syringe configurations; the NovaBone Putty MIS delivery system device is identical to K240404. The NovaBone Putty device is designed as an osteoconductive space-filling material to be gently packed into osseous defect sites and used as a non-structural scaffold for the body's natural healing and bone regeneration process. The device is intended to be used alone, or in combination with autogenous bone.

Performance

The subject devices have been previously cleared under K240404 and K082672. which serve as Reference Devices. These submissions are leveraged to support the device's sterility, shelf-life, endotoxin, pyrogenicity, biocompatibility, and characterizations/bench performance as recommended in FDA's Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices. The device's performance in the intervertebral body space was supported by a robust analysis of bone grafting materials in the prior posterolateral spine fusion studies.

Summarv

The subject device and predicates have the same intended use, and the same specific indications for use in the intervertebral body spine. Any differences in technological characteristics between the subject device and predicate do not raise different questions of safety and effectiveness. Based on the clinical analysis, the device is substantially equivalent to the predicates.

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.