Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware and intervertebral disc space. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

When used in the intervertebral disc space, Actifuse must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). ALTAPORE can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE SHAPE:

ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space. ALTAPORE SHAPE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE MIS: ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE MIS can be used by itself, with autograft as a bone graft extender or with autogenous bone marrow aspirate. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE MIS resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE MIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Device Description

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS

Actifuse is a phase-pure, porous, silicate-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse is similar to human cancellous bone. After it is implanted, ACTIFUSE undergoes physiologically-mediated resorption and is replaced by natural bone

ACTIFUSE is osteostimulatory based upon in vitro studies that show cellular responses, such as metabolic activity and proliferation, are accelerated when compared to an identical that did not contain 0.8% silicon by weight..

ACTIFUSE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ACTIFUSE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses.

The Actifuse bone void filler is presented in multiple product variants:

ACTIFUSE ABX

ACTIFUSE ABX presents the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable aqueous gel carrier packaged in a wide-bore applicator. ACTIFUSE ABX is a sterile, single-use device available in volumes of 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml.

ACTIFUSE ABX is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood, autologous bone marrow aspirate, or autologous bone at the discretion of the surgeon.

ACTIFUSE MIS

ACTIFUSE MIS System is an ACTIFUSE ABX packaging configuration in which the ACTIFUSE ABX implant material is supplied in a sterile 7.5ml cartridge packed with ACTIFUSE ABX implant material is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ACTIFUSE SHAPE

ACTIFUSE SHAPE supplies the ACTIFUSE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ACTIFUSE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ACTIFUSE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macro and micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca. P. O. H. Si).

ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available in 1.5 ml, 2.5 ml, 5 ml, 10 ml, and 20 ml configurations.

ALTAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE undergoes cell-mediated remodeling and is replaced by natural bone.

ALTAPORE MIS

ALTAPORE MIS System is an ALTAPORE packaging configuration in which the ALTAPORE implant material is supplied in a sterile 7.5ml cartridge is presented with a delivery applicator and as a separate 7.5ml refill cartridge.

ALATAPORE MIS System (hereafter referred to as "Altapore MIS) is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE MIS is bioactive based on in vitro studies that show it forms a surface apatite layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE

ALTAPORE SHAPE supplies the ALTAPORE bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler suspended in an absorbable Alkylene Oxide co-polymer carrier as a shaped wax-like putty in a sterile pouch. ALTAPORE SHAPE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip.

ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon.

ALTAPORE SHAPE is bioactive based on in vitro studies that show it forms a surface apatitelayer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect.

ALTAPORE SHAPE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. ALTAPORE SHAPE undergoes cell-mediated remodeling and is replaced by natural bone.

AI/ML Overview

The provided document describes a 510(k) premarket notification for several bone void filler devices (Actifuse ABX, Actifuse MIS, Actifuse Shape; ALTAPORE, ALTAPORE SHAPE; ALTAPORE MIS) by Baxter Healthcare Corporation. The submission aims to expand the indications for use to include intervertebral disc space applications.

Crucially, the document explicitly states that "no additional non-clinical data was needed to support the expanded indications proposed in the current submission" because "the subject device is identical to the previously cleared primary predicate device (K232315)." This means that the current submission relies entirely on the performance data of the predicate device (Catalyst Bone Void Filler, OssDsign AB, K232315) and existing reference devices (Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575; Altapore, Baxter, K192363; Altapore Shape, Baxter, K200640; Altapore MIS, Baxter, K201464).

Therefore, I cannot provide detailed acceptance criteria or study results for the currently submitted devices directly from this document, as no new performance testing specific to this submission's expanded indication for these devices is reported. The information requested below would typically come from the original 510(k) submission for the predicate device (K232315) or the reference devices.

However, I can extract the available information as specifically related to this submission's approach to demonstrating substantial equivalence.

1. A table of acceptance criteria and the reported device performance

As stated above, no new performance data or acceptance criteria are provided in this specific submission for the expanded indications. The submission argues for substantial equivalence based on the device being identical to a predicate (K232315) and similar to reference devices (K082575, K192363, K200640, K201464).

Acceptance Criteria (Implicit via Substantial Equivalence to Predicate): The device is considered to meet acceptance criteria if its technological characteristics, intended use, and performance are substantially equivalent to the cleared predicate and reference devices, implying it is as safe and effective.

Reported Device Performance:
The document describes the characteristics and prior in vitro/in vivo findings of the devices, which would have supported their initial clearances, but does not present new performance test results against new acceptance criteria for the expanded indication.

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS:
- Osteostimulatory: Based on in vitro studies showing accelerated cellular responses (metabolic activity and proliferation) compared to an identical product without 0.8% silicon by weight.
- Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
- Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses.
ALTAPORE, ALTAPORE SHAPE, ALTAPORE MIS:
- Bioactive: Based on in vitro studies showing formation of a surface apatite layer in simulated body fluid.
- Osteoconductive: Based on in vivo animal studies demonstrating bone healing in a critical defect model, confirmed by radiographic, histopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone.

The remaining points cannot be fully addressed from the provided text for this specific K-submission, as it explicitly states that no additional non-clinical data was needed. This implies that the current submission relies on previous data and FDA's prior determinations of substantial equivalence for the predicate and reference devices.

