Osteorevive

{0}------------------------------------------------ March 23, 2022 Image /page/0/Picture/1 description: The image contains 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. Bone Solutions, Inc. % Kevin Thomas, PhD Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130 Re: K212991 Trade/Device Name: OSTEOREVIVE™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, OIS Dear Kevin Thomas: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 21, 2022. Specifically, FDA is updating this SE Letter to include all relevant product codes on the SE letter - as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Laura Rose, Ph.D., OHT6: Office of Orthopedic Devices, by phone at (301) 348-1947 or email at Laura.Rose@fda.hhs.gov. Sincerely, Laura C. Rose -S Laura C. Rose, 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 {1}------------------------------------------------ January 21, 2022 Image /page/1/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the administration in blue text. Bone Solutions, Inc. % Kevin Thomas, Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130 #### Re: K212991 Trade/Device Name: OSTEOREVIVE™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: December 21, 2021 Received: December 22, 2021 Dear Kevin Thomas: 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 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 {2}------------------------------------------------ 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Pooja Panigrahi -S for Laura C. Rose, 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) K212991 Device Name OSTEOREVIVE™ Indications for Use (Describe) OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects created by traumatic injury to the bone. OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. OSTEOREVIVE™ must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously. | 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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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 K212991 OSTEOREVIVE™ Bone Solutions, Inc. January 21, 2022 #### ADMINISTRATIVE INFORMATION | Manufacturer Name | Bone Solutions, Inc.<br>5712 Colleyville Boulevard, Suite 210<br>Colleyville, Texas 76034<br>Telephone +1 817-809-8850 | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Drew Diaz, CEO | | Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone +1 858-792-1235 | Fax Email +1 858-792-1236 kthomas@paxmed.com flarson@paxmed.com #### DEVICE NAME AND CLASSIFICATION | Trade/Device Name | OSTEOREVIVE™ | |----------------------|-------------------------------------------------------------------------------| | Common Name | Filler, bone void, calcium compound | | Regulation Number | 21 CFR 888.3045 | | Regulation Name | Resorbable calcium salt bone void filler device | | Regulatory Class | Class II | | Product Code | MQV | | Classification Panel | Orthopedic | | Reviewing Office | Office of Health Technology 6 (Orthopedic Devices) | | Reviewing Division | Division of Health Technology 6 C<br>(Restorative, Repair and Trauma Devices) | #### PREDICATE DEVICE INFORMATION Primary Predicate Device K071004, OsteoCrete™ Bone Void Filler, Bone Solutions, Inc. Additional Predicate Devices K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc. K173362, DSM Biomedical Calcium Phosphate Cement, Kensey Nash Corporation dba DSM Biomedical {5}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation. OSTEOREVIVE™ is resorbed and replaced with bone during the healing process. OSTEOREVIVE™ must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine. OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously. #### SUBJECT DEVICE DESCRIPTION OSTEOREVIVE™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. OSTEOREVIVE™ consists of a powder component and a liquid component (modified saline solution) that are mixed at the time of surgery. The powder components include ß-tricalcium phosphate, magnesium oxide, monopotassium phosphate, and monosodium phosphate. The mixing liquid is saline with monosodium phosphate. After mixing and setting OSTEOREVIVE™ is a non-porous solid material. OSTEOREVIVE™ is provided sterile to the end user in 5 cc, 10 cc, and 15 cc sizes. #### PERFORMANCE DATA Non-clinical testing data were submitted according to the guidance documents Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (issued June 2003) and Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 2016). The non-clinical testing data submitted, referenced from K071004, or relied upon to demonstrate substantial equivalence included: chemical composition, physical properties, sterilization, sterile barrier shelf life, and biocompatibility. Bacterial endotoxin testing has been performed to ensure the device meets pyrogen limit specifications. The Limulus amebocyte lysate (LAL) test, kinetic turbidimetric method, was performed according to USP <85> Bacterial Endotoxins Test. The LAL testing met the limit acceptance criterion of ≤ 20 EU/device, based upon the recommendations for implanted devices in the FDA guidance document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, issued January 21, 2016 (Section V, A, 4). Performance testing data also were submitted to demonstrate that the subject device is drillable, and may be used as an adjunct to conventional rigid hardware during the surgical procedure (only when used in the extremities and pelvis). Animal