(48 days)
No
The document describes a synthetic bone void filler material and its intended use. There is no mention of any software, algorithms, image processing, or AI/ML capabilities.
Yes
The device is described as a magnesium-based synthetic bone void filler intended to be placed into bony voids or defects to support bone fragments and provide a temporary support medium, which is resorbed and replaced with bone during the healing process. This directly relates to the repair or modification of the body's structure or function, fitting the definition of a therapeutic device.
No
The device is a magnesium-based synthetic bone void filler intended to fill bony voids or defects and provide temporary support during surgical procedures and healing, not for diagnosing medical conditions.
No
The device is a physical bone void filler composed of a powder and mixing solution, not software.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes the devices as being implanted into the body to fill bony voids and defects. This is an in-vivo application, meaning it's used within a living organism.
- Device Description: The description details a magnesium-based synthetic bone void filler that is mixed and implanted during surgery. This is a medical device used for treatment or support within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, based on the provided text, Mg OSTEOINJECT™, Mg OSTEOREVIVE™, and Mg OSTEOCRETE™ are medical devices intended for surgical implantation, not In Vitro Diagnostic devices.
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 osseous defects may be the result of benign bone cysts and tumors (in adults), 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.
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral disc space, and pelvis that are not intrinsic to the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg 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.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ 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 OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Product codes (comma separated list FDA assigned to the subject device)
MQV, OIS
Device Description
This submission includes three devices with three separate trade names bundled into the single 510(k) application. The purpose of this application is to expand the indications to include specific language for the use of all three devices for benign bone cysts and tumors (in adults), and to expand the indications for use of two of the devices (Mg OSTEOREVIVE™ and Mg OSTEOCRETE™) to include use with intervertebral body fusion device cleared by FDA for use with a bone void filler. The subject devices are a magnesium-based synthetic bone void filler that is moldable, injectable, drillable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices comprises a powder component (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 devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, pelvis, posterolateral spine, intervertebral disc space
Indicated Patient Age Range
Adults for benign bone cysts and tumors where specified.
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 leveraged from K071004 to demonstrate substantial equivalence included: chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility. Performance testing data also leveraged 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). Animal testing data were leveraged from K212991 and K071004.
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
§ 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.
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February 5, 2024
Bone Solutions, Inc. % Kevin A. Thomas, Ph.D. VP & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K234013
Trade/Device Name: Mg OSTEOINJECT™: Mg OSTEOREVIVE™; Mg OSTEOCRETE™ Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV, OIS Dated: December 18, 2023 Received: December 19, 2023
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 (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/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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
2
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) K234013
Device Name
Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™
Indications for Use (Describe)
Mg OSTEOINJECTTM
Mg OSTEOINIECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), 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.
Mg OSTEOREVIVE™
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg 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.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be tysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETE™ 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 OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETETM must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETE™ 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)
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary K234013 Mg OSTEOINJECT™, Mg OSTEOREVIVE™, Mg OSTEOCRETE™ Bone Solutions, Inc.
January 31, 2024
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
Telephone +1 858-792-1235
Fax +1 858-792-1236
Email kthomas@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
Trade/Device Name | Mg OSTEOINJECT™, Mg OSTEOREVIVE™, Mg OSTEOCRETE™ |
---|---|
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
Predicate Devices K232315, Catalyst Bone Void Filler, OssDsign AB K231528, Bonalive Orthopedics granules, Bonalive Biomaterials, Ltd.
Reference Devices K071004, OsteoCrete™ Bone Void Filler, Bone Solutions Inc. K212991, OSTEOREVIVE™, Bone Solutions Inc.
6
INDICATIONS FOR USE STATEMENT
Mg OSTEOINJECTTM
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 osseous defects may be the result of benign bone cysts and turnors (in adults), 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.
Mg OSTEOREVIVE™
Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral disc space, and pelvis that are not intrinsic to the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg 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.
Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
Mg OSTEOCRETE™
Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.
Mg OSTEOCRETM 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 OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETETM must be used with morselized autograft bone in the posterolateral spine.
