(122 days)
No
The document describes a bone paste material and its physical properties and performance in animal studies. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a therapeutic device because its intended use is to fill bony voids or gaps in the skeletal system and to augment provisional hardware, providing a direct physical intervention for treatment.
No
Explanation: The device is a bone paste used to fill bony voids or gaps; it does not diagnose medical conditions.
No
The device is a bone paste, which is a physical material intended to fill bony voids. The description details its composition and physical properties, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "fill bony voids or gaps in the skeletal system" and to "augment provisional hardware." This describes a surgical implant or bone graft substitute, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details the composition of a bone paste material, not reagents, instruments, or systems intended for in vitro diagnostic procedures.
- Performance Studies: The performance studies focus on bone formation, device resorption, and mechanical properties (drilling and temporary support), which are relevant to a bone graft substitute, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is a medical device used in surgical procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV, OIS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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."
3
510(k) SUMMARY
General Company Information
| Name: | Orthocon, Inc. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 700 Fairfield Avenue – Suite 1 |
| 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]
4
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.
5
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
graft substitute to fill voids in damaged
bone that are not intrinsic to the stability
of the bony structure. | Device is indicated for use as a bone
graft substitute to fill voids in damaged
bone that are not intrinsic to the stability
of the bony structure. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hardened device can be drilled and
tapped to provide temporary support for
the placement of provisional hardware
during the surgical procedure. | Hardened device can provide temporary
support for the placement of provisional
hardware during the surgical procedure. |
| At the time of application, device is in
the form of a paste-like material | At the time of application, device is in
the form of a paste-like material |
| Device is designed to be manually
applied or injected with a syringe and
spread onto voids in bone tissue | Device is designed to be manually
applied or injected with a syringe and
spread onto voids in bone tissue |
| Montage Flowable Settable, Resorbable
Bone Paste is formulated as a two-part
paste/paste device that forms a
"settable" (hardening) material when
mixed at the time of surgery | HydroSet XT settable, resorbable bone
void filler device is formulated as a two-
part powder/liquid device that forms a
"settable" (hardening) material when
manually mixed at the time of surgery |
| Sterile mixture of two separate
components of paste-like consistency
comprised of granular calcium
phosphate, (hydroxyapatite and β-
tricalcium phosphate), calcium stearate,
vitamin E acetate, a triglyceride,
polyalcohols and a mixture of a lactide- | Sterile mixture of two separate
components, a powder comprised of
dicalcium phosphate dihydrate,
tetracalcium phosphate and tri-sodium
citrate; and a liquid comprised of
sodium phosphate, polyvinylpyrrolidone
and water. HydroSet XT is to be |
6
| diester and polyester-based polymers.
Montage Flowable is mixed in a static
mixing tip immediately prior to use.
Resulting settable material from the two
pastes is primarily comprised of calcium
phosphate similar to the mineral phase
of native bone tissue. | manually mixed immediately prior to
use. Resulting settable material from
the two components is primarily
comprised of calcium phosphate similar
to the mineral phase of native bone
tissue. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implanted device is resorbable in
greater than 30 days primarily due to
presence of calcium phosphate. | Implanted device is resorbable in
greater than 30 days primarily due to
presence of calcium phosphate. |
| The non-calcium salt and non-polymeric
components degrade via dissolution; the
polymer degrades via hydrolysis and
calcium salts degrade via chemical
dissolution and/or cellular removal | The non-calcium salt components
degrade via dissolution and calcium
salts degrade via chemical dissolution
and/or cellular removal |
| Single-patient-use device is provided
sterile by gamma irradiation | Single-patient-use device is provided
sterile by gamma irradiation and
ethylene oxide |
| The device is available for single-patient
use with a single-use applicator. | The device is available for single-patient
use with a single-use applicator. |
| The paste is provided in a dual-barrel
cartridge within a single outer foil pouch.
The outer foil pouch contains a
desiccant. The pouch is heat sealed
and sterilized. | Each kit contains one liquid-filled glass
syringe and one plastic bowl of powder
packaged within a double pre-formed
tray with a Tyvek lid. |
| Mixing for homogeneity is immediate. | Mixing for homogeneity takes 45 sec. |
| Material is settable within 10 minutes of
application | Material is settable within 10 minutes of
application |
| Device cures with no appreciable
exothermic reaction. | Device cures with no appreciable
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.
7
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.