Who is the manufacturer of Bonalive Orthopedics granules?

Bonalive Biomaterials, Ltd. filed the 510(k) submission for Bonalive Orthopedics granules (K231528).

What is the FDA product code for Bonalive Orthopedics 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 Bonalive Orthopedics granules?

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

Who can help prepare an FDA 510(k) submission like Bonalive Orthopedics 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.

Bonalive Orthopedics granules

K231528 · Bonalive Biomaterials, Ltd. · MQV · Jul 11, 2023 · Orthopedic

Device Facts

Record ID	K231528
Device Name	Bonalive Orthopedics granules
Applicant	Bonalive Biomaterials, Ltd.
Product Code	MQV · Orthopedic
Decision Date	Jul 11, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3045
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

Bonalive® Orthopedics 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. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process.

Device Story

Bonalive® Orthopedics granules is a sterile, synthetic, osteoconductive bone void filler composed of bioactive glass (SiO2, Na2O, CaO, P2O5). The device is implanted by a surgeon into bony voids or gaps in the extremities or pelvis. Upon contact with body fluids, the glass leaches ions and forms a silica-gel layer, which facilitates calcium phosphate precipitation and crystallization into hydroxyapatite. This process enables the material to bond chemically to living bone tissue. The granules are radiodense, allowing for postoperative radiologic evaluation, and are gradually resorbed and replaced by natural bone over time. The device is intended for single-use only.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by non-clinical performance data, including biocompatibility (ISO 10993), sterility validation (ISO 11137), and material characterization performed on the predicate device.

Technological Characteristics

Composition: Bioactive glass (SiO2, Na2O, CaO, P2O5). Form: Amorphous, non-porous, random-shaped granules (0.5-0.8 mm or 1.0-2.0 mm). Sterilization: Gamma irradiation (SAL 10^-6). Biocompatibility: ISO 10993 compliant. MR Safety: MR Safe.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) in adults and pediatric patients ≥ 6 years old. Defects may result from benign bone cysts, tumors, surgical creation, or traumatic injury. Not for use where structural stability is required.

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 (K191274)

Reference Devices

Pro-Dense Bone Graft Substitute (K113871)

Related Devices

K191274 — BonAlive Granules · Bonalive Biomaterials, Ltd. · Aug 7, 2019
K071199 — BONALIVE GRANULES · Vivoxid , Ltd. · Feb 1, 2008
K242782 — GlassBone Granules · Noraker · Dec 23, 2024
K070055 — BONALIVE GRANULES AND BONALIVE PLATES · Vivoxid , Ltd. · Jun 25, 2007
K092541 — INTERFACE · Biostructures · Nov 9, 2010

Submission Summary (Full Text)

