Synthetic Bone Putty

K240458 · Ventris Medical · MQV · Mar 7, 2024 · Orthopedic

Device Facts

Record IDK240458
Device NameSynthetic Bone Putty
ApplicantVentris Medical
Product CodeMQV · Orthopedic
Decision DateMar 7, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3045
Device ClassClass 2
AttributesTherapeutic

Intended Use

Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Device Story

Synthetic Bone Putty is a bone void filler composed of biphasic ceramic granules in an alkylene oxide polymer carrier. It is designed to be packed into bony voids or gaps in the pelvis, posterolateral spine, or intervertebral disc space. The device acts as a scaffold that is resorbed and replaced by host bone during the healing process. It is intended for use by surgeons in orthopedic procedures, either as a standalone filler or as an autograft extender. When used in intervertebral body fusion, it must be used in conjunction with a cleared intervertebral body fusion device. The device provides a physical medium to support bone regeneration in non-load-bearing defects.

Clinical Evidence

No clinical data. Performance is supported by bench testing, biocompatibility, sterility, and shelf-life data leveraged from the reference device (K221644), alongside a robust analysis of bone grafting materials in prior posterolateral spine fusion studies.

Technological Characteristics

Biphasic ceramic granules in an alkylene oxide polymer carrier. Resorbable calcium salt bone void filler. Form factor is a putty for manual packing. Sterilization and biocompatibility specifications follow Class II Special Controls Guidance for Resorbable Calcium Salt Bone Void Filler Devices.

Indications for Use

Indicated for patients with osseous defects of the skeletal system not intrinsic to structural stability, including surgically created defects or traumatic injuries. Sites include pelvis, posterolateral spine, or intervertebral disc space. Must be used with an FDA-cleared intervertebral body fusion device when used in intervertebral body fusion procedures.

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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ March 7, 2024 Image /page/0/Picture/1 description: The image shows 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Ventris Medical % Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group 268 Glen Place Franklin Lakes, New Jersey 07417 Re: K240458 Trade/Device Name: Synthetic Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: February 16, 2024 Received: February 16, 2024 Dear Dr. 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. 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). {1}------------------------------------------------ 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 OS 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 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, # Sara S. Thompson -S For 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 {2}------------------------------------------------ Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K240458 Device Name Synthetic Bone Putty #### Indications for Use (Describe) Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. Type of Use (Select one or both, as applicable) | <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | |------------------------------------------------------------------------------| | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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}------------------------------------------------ K240458 Image /page/4/Picture/1 description: The image shows the word "ventris" in white font on a black background. To the right of the word is a flower-like design with five petals in shades of blue and green. The font is sans-serif and appears to be bolded. There is a registered trademark symbol to the bottom right of the word. # 510(k) Summary #### Submitter John Brunelle, PhD Chief Operating Officer Ventris Medical 1201 Dove Street, Suite 470 Newport Beach, CA 92660 ### Correspondent Scott Bruder, MD, PhD Founder and CEO Bruder Consulting & Venture Group Scott(@BruderConsulting.com 201.874.9701 ### Date Prepared February 16, 2024 #### Device | Trade Name | Synthetic Bone Putty | |----------------|-----------------------------------------------------------------| | 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 Secondary Predicate Reference Device NuVasive - Attrax Putty (K203714) Prosidyan - Fibergraft™ BG Putty (K222276) Ventris Medical - Synthetic Bone Putty (K221644) #### Device Description Synthetic Bone Putty is composed of biphasic ceramic granules in an alkylene oxide polymer carrier, and it is identical to the device cleared in K221644. This submission expands the device's indication to include use in the intervertebral spine. #### Indications for Use Statement Synthetic Bone Putty is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty is indicated to be packed gently into bony voids or gaps of the pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host {5}------------------------------------------------ K240458 Image /page/5/Picture/1 description: The image shows the Ventris logo. The word "ventris" is written in white, sans-serif font on a black background. To the right of the word is a stylized flower with four petals in shades of blue and green. bone during the healing process. When used in intervertebral body fusion procedures, Synthetic Bone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. ## Substantial Equivalence The intended use is the same for subject and predicate devices. 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. ### Performance The subject device has been previously cleared under K221644, which serves as a Reference Device. This submission is 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. #### Summary 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.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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