Mg 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 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 and/or allograft 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 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 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 and or allograft 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.

Device Description

The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive, radiopaque, and osteoconductive. The subject devices consist of 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 occurs 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding two bone void filler devices, Mg OSTEOREVIVE™ and Mg OSTEOCRETE™. This document primarily outlines the administrative information, device classification, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document states: "No clinical data were included in this submission." and focuses on non-clinical testing data leveraged from a previous submission (K234013) to demonstrate substantial equivalence, including chemical composition, physical properties, sterilization, shelf life, and biocompatibility.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and reported device performance (for AI/ML performance).
Sample sizes used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
Information on standalone (algorithm-only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How the ground truth for the training set was established.

This document pertains to the clearance of a medical device (bone void fillers) based on demonstrating substantial equivalence to existing predicate devices through non-clinical data, not on the performance evaluation of an AI/ML component.

Summary

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October 18, 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" in blue, with the word "ADMINISTRATION" underneath.

Bone Solutions, Inc % Kevin Thomas VP & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real Suite 400 San Diego, California 92130

Re: K242372

Trade/Device Name: 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, MBP Dated: August 9, 2024 Received: August 9, 2024

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 (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"

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(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 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Image /page/2/Figure/2 description: The image shows a digital signature. The signature is from JESSE MUIR. The date of the signature is 2024.10.18 at 15:27:32 -04'00'.

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K242372

Device Name

Mg OSTEOREVIVE™; Mg OSTEOCRETETM

Indications for Use (Describe)

Mg OSTEOREVIVE™

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.

allograft 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™ 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.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K242372 Mg OSTEOREVIVE™, Mg OSTEOCRETE™ Bone Solutions, Inc.

October 17, 2024

ADMINISTRATIVE INFORMATION

Manufacturer Name	Bone Solutions, Inc.5712 Colleyville Boulevard, Suite 210Colleyville, Texas 76034Telephone +1 817-809-8850
Official Contact	Drew Diaz, CEO
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Email kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	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 Codes	OIS, MBP
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 K234013, Mg OSTEOINJECT™, Mg OSTEOREVIVE™, Mg OSTEOCRETE™, Bone Solutions Inc. Reference Device K122513, MAGNIFUSE® II Bone Graft, Medtronic Sofamor Danek USA, Inc.

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INDICATIONS FOR USE STATEMENT

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 and/or allograft 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 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 autografi and or allograft 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 two devices with separate trade names bundled into the single 510(k) application. The purpose of this application is to expand the include specific language for use with autograft and/or allograft bone when used in the posterolateral spine and when used with an 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, drillable, resorbable, adhesive, radiopaque, and osteoconductive. The subject devices consist of 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 occurs 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.

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 K234013. The non-clinical testing data leveraged from K234013 to demonstrate substantial equivalence included: chemical composition, physical properties, sterilization, sterile barrier shelf life, product shelf life, and biocompatibility. Performance testing data also

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leveraged 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 also referenced in K234013.

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 8, 2024 (Section V, A, 4).

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device and the primary predicate device have intended use, the same product classification, product codes (MQV, OIS), and have similar Indications for Use statements, with the additions to the subject device Indications for Use described above. 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 and the primary predicate device are made of identical materials, provided in the same range of physical dimensions (volumes), are packaged in identical materials, and are sterilized using identical methods.

Differences between the subject device and the reference device (K122513) include the exact indications for use language, the mineral components, and the scaffold or containment system. 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 primary predicate device have the same intended use, have identical technological characteristics, and are made of identicals. The subject device and primary predicate device encompass the same range of physical dimensions (volumes), are packaged in identical materials and are sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate device and the reference device listed above.

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Table of Substantial Equivalence

