Montage Flowable Settable, Resorbable Bone Paste

K231270 · Orthocon, Inc. · MQV · Sep 1, 2023 · Orthopedic

Device Facts

• Record ID: K231270
• Device Name: Montage Flowable Settable, Resorbable Bone Paste
• Applicant: Orthocon, Inc.
• Product Code: MQV · Orthopedic
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2

Intended Use

Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created or osseous defects created as the result of traumatic injury to the bone. Montage Flowable is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure. When hardened in situ, Montage Flowable may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process. Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Device Story

Montage Flowable is a sterile, resorbable bone void filler; two-part paste-like components containing granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohols, and lactide-diester/polyester-based polymers. Components mixed in static mixing tip; forms cohesive paste applied to bone voids via syringe. Material hardens in situ without significant exothermic reaction; can be drilled and tapped for provisional hardware (k-wires, plates, screws) placement. Used in clinical settings by surgeons to support bone fragments during procedures. Hardened material acts as temporary support medium; slowly resorbed and replaced by bone during remodeling. Benefits include ease of application and ability to accommodate hardware during setting.

Clinical Evidence

No human clinical data. Bench testing verified device drillability and temporary support capability. Animal study (rabbit critical-sized femoral defect model) compared Montage Flowable to HydroSet and empty control. At 12 weeks, Montage Flowable showed 15.8% new bone formation vs. 12.4% for HydroSet and 10% for control. Approximately 75% of implant material remained in both treatment groups at 12 weeks.

Technological Characteristics

Two-part paste-like material; components include granular calcium phosphate (hydroxyapatite and β-tricalcium phosphate), calcium stearate, vitamin E acetate, triglyceride, polyalcohols, and lactide-diester/polyester-based polymers. Settable via static mixing tip. Cures without significant exothermic reaction. Sterile (gamma irradiation, SAL 10^-6). Single-patient use with single-use applicator.

Indications for Use

Indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis) that are not intrinsic to the integrity of the bony structure. Used to augment provisional hardware and support bone fragments during surgical procedures. Not for structural support during healing.

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

• HydroSet XT (K161447)

Reference Devices

• HBP6, Resorbable Hemostatic Bone Paste (K193052)
• Montage-QS Settable, Resorbable Bone Putty (K191140)

Submission Summary (Full Text)

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September 1, 2023

Orthocon, Inc. Howard Schrayer Consultant 8 Lookout Hilton Head Island, South Carolina 29928

Re: K231270

Trade/Device Name: Montage Flowable Settable, Resorbable Bone Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV. OIS Dated: August 3, 2023 Received: August 3, 2023

Dear Howard Schrayer:

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

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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 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 medical devices and radiation-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,

Jesse Muir -S

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) K231270

Device Name

Montage Flowable Settable, Resorbable Bone Paste

#### Indications for Use (Describe)

Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created or osseous defects created as the result of traumatic injury to the bone. Montage Flowable is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.

When hardened in situ, Montage Flowable may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.

Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

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

# General Company Information

| Name: | Orthocon, Inc. |
|---------------|------------------------------------------------------|
| Contact: | Howard Schrayer<br>Regulatory Affairs Consultant |
| Address: | 700 Fairfield Avenue – Suite 1<br>Stamford, CT 06902 |
| Telephone: | (609) 273 - 7350 |
| Date Prepared | July 11, 2023 |

#### General Device Information

| Product Name: | Montage Flowable Settable, Resorbable Bone Paste |
|---------------|--------------------------------------------------|
|---------------|--------------------------------------------------|

Common Name: Resorbable calcium salt bone void filler device

| Classification: | Class II |
|-----------------|-----------------|
| Product code: | MQV, OIS |
| Regulation: | 21 CFR 888.3045 |

#### Predicate Devices

# Primary Predicate:

| Orthovita, Inc. | HydroSet XT™ |
|-----------------|-------------------------|
| | [510(k) Number K161447] |

# Reference Device:

- Orthocon, Inc. HBP6, Resorbable Hemostatic Bone Paste [510(k) Number K193052]
- Orthocon, Inc. Montage-QS Settable, Resorbable Bone Putty [510(k) Number K191140]

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### Description

Montage Flowable Settable. Resorbable Bone Paste is a sterile. biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The Montage Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the Montage Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process. The performance of Montage Flowable was compared to HydroSet in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 15.8% in the Montage Flowable group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data suggest that approximately 75% of implant material remained in both the Montage Flowable group and the HydroSet group at 12 weeks following implantation.

### Intended Use (Indications)

Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created or osseous defects created as the result of traumatic injury to the bone. Montage Flowable is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.

When hardened in situ, Montage Flowable may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.

Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

### Purpose of Submission

Orthocon is proposing to modify the labeling (Instructions for Use) to provide for use of Montage Flowable as a bone void filler that can be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure.

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#### Substantial Equivalence

This submission supports the position that Orthocon Montage Flowable Settable, Resorbable Bone Paste is substantially equivalent to the HydroSet XT primary predicate 510(k) - K161447.

