Who is the manufacturer of GlassBone Granules?

Noraker filed the 510(k) submission for GlassBone Granules (K242782).

What is the FDA product code for GlassBone Granules?

MQV. It is classified under 21 CFR 888.3045 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for GlassBone Granules?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GlassBone Granules?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GlassBone Granules

K242782 · Noraker · MQV · Dec 23, 2024 · Orthopedic

Device Facts

Record ID	K242782
Device Name	GlassBone Granules
Applicant	Noraker
Product Code	MQV · Orthopedic
Decision Date	Dec 23, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3045
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process.

Device Story

GlassBone Granules is a synthetic, biocompatible, osteoconductive bone void filler composed of 45S5 bioactive glass (SiO2, P2O5, CaO, Na2O). The device is supplied as amorphous, non-porous, random-shaped particles in various unit sizes. It is intended for surgical implantation to fill non-structural bony voids or gaps in the extremities and pelvis. Upon implantation, the granules leach ions that react with body fluids, chemically transforming the glass surface into a structure resembling the mineral phase of natural bone. This process facilitates bone replacement during healing. The device is for single-use, gamma-sterilized, and MR safe. It is used by surgeons in clinical settings to treat osseous defects in adults and pediatric patients (≥ 6 years).

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing (pH, solubility, apatite formation, heavy metals, crystallinity, particle size, surface area) and biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, implantation effects, genotoxicity).

Technological Characteristics

Material: 45S5 bioactive glass (SiO2, P2O5, CaO, Na2O). Form: Amorphous, non-porous, random-shaped particles. Sizes: 0.5-1mm and 1-3mm. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ASTM F1538, ISO 10993, ISO 11137, ISO 11607. Osteoconductive, MR safe.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) resulting from benign bone cysts, tumors, surgical creation, or traumatic injury in adults and pediatric patients ≥ 6 years old. Not for use in defects intrinsic to bony structure stability.

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

BonAlive Granules (K231528)

Reference Devices

NovaBone Resorbable Bone Graft Substitute (K052494)

