(57 days)
No
The 510(k) summary describes a synthetic bone void filler based on a chemical reaction and physical properties. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on material properties and biocompatibility, not algorithmic performance.
Yes
Mg OSTEOINJECT™ is a bone void filler intended to support bone fragments, act as a temporary support medium, and be resorbed and replaced by bone during healing, indicating a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that Mg OSTEOINJECT is a bone void filler intended for surgical repair of bony defects, not for diagnosis. It is used as a temporary support medium and is resorbed and replaced by bone during healing.
No
The device description clearly states it is a "magnesium-based synthetic bone void filler" provided as a kit containing powder and mixing solution, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Mg OSTEOINJECT™ is a bone void filler for surgical implantation in the extremities and pelvis. It is used to support bone fragments during surgery and acts as a temporary support medium during healing. This is a therapeutic and structural application within the body.
- Device Description: The description details a magnesium-based synthetic bone void filler that is mixed and implanted. This is a physical material intended for direct interaction with bone tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. Mg OSTEOINJECT™ does not fit this description.
N/A
Intended Use / Indications for Use
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities 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. Mg OSTEOINJECT™ 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 process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Product codes
MQV, OIS
Device Description
Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data 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) were referenced from K212991. The non-clinical testing data referenced to demonstrate substantial equivalence included: chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility. Performance testing data also referenced from K212991 demonstrated 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).
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 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).
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
June 28, 2022
Image /page/0/Picture/1 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.
Bone Solutions, Inc. % Kevin A. Thomas, Ph.D. Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K221256
Trade/Device Name: Mg OSTEOINJECT™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV, OIS Dated: May 2, 2022 Received: May 2, 2022
Dear Dr. 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
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
510(k) Number (if known)
Device Name
Mg OSTEOINJECTTM
Indications for Use (Describe)
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities 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. Mg OSTEOINJECT™ 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 process. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K221256 Mg OSTEOINJECT™ Bone Solutions, Inc.
June 28, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Bone Solutions, Inc.
5712 Colleyville Boulevard, Suite 210
Colleyville, Texas 76034
Telephone +1 817-809-8850 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Drew Diaz, CEO |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 |
| San Diego, CA 92130 | |
|---|---|
| Telephone | +1 858-792-1235 |
| Fax | +1 858-792-1236 |
| kthomas@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | Mg OSTEOINJECT™ |
|---|---|
| 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 |
| Secondary Product Code | OIS |
| Classification Panel | Orthopedic |
| Reviewing Office | Office of Health Technology 6 (Orthopedic Devices) |
| Reviewing Division | Division of Health Technology 6 C |
| (Restorative, Repair and Trauma Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K212991, OSTEOREVIVE™, Bone Solutions, Inc.
Reference Device K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc.
4
INDICATIONS FOR USE STATEMENT
Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities 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. Mg OSTEOINJECT™ 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. Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
SUBJECT DEVICE DESCRIPTION
Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.
PERFORMANCE DATA
Non-clinical testing data 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) were referenced from K212991. The non-clinical testing data referenced to demonstrate substantial equivalence included: chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility. Performance testing data also referenced from K212991 demonstrated 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).
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 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).
No clinical data were included in this submission.
5
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device K212991 and the reference device K140375. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device and the primary predicate device.
The primary predicate device is K212991, for the identical formulation, packaging, and sterilization as the subject device. The subject device differs from K212991 in terms of the indications for use; the subject device is indicated only for use in the extremities and pelvis.
The reference device K140375 is for support of substantial equivalence of the subject device provided in a kit with a volume of 3 cc. The reference device K140375 includes the same indications for use in the extremities and pelvis and includes a range of volumes from 0.75 cc to 9 cc.
The subject device and the primary predicate device K21299 have the same intended use, the same product classification and product codes (MQV and OIS), and have similar Indications for Use statements. The subject device, the primary predicate device, and the reference device are indicated for use as bone void fillers in the extremities and pelvis. Although the subject device, the primary predicate device, and the reference device 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 reference device 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 (reference device). The subject device and primary predicate device have identical materials and formulation and are mixed intra-operatively. The subject device, the primary predicate device, and the reference device are all provided in comparable volumes, sterilized by irradiation, and are for single-patient, single-use.
Differences among the subject device, the primary predicate device, and the reference device include the exact indications for use (including use in the posterolateral spine for the primary predicate and reference device), the mineral components, and the scaffold or binder material (bovine collagen in the reference device K 140375). The minor differences among the subject device, the primary predicate device, and the reference device 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 reference device have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and the primary predicate device are manufactured from identical materials. The subject device, the primary predicate, and the reference device encompass the same range of physical dimensions (volumes), are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate device and the reference device listed above.
