Agilon Moldable

K193168 · Biogennix, LLC · MQV · Feb 13, 2020 · Orthopedic

Device Facts

• Record ID: K193168
• Device Name: Agilon Moldable
• Applicant: Biogennix, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Feb 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.

Device Story

Agilon Moldable is a resorbable, osteoconductive bone void filler used by surgeons to fill osseous defects. It consists of 1-2mm biphasic calcium salt granules (osteoSPAN) suspended in an organic binder containing biocompatible polymer and type I collagen. The binder facilitates intraoperative handling, shaping, and containment. Upon implantation, the polymer is rapidly absorbed, leaving the granules and collagen fibers as a scaffold to support bone growth. The device is used in clinical settings; it is applied by surgeons to fill gaps in the extremities, pelvis, or posterolateral spine. In the spine, it serves as an autograft extender. The device resorbs over time and is replaced by natural bone, aiding in the healing process.

Clinical Evidence

Bench testing and in vivo testing provided. In vivo study used a validated, single-level posterolateral spinal fusion model. Performance compared against predicate and autograft control using mechanical, histology, histomorphometry, x-ray, and micro-CT analyses. Results showed fusion rates were equivalent across all treatment groups at all time points. No adverse reactions observed; new bone formation, remodeling, and implant resorption confirmed.

Technological Characteristics

Resorbable bone void filler. Composition: 1-2mm biphasic calcium salt granules (calcium carbonate with calcium phosphate layer) and organic binder (biocompatible polymer and type I collagen). Granules are ~65% porous with ~500 micron interconnected pores. Moldable form factor. Biocompatibility evaluated per ISO 10993-1.

Indications for Use

Indicated for patients with skeletal voids or gaps in extremities, pelvis, or posterolateral spine not intrinsic to bony stability, resulting from surgery or trauma. Must be mixed with autograft for posterolateral spine use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Morpheus (K142828)

Reference Devices

• Morpheus-C (K190371)

Submission Summary (Full Text)

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February 13, 2020

Biogennix, LLC. % Elaine Duncan President Paladin Medical, Inc PO Box 560 Stillwater, Minnesota 55082

Re: K193168

Trade/Device Name: Agilon Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: November 12, 2019 Received: November 18, 2019

Dear Elaine Duncan:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laura C. Rose, PhD Acting 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) K193168

Device Name Agilon Moldable

#### Indications for Use (Describe)

Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.

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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## SUBMITTER

### Submitted on behalf of:

| Company Name: | BIOGENNIX, LLC |
|-----------------|----------------------------------------------------------------------------------------------------|
| Address: | 1641 McGaw Ave. Irvine, CA 92614 |
| Telephone: | 949-253-0094 |
| Fax: | 949-266-5800 |
| by: | Elaine Duncan, M.S.M.E., RAC President<br>Paladin Medical, Inc. PO Box 560<br>Stillwater, MN 55082 |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| Contact Person: | Elaine Duncan |
| Date Prepared: | November 12, 2019 |

## SUBJECT DEVICE

| Trade Name: | Agilon Moldable |
|--------------------|--------------------------------------------------------------|
| Common Name(s): | Bone void filler, Bone graft substitute, Bone graft extender |
| Regulation Number: | 21 CFR 888.3045 |
| Regulation Name: | Resorbable calcium salt bone void-filler device |
| Product Code: | MQV |
| Regulatory Class: | II |

## PREDICATE DEVICE

The contents of this submission have demonstrated that Agilon Moldable is substantially equivalent to Morpheus (K142828) when used as a bone graft extender in the posterolateral spine.

Morpheus-C, cleared to market as a bone graft substitute (K190371) and now marketed as Agilon Moldable, was used as a reference device.

## DEVICE DESCRIPTION

Agilon Moldable collagen enhanced bone graft substitute is a moldable, resorbable osteoconductive bone void filler composed of 1-2mm osteoSPAN granules suspended in a biocompatible orqanic binder to facilitate implant mixing, shaping, and containment. The osteoSPAN granules in the product are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin layer of calcium phosphate throuqhout its entire porosity. The orqanic binder is a combination of a biocompatible polymer and type I collagen fibers to provide enhanced intraoperative handling. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold.

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# INDICATIONS FOR USE

Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE AND REFERENCE DEVICES

Apart from the type I collagen in the subject device, the function, intended use, and technological characteristics of the subject and predicate devices are identical.

| Product | 510(k)<br>Number | Granules<br>Composition | Polymer<br>Binder | Collagen | Osteo-<br>conductive |
|---------------------------------------|------------------|------------------------------------------------------|-------------------|----------|----------------------|
| Morpheus<br>(Predicate Device) | K142828 | Calcium Carbonate/<br>Calcium Phosphate<br>composite | Yes | No | Yes |
| Agilon Moldable<br>(Reference Device) | K190371 | Identical | Identical | Yes | Yes |

# PERFORMANCE DATA

Agilon Moldable, the subject device, is IDENTICAL to reference device cleared under K190371. Biogennix followed the "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device: Guidance for Industry and FDA, June 2, 2003", and the company's design controls and risk analysis procedures to ensure the product is safe and effective for use. Biocompatibility testing and other performance characterization prescribed in "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation within a risk management process" was provided in submission K190371.

This submission includes in vivo testing results of the product in a validated, clinically relevant, single-level posterolateral spinal fusion model. Device performance was compared at multiple time points against the predicate and positive control (autograft) using mechanical, histology, histomorphometry, x-ray, and micro-CT analyses. Fusion rates were the same between all treatment groups at each time point and consistent with published literature. No adverse reactions were noted at the implant site or in distant orqans; new bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.

# CONCLUSIONS

The pre-clinical data presented in this submission demonstrate that Agilon Moldable is substantially equivalent to Morpheus when used as an autograft extender in the posterolateral spine.