(205 days)
No
The summary describes a bone putty material and its physical properties and performance in animal studies. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
The device is described as a bone putty indicated to fill bony voids or gaps in the skeletal system, and to augment provisional hardware, supporting bone fragments during surgical procedures, thus playing a direct role in the treatment and repair of the body.
No
The device description clearly states that MONTAGE is a "bone putty" used to "fill bony voids or gaps" and "augment provisional hardware." This indicates it is a therapeutic device intended for structural support or material substitution, not for diagnosing conditions.
No
The device description clearly states that MONTAGE is a material comprising two separate components that are mixed together to form a putty, indicating it is a physical substance, not software.
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." This is a therapeutic or structural purpose, not a diagnostic one.
- Device Description: The description details a material used for filling bone defects, not for analyzing biological samples to diagnose a condition.
- Performance Studies: The performance studies focus on bone formation, device resorption, and mechanical properties (drilling, temporary support), which are relevant to its use as a bone void filler, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for a structural and therapeutic purpose.
N/A
Intended Use / Indications for Use
Orthocon MONTAGE 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 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 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 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 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 MONTAGE device comprises 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 polyester-based polymers. When mixed together, the components of the MONTAGE device 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 components must be mixed immediately prior to use. MONTAGE 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:
Type: Animal study
Sample Size: Not specified, but involved a MONTAGE group, HydroSet predicate group, and empty defect negative control group.
Key Results: In a rabbit critical sized femoral defect model, at the 12-week timepoint, new bone formation averages were 16.1% in the MONTAGE group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data demonstrated that approximately 70% of implant material remained in both the MONTAGE group and the predicate group at 52 weeks following implantation. Clinical performance has not been evaluated.
Performance Data:
Type: Testing to verify mechanical properties and in vitro study.
Key Results: Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced, allowing use with provisional hardware. 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:
Type: Biocompatibility studies based on ISO 10993 recommendations.
Key Results: The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity. An assessment of Vitamin E acetate content concluded that labeling should include a Caution statement regarding monitoring patients taking Vitamin E supplements who may be at risk for bleeding.
Sterility:
Type: Sterilization validation and endotoxin testing.
Key Results: The gamma sterilization process has been validated to provide a SAL of 10-9. 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
February 3, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
Orthocon, Inc. Howard Schrayer Consultant 8 Lookout Hilton Head Island. South Carolina 29928
Re: K222063
Trade/Device Name: MONTAGE 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 1, 2022 Received: July 13, 2022
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 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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sara S. Thompson -S
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222063
Device Name MONTAGE Settable, Resorbable Bone Putty
Indications for Use (Describe)
Orthocon MONTAGE 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 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 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 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)
_ 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.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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FORM FDA 3881 (6/20)
PSC Publishing Services (301) 443-6740 EF
3
General Company Information
| Name:
Contact: | Orthocon, Inc.
Howard Schrayer
Regulatory Affairs Consultant |
|-------------------|--------------------------------------------------------------------|
| Address: | 700 Fairfield Avenue – Suite 1
Stamford, CT 06902 |
| Telephone: | (609) 273 - 7350 |
| Date Prepared: | February 3, 2023 |
General Device Information
| Product Name: | MONTAGE™ Settable, Resorbable Bone Putty |
|---|---|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | Class II |
| 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 Devices:
Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty [510(k) Number K152005]
4
K222063 Description
MONTAGE 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 MONTAGE device comprises 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 polyester-based polymers. When mixed together, the components of the MONTAGE device 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 components must be mixed immediately prior to use. MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process. The performance of MONTAGE 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 16.1% in the MONTAGE group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data demonstrated that approximately 70% of implant material remained in both the MONTAGE group and the predicate group at 52 weeks following implantation.
Intended Use (Indications)
Orthocon MONTAGE 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 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 may be used to augment provisional hardware (e.g., kwires, 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 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 as a bone void filler that can be used to augment provisional hardware (e.g., kwires, plates and screws) and to help support bone fragments during the surgical procedure.
Substantial Equivalence
This submission supports the position that Orthocon MONTAGE Settable, Resorbable Bone Putty is substantially equivalent to the HydroSet XT primary predicate 510(k) - K161447.
The following table shows comparisons of the several characteristics of MONTAGE Settable, Resorbable Bone Putty and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.
5
SUBSTANTIAL EQUIVALENCE INFORMATION
Orthocon, Inc. MONTAGE Settable, Resorbable Bone Putty
Orthovita, Inc. HydroSet XT™ Bone Void Filler
510(k) K222063
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 putty-like material | At the time of application, device is in the
form of a paste-like material |
| | |
| Device is designed to be manually applied
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 Settable, Resorbable Bone Putty
is formulated as a two-part putty/putty device
that forms a "settable" (hardening) material
when manually 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 putty-like consistency comprised of
granular calcium phosphate, (hydroxyapatite
and ß-tricalcium phosphate), calcium
stearate, vitamin E acetate, triacetin, 1,4-
butanediol 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. | 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 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. |
6
| 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 in individual and/or
multi-pack patient use sizes. | The device is available in individual; and/or
multi-pack patient use sizes. |
| | |
| Each putty is placed into a separate inner foil
"blister" which are contained within a single
outer foil pouch. The outer foil pouch
contains a desiccant. The inner blister and
outer pouch is heat sealed and sterilized.
Mixing for homogeneity takes 45 sec. | 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 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 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 16.1% in the MONTAGE group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data demonstrated approximately 70% of implant material remaining in both the MONTAGE group and the predicate group at 52 weeks following implantation. 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,
7
K222063
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, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.
The biocompatibility testing was supplemented by an assessment of the potential impact of the Vitamin E acetate content of MONTAGE. This assessment included an evaluation by CDER and concluded that labeling should include a Caution statement regarding the need to monitor patients taking Vitamin E supplements who may be at risk for bleeding.
Sterilitv
The gamma sterilization process has been validated to provide a SAL of 10-9. Each Jot of finished devices is tested for bacterial endotoxin for lot release.
Conclusions
The information provided establishes that the Orthocon MONTAGE Settable, Resorbable Bone Putty performs substantially equivalent to the predicate device for the same intended use. All results demonstrate that any differences in technology do not impact substantial equivalence.