(289 days)
No
The device description and performance studies focus on the material properties and biological interactions of a bone putty, with no mention of computational analysis, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated to fill bony voids or gaps in the skeletal system and is used to augment provisional hardware, which directly contributes to the treatment and healing process of bone defects.
No.
The device, Orthocon Montage-XT Settable, Resorbable Bone Putty, is a bone void filler intended to fill bony voids or gaps and acts as a temporary support medium. It does not perform any diagnostic function.
No
The device description clearly states it is a physical material (putty) composed of various chemical components, intended for filling bony voids. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fill bony voids or gaps in the skeletal system and to augment provisional hardware during surgical procedures. This is a therapeutic and structural application within the body.
- Device Description: The device is a material that is mixed and applied directly to bone defects. It hardens in situ and provides temporary support.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant/material used for structural support and filling defects, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
Orthocon Montage-XT Settable, Resorbable Bone Putty 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-XT 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-XT 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 putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Product codes
MQV, OIS
Device Description
Montage-XT Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The single use Montage-XT device contains two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of Montage-XT form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes.
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
Animal Testing included animal studies to quantify device resorption and new bone formation of Montage and Montage-XT in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 20.4% in the Montage-XT group, 20.8% in the Montage predicate group, and less than 10% in the empty defect negative control group. Animal study data show that approximately 70% of implant material remained in both the Montage-XT group and the Montage group at 12 weeks following implantation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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August 21, 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthocon, Inc. Howard Schrayer Regulatory Consultant 700 Fairfield Ave. - Suite 1 Stamford, Connecticut 06902
Re: K233566
Trade/Device Name: Montage-XT Settable, Resorbable Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV, OIS Dated: July 3, 2024 Received: July 3, 2024
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 (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, JESSE MUIR Digitally signed by JESSE
MUIR-S Date: 2024.08.21 -2 10:28:43 -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
2
K233566 - Howard Schrayer
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Montage-XT Settable, Resorbable Bone Putty
Indications for Use (Describe)
Orthocon Montage-XT Settable, Resorbable Bone Putty 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-XT 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-XT 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 putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary K233566
| Contact: | Howard Schrayer
Orthocon, Inc.
8 Lookout
Hilton Head Island, SC 29928
Telephone: 609-273-7350
hs.ss@lucidmedical.net |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 20, 2024 |
| Device Trade Name: | MONTAGE-XT™ Settable, Resorbable Bone Putty |
| Manufacturer: | Orthocon, Inc.
700 Fairfield Avenue, Suite 1
Stamford, CT 10533 |
| Telephone: | (855) 475 - 9175 |
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | Class II |
| Product Code: | MQV, OIS |
| Primary Predicate Device: | |
- MONTAGE® Settable, Resorbable Bone Putty Orthocon, Inc. 510(k) K222063
Reference Predicate Device:
- MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty Orthocon, Inc. 510(k) K220315
Indications for Use:
Orthocon Montage-XT Settable, Resorbable Bone Putty 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-XT 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-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the
5
surqical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Device Description:
Montage-XT Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The single use Montage-XT device contains two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of Montage-XT form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes. The performance of Montage-XT was compared to Montage in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 20.4% in the Montage-XT group, 20.8% in the Montage predicate group, and less than 10% in the empty defect negative control group. Animal study data show that approximately 70% of implant material remained in both the Montage-XT group and the Montage group at 12 weeks following implantation.
Purpose of this Submission:
Montage-XT was previously cleared for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The purpose of this submission is to add an indication for Montage-XT for use as a bone void filler device.
Substantial Equivalence and Predicate Devices:
The subject device is nearly identical to and is substantially equivalent to its previously cleared primary predicate, Montage. The only difference between the subject device and its reference predicate is the addition of a statement regarding the use of the device as a bone void filler.
The following table shows comparisons of the several characteristics of Montage-XT and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.