Related Devices

K132805 — BG MORSELS · Prosidyan, Inc. · Mar 14, 2014
K231528 — Bonalive Orthopedics granules · Bonalive Biomaterials, Ltd. · Jul 11, 2023
K191274 — BonAlive Granules · Bonalive Biomaterials, Ltd. · Aug 7, 2019
K071199 — BONALIVE GRANULES · Vivoxid , Ltd. · Feb 1, 2008
K092541 — INTERFACE · Biostructures · Nov 9, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. December 23, 2024 Noraker % Elisa Maldonado-Holmertz RA/QA Consultant Obelix Consulting 806 Jefferson Street Bastrop, Texas 78602 Re: K242782 Trade/Device Name: GlassBone Granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: November 12, 2024 Received: November 13, 2024 Dear Ms. Maldonado-Holmertz: 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, Digitally signed by JESSE MUIR JESSE MUIR -S Date: 2024.12.23 09:42:12 -05'00 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 Submission Number (if known) K242782 Device Name GlassBone Granules #### Indications for Use (Describe) GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process. 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. 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}------------------------------------------------ # 510(k) SUMMARY #### SUBMITTER #### Submission Sponsor: Catherine FLACARD Compliance & Innovation Chief Officer Noraker, SAS 60, Avenue Rockefeller 69008 Lyon France Email: c.flacard@noraker.com Tel number: +33 (0)4 78 93 30 92 #### Submission Correspondent: Elisa Maldonado-Holmertz RA/QA Consultant Obelix Consulting, LLC 806 Jefferson St Bastrop, TX 78602 USA Email: elisamh@obelixconsult.com Tel number: +1 512 431 6069 #### Date Prepared: 13 September 2024 #### SUBJECT DEVICE Name of Device: GlassBone Granules Common or Usual Name: Filler, Bone Void, Calcium Compound Classification Name: Resorbable calcium salt bone void filler device (21 CFR 888.3045) Regulatory Class: Class II Product Code: MQV #### PREDICATE DEVICE BonAlive Granules - K231528 {5}------------------------------------------------ This predicate has not been subject to a design-related recall. #### REFERENCE DEVICE NovaBone Resorbable Bone Graft Substitute - K052494 This predicate has not been subject to a design-related recall. #### DEVICE DESCRIPTION GlassBone Granules is a synthetic and biocompatible bone substitute device (bioactive glass 4555). GlassBone Granules is composed by weight of 4555 bioactive glass granules (45% SiO2, 6% P2O5, 24.5% CaO and 24.5% Na2O). It is sterilized with gamma irradiation and is single use and is available in different unit sizes. #### INDICATIONS FOR USE GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process. Rx only. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE GlassBone Granules is substantially equivalent to the following predicate and reference device: | Manufacturer | Subject Device Noraker SAS | Primary predicate BonAlive Biomaterials, Ltd | Reference Device NovaBone | SIGNIFICANT DIFFERENCES | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Trade Name | GlassBone® Granules | BonAlive® Granules | Resorbable Bone Graft Substitute (Particulate) | None | | 510(k) Number | - | K231528 | K052494 | - | | Product Code | MQV | MQV | MQV | None | | Regulation Number | 888.3045 | 888.3045 | 888.3045 | None | | Regulation Name | Resorbable calcium salt bone void filler device | Resorbable calcium salt bone void filler device | Resorbable calcium salt bone void filler device | None | | Indications for Use | GlassBone Granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities | Bonalive® Orthopedics granules is an implant intended to fill bony voids or gaps of the skeletal system (i.e., | NovaBone Resorbable Bone graft substitute is indicated only for bony | None | | Manufacturer | Subject Device Noraker SAS | Primary predicate BonAlive Biomaterials, Ltd | Reference Device NovaBone | SIGNIFICANT DIFFERENCES | | Trade Name | GlassBone® Granules | BonAlive® Granules | Resorbable Bone Graft Substitute (Particulate) | None | | | and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. GlassBone Granules resorbs and is replaced with bone during the healing process. | extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process. | voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone 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. | | | Rx or OTC | Rx | Rx | Rx | None | | Physical Form | Amorphous, non-porous random- shaped particles | Amorphous, non-porous random- shaped particles | Amorphous, non-porous random- shaped particles | None | | Color | Brown | Brown | White | None | | Materials Composition | Bioactive glass 45S5 Bioglass (SiO₂, P₂O₅, CaO and Na₂O) | Bioactive glass S53P4 glass (SiO₂, P₂O₅, CaO and Na₂O) | Bioactive glass 45S5 Bioglass (SiO₂, P₂O₅, CaO and Na₂O) | None | | Product Sizes | Granule sizes: 0.5-1mm 1-3mm Product volumes: 0.5cc 1 cc 5 cc 10 cc 16 cc | Granule sizes: 0.5-0.8 mm 1.0-2.0 mm Product volumes: 1 cc 2.5 cc 5 cc 10 cc | Granule sizes: 90-710μm Product volumes: 2 cc 5 cc 10 cc 15 cc | Similar without affecting safety or effectiveness | | Biocompatibility | Biocompatible ISO 10993 | Biocompatible ISO 10993 | Biocompatible ISO 10993 | None | | Sterilization | Gamma, SAL 10⁻⁶ | Gamma, SAL 10⁻⁶ | EtO, SAL 10⁻⁶ | None | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | None | | Single Use/ Reuse | Single use only | Single use only | Single use only | None | | Mode of action | Works by leaching ions that react with the body fluids transforming the glass surface chemically into one that by its chemical composition and structure resembles the mineral phase found in natural bone. | Works by leaching ions that react with the body fluids transforming the glass surface chemically into one that by its chemical composition and structure resembles the mineral phase found in natural bone. | Works by leaching ions that react with the body fluids transforming the glass surface chemically into one that by its chemical composition and structure resembles the mineral phase found in natural bone. | None | | Manufacturer | Subject Device Noraker SAS | Primary predicate BonAlive Biomaterials, Ltd | Reference Device NovaBone | SIGNIFICANT DIFFERENCES | | Trade Name | GlassBone® Granules | BonAlive® Granules | Resorbable Bone Graft Substitute (Particulate) | None | | Properties | Synthetic Osteoconductive | Synthetic Osteoconductive | Synthetic Osteoconductive | None | | MR safety | MR Safe | MR Safe | Unknown | None | {6}------------------------------------------------ {7}------------------------------------------------ ### NON CLINICAL PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination: #### Bench testing: Bench testing was conducted according to FDA Guidance "Resorbable Calcium Salt Bone Void Filler Device - Class II Special Controls Guidance Document for Industry and FDA Staff" and ASTM F1538. - . pH - Solubility . - Apatite - Composition - Heavy Metals - Crystallinity - Particle Size - . Surface Area ### Animal testing and biocompatibility: Biocompatibility testing was conducted in accordance with ISO-10993-1, "Biological evaluation of medical device – Part 1: Evaluation and testing within a risk management process". - Physico-chemical characterization - Cytotoxicity - Sensitization - Irritation or intracutaneous reactivity - Material mediated pyrogenicity - Acute systemic toxicity - Local effects of implantation - Genotoxicity {8}------------------------------------------------ ## Sterility and Shelf Life The following testing was performed on GlassBone Granules: - ISO 11137 Radiation Sterilization Validation ● - ISO 11607 Packaging for terminally sterilized medical devices ● ## Clinical Performance Data There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. ## Statement of Substantial Equivalence Noraker GlassBone Granules is substantially equivalent to the predicate device when comparing the following characteristics: - •Indications for Use - •Principles of Use - •Fundamental Technology - •Basic Design - •Materials Used - •Where used - •Standards met - •Sterilization Method GlassBone Granules meet all requirements for overall design and confirms that the output meets the design inputs and specifications. The GlassBone Granules passed all testing stated above as shown by acceptable results obtained. GlassBone Granules complies with the applicable voluntary, national, and international standards and guidance. Noraker, SAS believes that the bench and non-clinical performance data supports the safety of GlassBone Granules, and the device should perform effectively as intended in the specified use conditions. The non-clinical performance data demonstrates that GlassBone Granules performs comparably to the predicate device that is currently marketed for the same intended use and presents no new concerns about safety and effectiveness.