When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
Mg OSTEOCRETM is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
SUBJECT DEVICE DESCRIPTION
This submission includes three devices with three separate trade names bundled into the single 510(k) application. The purpose of this application is to expand the indications to include specific language for the use of all three devices for benign bone cysts and tumors (in adults), and to expand the indications for use of two of the devices (Mg OSTEOREVIVE™ and Mg OSTEOCRETE™) to include use with intervertebral body fusion device cleared by FDA for use with a bone void filler. The subject devices are a magnesium-based synthetic bone void filler that is moldable, injectable, drillable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices comprises a powder component (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
7
cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 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 leveraged from K071004 to demonstrate substantial equivalence included: chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility. Performance testing data also leveraged 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). Animal testing data were leveraged from K212991 and K071004.
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.
EQUIVALENCE TO MARKETED DEVICES
The subject devices and the predicate devices have intended use, the same product classification, product codes (MQV), and have similar Indications for Use statements, with the additions to the subject device Indications for Use described above. Although the subject devices and the predicate devices have slightly different Indications for Use language, these differences in language do not change the intended use as a bone void filler.
Differences among the subject devices and the predicate device include the exact indications for use language, the mineral components, and the scaffold or binder material (K232315). These minor differences do not raise new issues of safety or effectiveness, and therefore, do not impact substantial equivalence.
CONCLUSION
The subject devices and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject devices and predicate devices 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 devices listed above.
8
Table of Substantial Equivalence
Subject Device | Primary Predicate Device | ||
---|---|---|---|
Features / Comparisons | K234013 | ||
Mg OSTEOINJECTTM, Mg OSTEOREVIVETM, | |||
Mg OSTEOCRETETM | |||
Bone Solutions Inc. | K232315 | ||
Catalyst Bone Void Filler | |||
OssDsign AB | |||
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 osseous defects may be the result of | |||
benign bone cysts and tumors (in adults), 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 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 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. | Catalyst Bone Void Filler is indicated for filling bone voids or defects of the skeletal system (i.e., | ||
the posterolateral spine, intervertebral disc space, extremities, and pelvis) that are not intrinsic to | |||
the stability of the bony structure. | |||
These osseous defects may be surgically created or as a result of traumatic injury to the bone. | |||
Catalyst Bone Void Filler is a bone graft putty that is resorbed and replaced with bone during the | |||
healing process. | |||
Catalyst Bone Void Filler must be used with morselized autograft bone at a ratio of 1:1 by volume | |||
in the posterolateral spine. When used in intervertebral body fusion procedures, Catalyst Bone | |||
Void Filler must be used with morselized autograft bone at a ratio of 1: 1 by volume with an | |||
intervertebral body fusion device cleared by FDA for use with a bone void filler. | Bonalive® | ||
system (i.e., | |||
These osseous | |||
patients > ( | |||
not intrinsic | |||
Bonalive® | |||
Mg OSTEOREVIVETM is intended for bony voids or defects of the extremities, posterolateral | |||
spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony | |||
structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), | |||
may be surgically created osseous defects or osseous defects created by traumatic injury to the | |||
bone. | |||
Mg OSTEOREVIVETM 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 OSTEOREVIVETM is intended to be placed into bony voids either before or after final | |||
fixation. | |||
Mg OSTEOREVIVETM is resorbed and replaced with bone during the healing process. | |||
Mg OSTEOREVIVETM must be used with morselized autograft bone in the posterolateral spine. | |||
When used in intervertebral body fusion procedures Mg OSTEOREVIVETM must be used with | |||
morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with | |||
a bone void filler. | |||
Mg OSTEOREVIVETM is not intended to treat large defects that in the surgeon's opinion would | |||
