(58 days)
No
The 510(k) summary describes a bone putty material and its physical properties and performance in animal studies. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML.
Yes
The device is described as a "bone putty" indicated to fill bony voids or gaps and acts as a "temporary support medium," which directly supports the repair and healing process of the skeletal system.
No
The device description and intended use clearly state that Orthocon Montage-QS is a bone putty indicated for filling bony voids or gaps and providing temporary support during surgical procedures; it is a therapeutic/restorative device, not one designed to diagnose conditions.
No
The device description clearly states it is a "sterile, biocompatible, resorbable material" comprising two physical components that are mixed together to form a putty. This describes a physical medical device, not a software-only one.
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 is a therapeutic and structural application within the body.
- Device Description: The description details a material that is implanted into the body and resorbed over time, being replaced by bone. This is an in-vivo application.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on bone formation, material resorption, and mechanical properties (drilling, temporary support), all of which relate to its function as a bone void filler within the body.
IVD devices are used outside the body to examine specimens from the human body. This device is used inside the body for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Orthocon Montage-QS 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-QS 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-QS 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-QS can be drilled and tapped, and hardware can be placed through it at any time during process.
Product codes
MQV
Device Description
Montage-QS 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-QS device comprises two separate components of putty-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, the components of the Montage-QS device form a cohesive putty-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-QS 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
Efficacy Evaluation: The performance of Montage-QS as a bone void filler was compared to HydroSet in a rabbit critical size 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 17.2% in the Montage-QS group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data demonstrated that approximately 75% of implant material remained in both the Montage-QS group and the predicate group at 12 weeks following implantation.
Performance Data: Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. 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, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.
Sterility: 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
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 25, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthocon, Inc. Howard Schrayer Consultant 8 Lookout Hilton Head Island, South Carolina 29928
Re: K231903
Trade/Device Name: Montage-QS 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 Dated: June 28, 2023 Received: June 28, 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 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
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) K231903
Device Name Montage-QS Settable, Resorbable Bone Putty
Indications for Use (Describe)
Orthocon Montage-QS 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-QS 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-QS 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-QS can be drilled and tapped, and hardware can be placed through it at any time during 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)
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510(k) SUMMARY (Per 21 CFR 807.92)
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 | August 24, 2023 |
| General Device Information | |
| Product Name: | Montage-QS Settable, Resorbable Bone Putty |
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | Product code: MQV |
| Regulation: | 21 CFR 888.3045 |
| Predicate Devices | |
| Primary Predicate: | |
| Orthovita, Inc. | HydroSet XT™ |
| [510(k) Number K161447] | |
| Reference Devices: | |
| Orthocon, Inc. | Montage-QS Settable, Resorbable Hemostatic Bone Putty |
| [510(k) Number K191140] | |
| Orthocon, Inc. | Montage Settable, Resorbable Bone Putty |
| [510(k) Number K222063] |
Description
Montage-QS 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-QS device comprises two separate components of putty-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, the components of the Montage-QS device form a
4
cohesive putty-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-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process. The performance of Montage-QS 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 17.2% in the Montage-QS group, 12.4% in the HydroSet proup, and 10% in the empty defect negative control group. Animal study data suggest that approximately 75% of implant material remained in both the Montage-QS group and the HydroSet group at 12 weeks following implantation.
Indications for Use
Orthocon Montage-QS 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 surqically created, or osseous defects created as the result of traumatic injury to the bone. Montage-QS 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-QS 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-QS 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-QS 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 surqical procedure.
Substantial Equivalence
This submission supports the position that Orthocon Montage-QS Settable, Resorbable Bone Putty is substantially equivalent to a number previously cleared devices, including the HydroSet referenced predicate and is exactly the same composition as the reference predicate Orthocon Montage-QS Settable, Resorbable Bone Putty [cleared under 510(k) K191140].
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SUBSTANTIAL EQUIVALENCE INFORMATION
| Orthocon, Inc.
Montage-QS Settable,
Resorbable Bone Putty | Orthocon, Inc.
Montage-QS Settable, Resorbable
Hemostatic Bone Putty | Orthovita, Inc.
HydroSet XTTM
Bone Void Filler |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) - TBD | 510(k) – K191140 | 510(k) - K161447 |
| | Comparisons | |
| 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 in the control of
bleeding from cut or damaged bone surfaces
by acting as a tamponade | 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. | Not currently cleared for use in temporary
support of provisional hardware, but exactly
the same formulation as the subject of this
510(k). | 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 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
and spread onto bleeding bone tissue | Device is designed to be manually applied
or injected with a syringe and spread onto
voids in bone tissue |
| Montage-QS 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 | Montage-QS Settable, Resorbable Bone
Putty is formulated as a two-part putty/putty
device that forms a "settable" (hardening)
hemostatic putty 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 | Sterile mixture of two separate components
of putty-like consistency comprised of | Sterile mixture of two separate components,
a powder comprised of dicalcium phosphate |
| granular calcium phosphate, (hydroxyapatite
and β-tricalcium phosphate), calcium
stearate, vitamin E acetate, a triglyceride,
polyalcohols and a mixture of a lactide-
diester and polyester-based (lactide and
caprolactone) absorbable polymers.
Montage-QS is to be mixed immediately
prior to use. Resulting settable material from
the two putties is primarily comprised (~70%
by weight) of calcium phosphate similar to
the mineral phase of native bone tissue | granular calcium phosphate, (hydroxyapatite
and β-tricalcium phosphate), calcium
stearate, vitamin E acetate, a triglyceride,
polyalcohols and a mixture of a lactide-
diester and polyester-based (lactide and
caprolactone) absorbable polymers.
Montage-QS is to be mixed immediately prior
to use. Resulting settable material from the
two putties is primarily comprised (~70% by
weight) of calcium phosphate similar to the
mineral phase of native bone tissue | 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. |
| 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. | 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 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. | Single-patient-use device is provided sterile
by gamma irradiation and ethylene oxide. |
| The bone putty is available in individual
and/or multi-pack patient use sizes. | The bone putty 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. | 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. | 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 30 sec. | Mixing for homogeneity takes 30 sec. | Mixing for homogeneity takes 45 sec. |
| Material is hardened within 5 minutes of application | Material is hardened within 5 minutes of application | Material is hardened within 10 minutes of application |
| Device hardens with no appreciable exothermic reaction. | Device hardens with no appreciable exothermic reaction. | Device hardens with no appreciable exothermic reaction |
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7
The differences described in the table above do not impact substantial equivalence.
8
Testing Completed
Efficacy Evaluation
The performance of Montage-QS as a bone void filler was compared to HydroSet in a rabbit critical size 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 17.2% in the Montage-QS group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data demonstrated that approximately 75% of implant material remained in both the Montage-QS group and the predicate group at 12 weeks following implantation.
Performance Data
Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. 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, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.
Sterility
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.
Conclusions
The information provided establishes that the Orthocon Montage-QS 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.