Features / Comparisons	Subject DeviceK242372Mg OSTEOREVIVETM, Mg OSTEOCRETETMBone Solutions Inc.	Primary Predicate DeviceK234013Mg OSTEOINJECT™, Mg OSTEOREVIVETM, Mg OSTEOCRETETMBone Solutions Inc.	Reference DeviceK122513MAGNIFUSE® II Bone GraftMedtronic Sofamor Danek USA, Inc.
Indications for Use Statement	Mg OSTEOREVIVET™ 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. Theseosseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically createdosseous defects or osseous defects created by traumatic injury to the bone.Mg OSTEOREVIVET™ can be used as an adjunct to conventional rigid hardware fixation by supportingthe 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 structuralsupport during the healing process.Mg OSTEOREVIVET™ is intended to be placed into bony voids either before or after final fixation.Mg OSTEOREVIVET™ is resorbed and replaced with bone during the healing process.	Mg OSTEOINJECT™™ is intended for bony voids or defects of the extremities and pelvis that are notintrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cystsand tumors (in adults), may be surgically created osseous defects or osseous defects created by traumaticinjury to the bone.Mg OSTEOINJECTTM can be used as an adjunct to conventional rigid hardware fixation by supporting thebone 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 structuralsupport 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 healspontaneously.	MAGNIFUSE® II Bone Graft is intended for use as a bone graft substitute inbony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis)not intrinsic to the stability of the bony structure. The voids or gaps may besurgically created defects or defects created by traumatic injury to the bone.MAGNIFUSE® II Bone Graft is resorbed/remodeled and replaced by hostbone during the healing process.
	Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone in the posterolateralspine.When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselizedautograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with abone void filler.	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 morselizedautograft 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 toheal spontaneously.	Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to healspontaneously.
	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. Theseosseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically createdosseous defects or osseous defects created by traumatic injury to the bone.	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. Theseosseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically createdosseous defects or osseous defects created by traumatic injury to the bone.
	Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting thebone 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 structuralsupport 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™ can be used as an adjunct to conventional rigid hardware fixation by supporting thebone 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 structuralsupport 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 and/or allograft bone in the posterolateralspine.When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselizedautograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with abone void filler.	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 morselizedautograft 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 healspontaneously.	Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to healspontaneously.
	Subject Device	Primary Predicate Device	Reference Device
Features / Comparisons	K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions Inc.	K234013Mg OSTEOINJECT™, Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions Inc.	K122513MAGNIFUSE® II Bone GraftMedtronic Sofamor Danek USA, Inc.
Reason for Predicate Device	Not applicable – Subject Device	Indications for Use, formulation, packaging, sterilization,leveraged bench testing, leveraged animal testing	Indications for Use, mix allograft and autograft
Product Codes	MQV, OIS, MBP	MQV, OIS	MQV, MBP
Intended Use	Bone void filler for skeletal system;extremities, pelvis, and posterolateral spine, and with an intervertebral body fusiondevice 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 fusiondevice FDA cleared for use with a bone void filler	Bone void filler for skeletal system;pelvis and posterolateral spine
Form	Powder and liquid components;after mixing and placement the device sets in the surgical site	Powder and liquid components;after mixing and placement the device sets in the surgical site;can be injected in the surgical site	Polyglycolic acid (PGA) resorbable mesh bag provided withhuman bone allograft tissue matrix, to be mixed 1:1 withautograft bone
Mineral componentCalcium/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%)	Allograft tissue matrix
Scaffold/Binder	None	None	Polyglycolic acid (PGA) resorbable mesh bag
Indicated for Use in theExtremities and Pelvis	Yes	Yes	Yes
Mix with bone prior to use	NoNot indicated for mixing with autograft or allograft in the extremities or pelvis	NoNot indicated for mixing with autograft or allograft in the extremities or pelvis	YesMix supplied allograft 1:1 with autograft
Indicated for Use in thePosterolateral Spine	Yes	Yes	Yes
Mix with bone prior to use	YesRequired to mix with autograft and/or allograft 1:1 by volume for use in theposterolateral spine	YesRequired to mix with autograft 1:1 by volume for use in the posterolateral spine	YesMix supplied allograft 1:1 with autograft
Indicated for Use in theintervertebral disc space	Yes	Yes	No
Mix with bone prior to use	YesRequired to mix with autograft and/or allograft 1:1 by volume for use with anintervertebral body fusion device cleared by FDA for use with a bone void filler	YesRequired to mix with autograft 1:1 by volume for use with an intervertebral bodyfusion device cleared by FDA for use with a bone void filler	Not indicated for use in the intervertebral disc space
Sizes	Kits of powder and liquid components for volumes of:3 cc, 5 cc, 10 cc, and 15 cc	Kits of powder and liquid components for volumes of:3 cc, 5 cc, 10 cc, and 15 cc	Not provided in 510(k) Summary
Sterility	Provided sterile to end user	Provided sterile to end user	Not provided in 510(k) Summary
Sterilization	Gamma irradiation	Gamma irradiation	Not provided in 510(k) Summary

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Regulation Number and Section

§ 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.