fail to heal spontaneously. | |||
Mg OSTEOCRETETM is intended for bony voids or defects of the extremities, posterolateral | |||
spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony | |||
structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), | |||
may be surgically created osseous defects or osseous defects created by traumatic injury to the | |||
bone. | |||
Mg OSTEOCRETETM 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 OSTEOCRETETM is intended to be placed into bony voids either before or after final fixation. | |||
Mg OSTEOCRETETM is resorbed and replaced with bone during the healing process. | |||
Mg OSTEOCRETETM must be used with morselized autograft bone in the posterolateral spine. | |||
When used in intervertebral body fusion procedures Mg OSTEOCRETETM must be used with | |||
morselized autograft bone with an intervertebral body fusion device cleared by FDA for use with | |||
a bone void filler. | |||
Mg OSTEOCRETETM is not intended to treat large defects that in the surgeon's opinion would fail | |||
to heal spontaneously. | |||
Features / Comparisons | Subject Device | Primary Predicate Device | |
K234013 | |||
Mg OSTEOINJECT™, Mg OSTEOREVIVE™, | |||
Mg OSTEOCRETE™ | |||
Bone Solutions Inc. | K232315 | ||
Catalyst Bone Void Filler | |||
OssDsign AB | |||
Reason for Predicate/Reference Device | Not applicable - Subject Device | Indications for use | Indications for use |
Product Codes | MQV, OIS | MQV | MQV |
Intended Use | Bone void filler for skeletal system; | ||
extremities, pelvis, and posterolateral spine, and with an intervertebral body fusion device FDA | |||
cleared for use with a bone void filler | Bone void filler for skeletal system; | ||
extremities, pelvis, and posterolateral spine, and with an intervertebral body fusion device FDA | |||
cleared for use with a bone void filler | Bone void filler | ||
Extremities | |||
Design | |||
Form | Powder and liquid components; | ||
after mixing and placement the device sets in the surgical site; can be injected in the surgical site | 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel | Amorphous | |
Materials | |||
Mineral component | |||
Calcium/other salts | β-tricalcium phosphate (8%) | ||
Magnesium oxide (41%) | |||
Monopotassium phosphate (44%) | |||
Monosodium phosphate (3%) | 5.8 wt% silicon-substituted calcium phosphate | ||
(granules 30 wt% of final device) | SiO2, | ||
Scaffold/Binder | None | Polymer gel (70 wt% of final device) | None |
Indicated for Use in | |||
Extremities and Pelvis | Yes | 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 | No | ||
Not indicated | |||
Indicated for Use in | |||
Posterolateral Spine | Yes | Yes | No |
Mix with autograft bone prior to use | Required to mix with autograft 1:1 by volume for use in the posterolateral spine | Required to mix with autograft 1:1 by volume for use in the posterolateral spine | Not applicable |
Indicated for Use in the intervertebral disc space | Yes | Yes | Not applicable |
Mix with autograft bone prior to use | Required to mix with autograft 1:1 by volume for use | ||
in with an intervertebral body fusion device cleared | |||
by FDA for use with a bone void filler | Required to mix with autograft 1:1 by volume for use in with an intervertebral body fusion device | ||
cleared by FDA for use with a bone void filler | Not applicable | ||
How Provided | |||
Sizes | Kits of powder and liquid components for volumes of: | ||
3 cc, 5 cc, 10 cc, and 15 cc | Volumes of 1 cc, 2.5 cc, 5 cc, 10 cc | Volumes of 1 cc | |
Sterility | Provided sterile to end user | Provided sterile to end user | Provided sterile |
Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
Usage | Single-patient, single-use | Single-patient, single-use | Single-patient |
Predicate Device K231528 Bonalive Orthopedics granules
Bonalive Biomaterials, Ltd.
® Orthopedics granules is an implant intended to fill bony voids or gaps of the skeletal
e., extremities and pelvis).
seous defects may be the result of benign bone cysts and tumors (in adults and pediatric
e 6 years old), are surgically created or the result of traumatic injury to the bone sic to the stability of the bony structure.
® Orthopedics granules resorbs and is replaced with bone during the healing process.
® Orthopedics granules resorbs and is replaced with bone during the healing process.
9
Predicate Device K231528
Bonalive Orthopedics granules
Bonalive Biomaterials, Ltd.
ons for use
oid filler for skeletal system;
ities and pelvis
ous, non-porous, random-shaped particles
a2O, CaO , P2O5
cated for mixing with autograft in extremities or pelvis
licable – not indicated for use in posterolateral spine licable – not indicated for use in the intervertebral disc space licable
s of 1 cc, 2.5 cc, 5 cc, 10 cc
d sterile to end user irradiation
atient, single-use