6
Table of Substantial Equivalence
| Features / Comparisons | Subject Device | Primary Predicate Device |
|---|---|---|
| Mg OSTEOINJECTTM | ||
| Bone Solutions Inc. | K212991 | |
| OSTEOREVIVETM | ||
| Bone Solutions Inc. | ||
| Indications for Use Statement | Mg OSTEOINJECTTM is intended for bony voids | |
| or defects of the extremities 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. | ||
| Mg OSTEOINJECTTM can be used as an adjunct to | ||
| conventional rigid hardware fixation by supporting | ||
| the bone fragments during the surgical procedure. | ||
| Once the material has set, it acts as a temporary | ||
| support medium and is not intended to provide | ||
| structural support during the healing process. | ||
| Mg OSTEOINJECTTM is intended to be placed into | ||
| bony voids either before or after final fixation. | ||
| Mg OSTEOINJECTTM is resorbed and replaced | ||
| with bone during the healing process. Mg | ||
| OSTEOINJECTTM is not intended to treat large | ||
| defects that in the surgeon's opinion would fail to | ||
| heal spontaneously | OSTEOREVIVETM 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. | ||
| OSTEOREVIVETM can be used as an adjunct to | ||
| conventional rigid hardware fixation by supporting | ||
| the bone fragments during the surgical procedure. | ||
| Once the material has set, it acts as a temporary | ||
| support medium and is not intended to provide | ||
| structural support during the healing process. | ||
| OSTEOREVIVETM is intended to be placed into | ||
| bony voids either before or after final fixation. | ||
| OSTEOREVIVETM is resorbed and replaced with | ||
| bone during the healing process. | ||
| OSTEOREVIVETM must be used with morselized | ||
| autograft bone at a ratio of 1:1 by volume in the | ||
| posterolateral spine. | ||
| OSTEOREVIVETM is not intended to treat large | ||
| defects that in the surgeon's opinion would fail to | ||
| heal spontaneously. | ||
| Reason for Predicate/Reference | ||
| Device | Not applicable - Subject Device | Identical or similar indications for use, formulation, |
| packaging, and sterilization | ||
| Product Codes | MQV, OIS | MQV, OIS |
| Intended Use | Bone void filler for skeletal system; | |
| extremities and pelvis | Bone void filler for skeletal system; | |
| extremities, pelvis, and posterolateral spine | ||
| Design | ||
| Form | Powder and liquid components; | |
| after mixing device is injectable and sets in the | ||
| surgical site | Powder and liquid components; | |
| after mixing device is injectable and sets in the | ||
| surgical site | ||
| Granule Size | Not applicable, non-porous solid after mixing and | |
| setting | Not applicable, non-porous solid after mixing and | |
| setting | ||
| Porosity | Not applicable, non-porous solid after mixing and | |
| setting | Not applicable, non-porous solid after mixing and | |
| setting | ||
| Materials | ||
| Mineral component | ||
| Calcium/other salts | β-tricalcium phosphate (8%) | |
| Magnesium oxide (41%) | ||
| Monopotassium phosphate (44%) | ||
| Monosodium phosphate (3%) | β-tricalcium phosphate (8%) | |
| Magnesium oxide (41%) | ||
| Monopotassium phosphate (44%) | ||
| Monosodium phosphate (3%) | ||
| Scaffold/Binder | None | None |
| Indicted for Use in | ||
| Extremities and Pelvis | Yes | Yes |
| Mix with autograft bone prior | ||
| to use | No | |
| Not indicated for mixing with autograft in | ||
| extremities or pelvis | No | |
| Not indicated for mixing with autograft in | ||
| extremities or pelvis | ||
| Indicated for Use in | ||
| Posterolateral Spine | No | Yes |
| Mix with autograft bone prior | ||
| to use | Not applicable – not indicated for use in | |
| posterolateral spine | Required to mix with autograft 1:1 by volume for | |
| use in the posterolateral spine | ||
| Features / Comparisons | Subject Device | Primary Predicate Device |
| Mg OSTEOINJECTTM | ||
| Bone Solutions Inc. | K212991 | |
| OSTEOREVIVETM | ||
| Bone Solutions Inc. | ||
| How Provided | ||
| Sizes | Kits of powder and liquid components for volumes of: | |
| 3 cc and 5 cc | Kits of powder and liquid components for volumes of: | |
| 5 cc, 10 cc, and 15 cc | ||
| Sterility | Provided sterile to end user | Provided sterile to end user |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Usage | Single-patient, single-use | Single-patient, single-use |
7