The following table shows comparisons of the several characteristics of Montage Flowable Settable, Resorbable Bone Paste and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.

#### SUBSTANTIAL EQUIVALENCE INFORMATION

#### Orthocon, Inc. Montage Flowable Settable, Resorbable Bone Paste

Orthovita / Stryker HydroSet XT™ Bone Void Filler

TBD

510(k) - K161447

#### Similarities and Differences

| Device is indicated for use as a bone<br>graft substitute to fill voids in damaged<br>bone that are not intrinsic to the stability<br>of the bony structure. | Device is indicated for use as a bone<br>graft substitute to fill voids in damaged<br>bone that are not intrinsic to the stability<br>of the bony structure. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hardened device can be drilled and<br>tapped to provide temporary support for<br>the placement of provisional hardware<br>during the surgical procedure. | Hardened device can provide temporary<br>support for the placement of provisional<br>hardware during the surgical procedure. |
| At the time of application, device is in<br>the form of a paste-like material | At the time of application, device is in<br>the form of a paste-like material |
| Device is designed to be manually<br>applied or injected with a syringe and<br>spread onto voids in bone tissue | Device is designed to be manually<br>applied or injected with a syringe and<br>spread onto voids in bone tissue |
| Montage Flowable Settable, Resorbable<br>Bone Paste is formulated as a two-part<br>paste/paste device that forms a<br>"settable" (hardening) material when<br>mixed at the time of surgery | HydroSet XT settable, resorbable bone<br>void filler device is formulated as a two-<br>part powder/liquid device that forms a<br>"settable" (hardening) material when<br>manually mixed at the time of surgery |
| Sterile mixture of two separate<br>components of paste-like consistency<br>comprised of granular calcium<br>phosphate, (hydroxyapatite and β-<br>tricalcium phosphate), calcium stearate,<br>vitamin E acetate, a triglyceride,<br>polyalcohols and a mixture of a lactide- | Sterile mixture of two separate<br>components, a powder comprised of<br>dicalcium phosphate dihydrate,<br>tetracalcium phosphate and tri-sodium<br>citrate; and a liquid comprised of<br>sodium phosphate, polyvinylpyrrolidone<br>and water. HydroSet XT is to be |

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| diester and polyester-based polymers.<br>Montage Flowable is mixed in a static<br>mixing tip immediately prior to use.<br>Resulting settable material from the two<br>pastes is primarily comprised of calcium<br>phosphate similar to the mineral phase<br>of native bone tissue. | manually mixed immediately prior to<br>use. Resulting settable material from<br>the two components is primarily<br>comprised of calcium phosphate similar<br>to the mineral phase of native bone<br>tissue. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implanted device is resorbable in<br>greater than 30 days primarily due to<br>presence of calcium phosphate. | Implanted device is resorbable in<br>greater than 30 days primarily due to<br>presence of calcium phosphate. |
| The non-calcium salt and non-polymeric<br>components degrade via dissolution; the<br>polymer degrades via hydrolysis and<br>calcium salts degrade via chemical<br>dissolution and/or cellular removal | The non-calcium salt components<br>degrade via dissolution and calcium<br>salts degrade via chemical dissolution<br>and/or cellular removal |
| Single-patient-use device is provided<br>sterile by gamma irradiation | Single-patient-use device is provided<br>sterile by gamma irradiation and<br>ethylene oxide |
| The device is available for single-patient<br>use with a single-use applicator. | The device is available for single-patient<br>use with a single-use applicator. |
| The paste is provided in a dual-barrel<br>cartridge within a single outer foil pouch.<br>The outer foil pouch contains a<br>desiccant. The pouch is heat sealed<br>and sterilized. | Each kit contains one liquid-filled glass<br>syringe and one plastic bowl of powder<br>packaged within a double pre-formed<br>tray with a Tyvek lid. |
| Mixing for homogeneity is immediate. | Mixing for homogeneity takes 45 sec. |
| Material is settable within 10 minutes of<br>application | Material is settable within 10 minutes of<br>application |
| Device cures with no appreciable<br>exothermic reaction. | Device cures with no appreciable<br>exothermic reaction |

# Testing Completed

### Performance Animal Testing

The performance of Montage Flowable was compared to HydroSet in a rabbit critical sized femoral defect model. Micro-CT and histopathology/histomorphometry assessments were performed on defects treated with each material to quantify device resorption and new bone formation. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 15.8% in the Montage Flowable group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Clinical performance has not been evaluated.

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# Performance Data

Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. This allows use in conjunction with provisional hardware. In addition, an in vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished.

# Biocompatibility Testing

Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.

#### Sterility

The gamma sterilization process has been validated to provide a SAL of 10-6, Each lot of finished devices is tested for bacterial endotoxin for lot release.

#### Conclusions

The information provided establishes that the Orthocon Montage Flowable Settable, Resorbable Bone Paste performs substantially equivalent to the HydroSet predicate device for the same intended use. All results demonstrate that any differences in technology do not impact substantial equivalence.