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 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 adds an attachable applicator tip to the NovaBone Putty pre-filled cartridge delivery system (MIS delivery system). The tip provides for more precise control of NovaBone Putty placement.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "NovaBone Putty - Bioactive Synthetic Bone Graft." It outlines the device, its indications for use, technological characteristics, and a summary of performance testing.

However, the document explicitly states: "Human clinical testing was not conducted or relied upon for determining substantial equivalence for this premarket notification."

This means that the provided document does not contain any information about a study that proves the device meets specific acceptance criteria based on human performance data, clinical outcomes, or expert assessments. The clearance for this device was based on demonstrating substantial equivalence to a predicate device through non-clinical performance evaluations (cytotoxicity, bioburden, and bench tests for mechanical integrity).

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the specific points you raised (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth). The information necessary to answer those questions is not present in the provided text.

Summary

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February 5, 2024

NovaBone Products, LLC % David Gaisser Consultant Geyser Medical Consulting 10205 SW 2nd Place Gainesville, Florida 32607

Re: K240404

Trade/Device Name: NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6615) Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 9, 2024 Received: February 9, 2024

Dear David 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 (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.

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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.

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-regulatoryassistance/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).

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Sincerely, Jesse Muir -Digitally signed by Jesse Muir -S
Date: 2024.03.05
10:00:37 -05'00' S 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

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240404

Device Name

NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6615)

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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:

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Image /page/4/Picture/1 description: The image shows the logo for "NOVABONE". The logo is written in a sans-serif font, with the letters in teal and blue. The "O" in "NOVABONE" is stylized with a starburst pattern in the center. There is a registered trademark symbol in the upper right corner of the logo.

510(k) Summarv

Date:	February 09, 2024
Applicant:	Ed Horton, VP – Regulatory/QualityNovaBone Products, LLC13510 NW US Hwy 441Alachua, FL 32615Telephone: 386-462-7660Email: ehorton@novabone.com
Correspondent:	David M. GaisserGeyser Medical Consulting10205 SW 2nd PlaceGainesville, FL 32607Telephone: 352-332-7110E-Mail: dmgaisser@gmail.com
Type of Submission:Device Name:Common Name:Regulation:	Special 510(k)NovaBone Putty – Bioactive Synthetic Bone GraftBone Void Filler21 CFR 888.3045 – Resorbable Calcium Salt Bone Void Filler
Classification:Product Code:Review Panel:	Class IIMQVOrthopedic
Primary Predicate:Additional Predicate:	NovaBone Putty – Bioactive Synthetic Graft [K112773]NovaBone Putty [K060728, K080009, K082672, K101860,K110368]

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.

Device Description:

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binder are provided premixed as a pliable cohesive material. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass 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.

Technological Characteristics and Substantial Equivalence

The technological characteristics of the NovaBone Putty device are identical to the NovaBone Putty device cleared per K060728, K080009, K082672, K101860, K110368, and K112773. The 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 indications are the same as for the predicate. The device is intended to be used alone, or in combination with autogenous bone.

The subject and K112773 predicate are identical in materials and device characteristics. The NovaBone Putty device of this submission has been modified from that of the predicate solely in terms of the addition of an applicator tip to the device package; the device material itself and the MIS delivery system are unchanged. The device packaging in predicate K112773 consists of pre-filled polypropylene cartridges, which are attached to a delivery handle. The cartridges serve as a cannula to direct material placement. The applicator tip of the subject device can be used to refine device placement. The device action as a synthetic, inorganic, biocompatible, and osteoconductive scaffold into which new bone will grow is unchanged.

Performance Testing Summary:

Nonclinical evaluations of the modified device were performed to demonstrate equivalence to the predicate device. These tests included:

· Cytotoxicity testing per ISO 10993-5
· Bioburden evaluation per ISO 11137-1
· Bench tests for verification of system mechanical integrity

Clinical Data

Human clinical testing was not conducted or relied upon for determining substantial equivalence for this premarket notification.

Substantial Equivalence:

The NovaBone Putty device of this submission has the same design, materials, mode of action, manufacturing and sterilization processes, and technological characteristics as the predicate device. The design modification to include a new MIS applicator tip component does not result in a change in device intended use or raise new questions regarding device safety or effectiveness. The NovaBone Putty of this submission is substantially equivalent to the predicate device.

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.