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SUBSTANTIAL EQUIVALENCE INFORMATION
Orthocon, Inc. Montage-XT Settable, Resorbable Bone Putty
Orthocon, Inc. Montage Settable, Resorbable Bone Putty
510(k) - 233566
510(k) - K222063
Similarities and Differences
| Orthocon Montage-XT Settable, | Orthocon Montage Settable, |
|---|---|
| Resorbable Bone Putty is indicated to | Resorbable Bone Putty is indicated to |
| fill bony voids or gaps in the skeletal | fill bony voids or gaps in the skeletal |
| system (i.e., extremities and pelvis). | system (i.e., extremities and pelvis). |
| These defects may be surgically | These defects may be surgically |
| created, or osseous defects created | created, or osseous defects created |
| as the result of traumatic injury to the | as the result of traumatic injury to the |
| bone. Montage-XT is indicated only | bone. Montage is indicated only for |
| for filling bony voids or gaps that are | filling bony voids or gaps that are not |
| not intrinsic to the integrity of the bony | intrinsic to the integrity of the bony |
| structure. | structure. |
| When hardened in situ, Montage-XT | When hardened in situ, Montage may |
| may be used to augment provisional | be used to augment provisional |
| hardware (e.g., k-wires, plates and | hardware (e.g., k-wires, plates and |
| screws) and to help support bone | screws) and to help support bone |
| fragments during the surgical | fragments during the surgical |
| procedure. The hardened putty acts | procedure. The hardened putty acts |
| only as a temporary support medium | only as a temporary support medium |
| and is not intended to provide | and is not intended to provide |
| structural support during the healing | structural support during the healing |
| process. | process. |
| Montage-XT can be drilled and | |
| tapped, and hardware can be placed | |
| through it at any time during the | |
| setting process. | Montage can be drilled and tapped, |
| and hardware can be placed through it | |
| at any time during the setting process. | |
|
|
| At the time of application, device is in | At the time of application, device is in |
| the form of a putty-like material | the form of a putty-like material |
|
|
|
| Device is designed to be manually | Device is designed to be manually |
| applied and spread onto bone defects | applied and spread onto bone defects |
|
|
|
| Montage-XT Settable, Resorbable
Bone Putty is formulated as a two-
part putty/putty device that forms a
"settable" (hardening) material when
mixed at the time of surgery | Montage-XT Settable, Bone Putty is
formulated as a two-part putty/putty
device that forms a "settable"
(hardening) material when mixed at
the time of surgery |
| Sterile mixture of two separate | Sterile mixture of two separate |
| components of putty-like consistency
comprised of granular calcium
phosphate, (hydroxyapatite and ß-
tricalcium phosphate), calcium
stearate, vitamin E acetate, a
triglyceride, a polyalcohol and a
mixture of a lactide-diester and
polyester-based (lactide and
caprolactone) absorbable polymers.
Montage-XT is to be mixed
immediately prior to use. Resulting
settable material from the two putties
is primarily comprised of calcium
phosphate similar to the mineral | components of putty-like consistency
comprised of granular calcium
phosphate, (hydroxyapatite and ß-
tricalcium phosphate), calcium
stearate, vitamin E acetate, a
triglyceride, a polyalcohol and a
mixture of a lactide-diester and
polyester-based (lactide and
caprolactone) absorbable polymers.
Montage is to be mixed immediately
prior to use. Resulting settable
material from the two putties is
primarily comprised of calcium
phosphate similar to the mineral |
| phase of native bone tissue. | phase of native bone tissue. |
| Implanted device is resorbable in | Implanted device is resorbable in |
| greater than 30 days primarily due to
presence of calcium phosphate. | 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 and non-
polymeric components degrade via
dissolution; the polymer degrades via
hydrolysis 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 |
| The two putties are provided | The two putties are provided |
| separately within a single outer foil
pouch. The outer foil pouch contains
a desiccant. | separately within a single outer foil
pouch. The outer foil pouch contains
a desiccant. |
| Mixing for homogeneity takes 45 sec. | Mixing for homogeneity takes 45 sec. |
| Working time is 4 minutes | |
| | Working time is 2 minutes |
| Device cures with no appreciable | Device cures with no appreciable |
| exothermic reaction. | exothermic reaction |
| Device can be drilled and tapped, and | Device can be drilled and tapped, and |
| hardware can be placed through it at | hardware can be placed through it at |
| any time during the setting process. | any time during the setting process. |
| When hardened in situ, Montage-XT | When hardened in situ, Montage-XT may |
| may be used to augment provisional | be used to augment provisional |
| hardware (e.g., k-wires, plates and | hardware (e.g., k-wires, plates and |
| screws) and to help support bone | screws) and to help support bone |
| fragments during the surgical | fragments during the surgical |
| procedure. The hardened putty acts | procedure. The hardened putty acts |
| only as a temporary support medium | only as a temporary support medium |
| and is not intended to provide | and is not intended to provide |
| structural support during the healing | structural support during the healing |
| process. | process. |
7
8
Technoloqical Characteristics:
The technological characteristics of the devices are unchanged. The only change is the addition of a statement regarding the use of Montage-XT in as a bone void filler.
Performance Testing:
The only clinically meaningful difference between Montage and Montaqe-XT is the extension of working time from 2 to 4 minutes. Evaluations were previously conducted to compare MONTAGE-XT Settable, Resorbable Bone Putty with the predicate device. The evaluations demonstrated that Montage-XT is substantially equivalent to the Montage predicate in intended use, technological characteristics, and performance. This testing included the following:
Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance. The following bench studies were completed: pH characterization, dissolution/solubility, reaction temperature, relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility and working time. Both devices are sterilized with the same validated gamma irradiation process and both have the same established shelf-life / stability characteristics.
Biocompatibility Testing was conducted to evaluate biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
9
Animal Testing included animal studies to quantify device resorption and new bone formation of Montage and Montage-XT in a rabbit critical sized femoral defect model. Because the devices have nearly identical formulations and have been found to be substantially equivalent in all other respects, the data supporting use as a bone void filler from studies of Montage is relevant to Montage-XT and was confirmed through testing of Montage-XT. Clinical performance has not been evaluated.
Conclusion
MONTAGE-XT is substantially equivalent to Montage Settable, Resorbable Bone Putty with respect to intended use, general technological characteristics, and performance.