{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. July 11, 2023 Bonalive Biomaterials, Ltd. % Elisa Maldonado-Holmertz RA/OA Consultant Obelix Consulting, LLC 806 Jefferson St Bastrop, Texas 78602 Re: K231528 Trade/Device Name: Bonalive Orthopedics granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV Dated: May 24, 2023 Received: May 26, 2023 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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). Sincerely, # Jesse Muir -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231528 Device Name Bonalive® Orthopedics granules #### Indications for Use (Describe) Bonalive® Orthopedics 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. Bonalive® Orthopedics 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." {3}------------------------------------------------ ## K231528 510(k) Summary #### 1. Submission Sponsor Kristoffer Sibelius Business Development Manager Bonalive Biomaterials Ltd. Biolinja 12 20750 Turku Finland Email: kristoffer.sibelius@bonalive.com Tel number: +358 40 031 8013 ### 2. Submission Correspondent Obelix Consulting, LLC 806 Jefferson St Bastrop, TX 78602 USA Elisa Maldonado-Holmertz RA/QA Consultant Email: elisamh@obelixconsult.com Tel number: 512.431.6069 #### 3. Date Prepared 24 May 2023 #### 4. Device Identification | Type of 510(k) Submission: | |----------------------------| | Trade or Proprietary Name: | | Common or Usual Name: | | Regulation Description: | | Regulation Classification: | | Product Code: | | Class of Device: | | Review Panel: | | Reason for Submission: | | Prior Related Submissions: | | Multiple Devices: | Traditional Bonalive Orthopedic granules Filler, Bone Void, Calcium Compound Resorbable calcium salt bone void filler device 888.3045 MQV Class II Orthopedic Labeling Change K191274 None #### 5. Legally Marketed Predicate Device(s) Predicate: K191274 Bonalive® granules by Bonalive Biomaterials, Ltd. Reference: K113871 Pro-Dense Bone Graft Substitute by Wright Medical Technology, Inc. {4}------------------------------------------------ ## 6. Device Description Bonalive® Orthopedics granules is composed of osteostimulative calcium-phosphoroussodium-silicate (glass 553P4) granules (size 0.5-0.8 mm or 1.0-2.0 mm) and is a sterile medical device. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P₂O₃. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its abilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area. In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone. The Bonalive® Orthopedics granules resorb and are replaced with bone slowly over a period of years. The bioactive glass in the Bonalive® Orthopedics granules is radiodense thus enabling postoperative radiologic evaluation. Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use. Bonalive® Orthopedics granules is sterilized by irradiation and is available in different granule and unit sizes. ### 7. Indication for Use Statement Bonalive® Orthopedics 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. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process. RX Only #### 8. Substantial Equivalence Discussion The following table compares the subject device to the predicate and reference devices with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. | Manufacturer | Subject Device | Predicate Device | Reference Device | Significant Differences | |--------------|----------------------------|----------------------------|------------------|-------------------------| | | Bonalive Biomaterials, Ltd | Bonalive Biomaterials, Ltd | | | | | | | Wright | | | | | | Medical | | | | | | Technology | | #### Comparison of Characteristics {5}------------------------------------------------ | Trade Name | Bonalive® Orthopedics granules | Bonalive® granules | Pro-Dense Bone Graft Substitute | | Manufacturer | Subject Device | Predicate Device | Reference Device | Significant Differences | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-----------------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | 510(k) Number | | K191274 | K113871 | | | Bonalive Biomaterials, Ltd | Bonalive Biomaterials, Ltd | Wright Medical Technology | | | Product Code | MQV | MQV | MQV | None | Trade Name | Bonalive® Orthopedics granules | Bonalive® granules | Pro-Dense Bone Graft Substitute defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The PRO- DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide | | | 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 | Bonalive® Orthopedics 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. Bonalive® Orthopedics granules resorbs and is replaced with bone during the healing process. | Bonalive® granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bonalive® granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be the result of surgically created osseous defects or osseous defects created from traumatic injury to the. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, Bonalive® granules is intended to be used alone. | PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ . These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous | Labeling Change from K191274 Same as K113871: “may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old)” | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | Manufacturer | Subject Device Bonalive Biomaterials, Ltd | Predicate Device Bonalive Biomaterials, Ltd | Reference Device Wright Medical Technology | Significant Differences | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Trade Name | Bonalive® Orthopedics granules | Bonalive® granules | Pro-Dense Bone Graft Substitute | | | | | | structural support during the healing process. PRO-DENSE® is provided sterile for single use only. | | | Rx or OTC | Rx | Rx | Rx | None | | Physical Form | Amorphous, non-porous random-shaped particles | Amorphous, non-porous random-shaped particles | Resultant paste | None - Predicate | | Color | Brown | Brown | White | None – Predicate | | Materials Composition | SiO2, Na2O, CaO and P2O5 | SiO2, Na2O, CaO and P2O5 | CaSO4, CaPO4 | None - Predicate | | Product Sizes | 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: 0.5-0.8 mm 1.0-2.0 mm Product volumes: 1 cc 2.5 cc 5 cc 10 cc | Product volumes: 4, 10, 20 cc | None - Predicate | | Biocompatibility | Biocompatible ISO 10993 | Biocompatible ISO 10993 | Biocompatibl e ISO 10993 | None | | Sterilization | Gamma Sterile, SAL 10-6 | Gamma Sterile, SAL 10-6 | Ethylene oxide | None - Predicate | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non- pyrogenic | None | | Single Use/ Reuse | Single use only | Single use only | Single use only | None | | Manufacturer | Subject Device | Predicate Device | Reference Device | Significant Differences | | | Bonalive Biomaterials, Ltd | Bonalive Biomaterials, Ltd | Wright Medical Technology | | | Trade Name | Bonalive® Orthopedics granules | Bonalive® granules | Pro-Dense Bone Graft Substitute | | | Mode of action | Works by leaching out 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 out 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. | Angiogenesis . Reso-ption of the PRO- DENSE™ scaffold releases bound proteins. Active proteins recruit cells to the implant surface. | None - Predicate | | Properties | Synthetic Osteoconductive | Synthetic Osteoconductive | Synthetic Osteoconductive | None | | MR Safety | MR Safe | MR Safe | MR Safe | None | {8}------------------------------------------------ #### 9. Non-Clinical Performance Data The following testing was performed on the predicate K191274 Bonalive® granules. No changes have been made to the subject device Bonalive® Orthopedics granules materials, manufacturing, or sterilization processes. - Apatite - Composition Heavy Metals . - . Crystallinity - Particle Size Distribution . - Surface Area ● - Manufacturing & Specifications Validation . {9}------------------------------------------------ ## 10. 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". The following biocompatibility studies were successfully performed on the predicate K191274 Bonalive® granules. No changes have been made to the subject device Bonalive® Orthopedics granules materials, manufacturing, or sterilization processes. - Cytotoxicity - Sensitization - Systemic toxicity ● - Genotoxicity - Muscle Implantation - Pyrogen ### 11. Sterility and Shelf Life The following testing was performed on the predicate K191274 Bonalive® granules. No changes have been made to the subject device Bonalive® Orthopedics granules materials, manufacturing, or sterilization processes. - EN ISO 11137 – Radiation Sterilization Validation - . ISO 11607 - Packaging for terminally sterilized medical devices ### 12. 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. #### 13. Statement of Substantial Equivalence Bonalive® Orthopedics granules is substantially equivalent to the predicate device as it has the same design, materials, mode of action, manufacturing and sterilization processes, and technological characteristics as the previously cleared predicate device, and the subject device does not raise new questions regarding its safety and effectiveness as compared to the predicate device.