testing was performed in a rabbit posterolateral spine fusion model to demonstrate substantial equivalence to the additional predicate device K140375. Animals were evaluated after implantation with the subject device, the additional predicate device K140375, and autograft (positive control). The study {6}------------------------------------------------ time points included baseline (time 0), 6 weeks, and 12 weeks; subject device animals also were evaluated at 2 hours, 3 days. Evaluation endpoints included radiography, manual palpation, range of motion/flexibility testing, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to ISO 10993-6 (Annex E). No clinical data were included in this submission. #### EQUIVALENCE TO MARKETED DEVICES The subject device is substantially equivalent in indications and design principles to the primary predicate device and the additional predicate devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the additional predicate devices. The primary predicate device is K071004, for the identical formulation, packaging, and sterilization as the subject device. The subject device differs from K071004 only in terms of the additional indications for use in the posterolateral spine and the claims regarding drillable properties. The predicate device is K140375 for support of substantial equivalence in the posterolateral spine animal model performance testing. The predicate device K173362 for support of substantial equivalence in terms of the indications for use associated with the additional product code OIS. The subject device, the primary predicate device K071004, and the additional predicate devices K140375 and K173362 have the same intended use, the same product classification and product code (MOV), and have similar Indications for Use statements. The subject device, the primary predicate device, and the additional predicate devices are indicated for use as bone void fillers in the extremities and pelvis. The subject device and the predicate device K140375 are indicated for use with autograft bone (as a bone graft extender) in the posterolateral spine; K140375 also is indicated for stand-alone use in the posterolateral spine. Although the subject device, the primary predicate device, and the additional predicate devices have slightly different Indications for Use language, these differences in language do not change the intended use as a bone void filler. The subject device, the primary predicate device, and the additional predicate devices all incorporate calcium phosphate materials that are mixed to form a solid after setting (subject device and primary predicate device) or are within a polymeric binder or scaffold (additional predicate devices). The subject device and primary predicate device have identical materials, formulation and processing; the subject device is mixed to form a non-porous solid after setting. The radiographic, histologic, and histomorphometric performance of the subject device was compared to that of the primary predicate device K140375 in a rabbit posterolateral fusion model. The results of the study demonstrated the performance of the subject device was equivalent to that of the predicate device K140375 in the posterolateral spine. Performance testing provided demonstrated the subject device to be substantially equivalent to the additional predicate K173362 in terms of the indications associated with the additional product code OIS. Differences among the subject device, the primary predicate device, and the additional predicate devices include the exact indications for use in the posterolateral spine (mixed with autograft or used alone), the {7}------------------------------------------------ calcium phosphate and other mineral components, and the scaffold or binder material (bovine collagen in the additional predicate devices K140375 and K173362). The subject device and the predicate devices are all provided in comparable volumes, sterilized by irradiation, and are for single-patient, single-use. The similarities described, combined with the animal performance testing, support substantial equivalence of the subject device. The minor differences among the subject device, the primary predicate device, and the additional predicate devices do not raise new issues of safety or effectiveness, and therefore, do not impact substantial equivalence. #### CONCLUSION The subject device, the primary predicate device, and the additional predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device, the primary predicate, and the additional predicate devices encompass the same range of physical dimensions, are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the additional predicate devices listed above. {8}------------------------------------------------ # 510(k) Summary Page 5 of 5 able of Substantial Equivalend | Comparison | Subject Device | Primary Predicate Device | Predicate Device | Predicate Device | |------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use Statement | K212991<br>OSTEOREVIVETM<br>Bone Solutions Inc. | K071004<br>OsteoCrete™ Bone Void Filler<br>Bone Solutions Inc. | K140375<br>MASTERGRAFT® Strip; MASTERGRAFT® Putty<br>Medtronic Sofamor Danek USA, Inc. | K173362<br>DSM Biomedical Calcium Phosphate Cement<br>Kensey Nash Corporation dba DSM Biomedical | | | OSTEOREVIVETM is intended for bony voids or defects of the<br>extremities, posterolateral spine, and