To answer points 2-9, one would need to access the original 510(k) submissions for:

Primary Predicate: Catalyst Bone Void Filler, OssDsign AB, K232315
Reference Devices:
- Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575
- Altapore, Baxter, K192363
- Altapore Shape, Baxter, K200640
- Altapore MIS, Baxter, K201464

Without those specific predicate/reference 510(k) summaries, I cannot provide the requested details regarding sample sizes, data provenance, ground truth establishment, or specific study methodologies.

Summary based on information provided for the current K241564 submission:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* N/A: No new test set data was reported as needed for this submission. Reliance on previously cleared predicate (K232315) and reference devices (K082575, K192363, K200640, K201464).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
* N/A: No new ground truth establishment reported as needed for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A: No new test set reported as needed for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
* N/A: This device is a bone void filler, not an AI/imaging device, so MRMC studies are not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* N/A: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A: No new ground truth reported as needed for this submission. However, for the original clearances of the predicate/reference devices, the descriptions mention "radiographic, histopathological, histomorphometric, and mechanical analyses" in animal studies, which serve as forms of ground truth for osteoconductivity.

8. The sample size for the training set
* N/A: This is a physical medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
* N/A: Not applicable for a physical medical device.

Summary

{0}------------------------------------------------

August 2, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Baxter Healthcare Corporation Phillip Romei Manager, Global Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, Illinois 60073

Re: K241564

Trade/Device Name: Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE: ALTAPORE MIS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: May 22, 2024 Received: May 31, 2024

Dear Phillip Romei:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

Robert M. Stefani -S 2024.08.02 09:17:50 -04'00'

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

{2}------------------------------------------------

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K241564

Device Name Actifuse ABX: Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE: ALTAPORE MIS

Indications for Use (Describe)

ACTIFUSE ABX, ACTIFUSE SHAPE and ACTIFUSE MIS:

When used in the intervertebral disc space, Actifuse must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE:

When used in the intervertebral disc space, ALTAPORE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE SHAPE:

ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, intervertebral disc space, and pelvis).

When used in the intervertebral disc space. ALTAPORE SHAPE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE MIS: ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e.,

{4}------------------------------------------------

extremities, posterolateral spine, intervertebral disc space, and pelvis).

When used in the intervertebral disc space, ALTAPORE MIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

510(k) Summary

Device Trade Name:	ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MISALTAPOREALTAPORE SHAPEALTAPORE MIS
Manufacturer:	Baxter Healthcare CorporationOne Baxter ParkwayDeerfield, Illinois 60015
Contact:	Phillip RomeiSpecialist, Regulatory Affairs25212 W. Illinois Route 120Round Lake, IL 60073
Prepared by:	Justin Eggleton, Vice President, Head of MusculoskeletalRegulatory AffairsMCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800
Date Prepared:	May 22, 2024
Classifications:	21 CFR §888.3045, Resorbable Calcium Salt Bone Void FillerDevice
Class:	II
Product Codes:	MQV
Primary Predicate:	Catalyst Bone Void Filler, OssDsign AB, K232315
Reference Devices:	Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575Altapore, Baxter, K192363Altapore Shape, Baxter, K200640Altapore MIS, Baxter, K201464

{6}------------------------------------------------

Indications For Use:

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS

When used in the intervertebral disc space, Actifuse must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE

When used in the intervertebral disc space, ALTAPORE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE SHAPE

ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis).

ALTAPORE SHAPE can be used by itself or with autograft as a bone graft extender in posterolateral spinal fusion procedures. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE SHAPE resorbs and is replaced with bone during the healing process.

When used in the intervertebral disc space, ALTAPORE SHAPE must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

ALTAPORE MIS

ALTAPORE MIS is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis).

{7}------------------------------------------------

When used in the intervertebral disc space, ALTAPORE MIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Device Description:

ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS

The Actifuse bone void filler is presented in multiple product variants:

ACTIFUSE ABX

ACTIFUSE MIS

{8}------------------------------------------------

ACTIFUSE SHAPE

ALTAPORE

ALTAPORE MIS

{9}------------------------------------------------

ALTAPORE SHAPE

Predicate Device:

Baxter submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Baxter Bone Void Fillers are substantially equivalent in intended use, indications, basic design, function, and performance to the following predicate device, which has been determined by FDA to be substantially equivalent to preamendment device:

Primary Predicate: Catalyst Bone Void Filler, OssDsign AB, K232315

Reference Device(s):

Baxter submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Baxter ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS, ALTAPORE, ALTAPORE SHAPE, and ALTAPORE MIS Bone Void Fillers are substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to pre-amendment devices:

Reference Device:	Actifuse ABX, Actifuse Shape, & Actifuse MIS, Baxter, K082575
	Altapore, Baxter, K192363
	Altapore Shape, Baxter, K200640

{10}------------------------------------------------

Altapore MIS, Baxter, K201464

Performance Testing Summary:

The purpose of this submission is to expand the indications for use of the Baxter Bone Void Filler devices to include use in the intervertebral disc space in conjunction with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Because the subject device is identical to the previously cleared primary predicate device (K232315), it was determined that no additional non-clinical data was needed to support the expanded indications proposed in the current submission.

Conclusion:

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Baxter ACTIFUSE ABX, ACTIFUSE SHAPE, ACTIFUSE MIS, ALTAPORE, ALTAPORE SHAPE, and ALTAPORE MIS Bone Void Fillers are as safe, as effective, and performs as well as the predicate devices.

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.