pelvis that are not intrinsic to the<br>stability of the bony structure. These defects may be surgically created<br>osseous defects or osseous defects created by traumatic injury to the<br>bone. OSTEOREVIVETM can be used as an adjunct to conventional rigid<br>hardware fixation by supporting the bone fragments during the surgical<br>procedure. Once the material has set, it acts as a temporary support<br>medium and is not intended to provide structural support during the<br>healing process. OSTEOREVIVETM is intended to be placed into bony<br>voids either before or after final fixation. OSTEOREVIVETM is resorbed<br>and replaced with bone during the healing process. OSTEOREVIVETM<br>must be used with morselized autograft bone at a ratio of 1:1 by volume<br>in the posterolateral spine. OSTEOREVIVETM is not intended to treat<br>large defects that in the surgeon's opinion would fail to heal<br>spontaneously. | Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is intended only for<br>bony voids or defects that are not intrinsic to the stability of the bony<br>structure. Bone Solutions, Inc., OsteoCrete™ Bone Void Filler is<br>intended to be placed or injected into bony voids or gaps of the skeletal<br>system (the long bone and pelvis). These defects may be surgically<br>created osseous defects or osseous defects created from traumatic injury<br>to the bone. The product provides a bone void filler that resorbs and is<br>replaced with bone during the healing process. OsteoCrete™ Bone Void<br>Filler is not intended to treat large defects that in the surgeon's opinion<br>would fail to heal spontaneously. | MASTERGRAFT® Putty combined with either autogenous bone marrow,<br>and/or sterile water, and/or autograft is indicated as a bone void filler for<br>bony voids or gaps that are not intrinsic to the stability of the bony<br>structure. Additionally, MASTERGRAFT® Putty can be used with<br>autograft as a bone graft extender. MASTERGRAFT® Putty is to be<br>gently packed into bony voids or gaps of the skeletal system (e.g., the<br>posterolateral spine, pelvis, ilium, and/or extremities). These defects may<br>be surgically created osseous defects or osseous defects created from<br>traumatic injury to the bone. MASTERGRAFT® Putty resorbs and is<br>replaced with bone during the healing process. | DSM Biomedical Calcium Phosphate Cement is indicated to fill bony<br>voids or gaps of the skeletal system (i.e. extremities and pelvis). These<br>defects may be surgically created or osseous defects created from<br>traumatic injury to the bone. The DSM Biomedical Calcium Phosphate<br>Cement is indicated only for bony voids or gaps that are not intrinsic to<br>the stability of the bony structure. The DSM Biomedical Calcium<br>Phosphate Cement cured in situ provides an open void/ gap filler that<br>can augment provisional hardware (e.g. K-Wires, plates, screws) to help<br>support bone fragments during the surgical procedure. The cured cement<br>acts only as a temporary support media and is not intended to provide<br>structural support during the healing process. The Calcium Phosphate<br>Cement resorbs and is replaced by bone during the healing process. | | Reason for Predicate/Reference Device | Not applicable - Subject Device | Identical to the subject device in materials, formulation, and<br>manufacturing | Performance in animal model in the posterolateral spine<br>(as bone graft extender with autograft) | Reference device for OIS product code and indications | | Product Code | MQV | MQV | MQV | MQV, OIS | | Intended Use | Bone void filler for skeletal system<br>(extremities, pelvis, and posterolateral spine) | Bone void filler for skeletal system<br>(extremities, pelvis) | Bone void filler for skeletal system<br>(Extremities, pelvis, and posterolateral spine) | Bone void filler for skeletal system<br>(extremities, pelvis) | | Design | | | | | | Form | Powder and liquid components;<br>after mixing device is injectable and sets in the surgical site | Same as subject device | Granules uniformly dispersed in collagen scaffold | Powder component;<br>after mixing device is injectable and sets in the surgical site | | Granule Size | Not applicable, non-porous solid after mixing and setting | Same as subject device | 0.5 mm – 1.6 mm in diameter | Not in 510(k) Summary | | Porosity | Not applicable, non-porous solid after mixing and setting | Same as subject device | Granules – 80 %<br>Final device - not stated in 510(k) Summary | Not in 510(k) Summary | | Materials | | | | | | Mineral component<br>Calcium/other salts | β-tricalcium phosphate<br>Magnesium oxide<br>Monopotassium phosphate<br>Monosodium phosphate | Same as subject device | β-tricalcium phosphate<br>Hydroxyapatite | Calcium phosphate that converts to hydroxyapatite in vivo | | Scaffold/Binder | None | Same as subject device | Type I bovine collagen | Powdered bovine collagen | | For Use in Extremities and Pelvis | Yes | Yes | Yes | Yes | | Mix with bone prior to use | Not indicated for mixing with autograft in extremities or pelvis | Not indicated for mixing with autograft in extremities or pelvis | Autograft bone (optional) | Not in 510(k) Summary | | For Use in Posterolateral Spine | Yes | No | Yes | No | | Mix with bone prior to use | Required to mix with autograft 1:1 by volume for use in the<br>posterolateral spine | Not applicable | Autograft bone (optional) | Not applicable | | How Provided |…