(54 days)
No
The device description and intended use focus on the material composition and physical properties of a bone void filler. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
Explanation: The device is intended to fill bony voids or gaps of the skeletal system and is replaced by bone during the healing process, which qualifies it as a therapeutic device aimed at treating or alleviating a medical condition.
No
This device is a bone void filler intended for structural support and bone regeneration, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product composed of collagen, hydroxyapatite, and tricalcium phosphate ceramic, intended to fill bony voids. It is a resorbable bone void filler, not a software application.
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 MagnetOs Flex Matrix is a bone void filler for surgical procedures to fill bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition of the material (collagen, hydroxyapatite, tricalcium phosphate) and its physical properties (porous sponge matrix, moldable). This aligns with a material intended for implantation and structural support, not for analyzing samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening. The device is directly applied to the patient's bone.
In summary, MagnetOs Flex Matrix is a medical device used in surgical procedures for bone repair and fusion, which falls under the category of therapeutic or structural devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in intervertebral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler for the repair of bony defects. The product is biocompatible.
MagnetOs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and Btricalcium phosphate ceramic (92.5-95.5 wt% MagnetOs Granules and 4.5-7.5 wt% collagen). The ceramic portion of MagnetOs Flex Matrix consists of 75-65% B-Tri-Calcium Phosphate and 25-35% Hydroxyapatite. The collagen is produced of highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The components are mixed in a slurry and lyophilized, which results in a highly porous sponge matrix that provides cohesion between the MagnetOs Granules without inhibiting the granule surface structure.
MagnetOs Flex Matrix is a ready-to-use product. Upon hydration, the material is moldable and allows users to shape MagnetOs Flex Matrix to conform to the contours of bony defects. MagnetOs Flex Matrix is supplied as a ready-to-use strip, it is sterile packaged and gammasterilized for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, intervertebral disc space, and posterolateral spine
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)
Non-clinical testing data were submitted according to the guidance documents Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (issued June 2003) and Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 2016). The non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included physical properties, sterilization, product shelf life, and biocompatibility.
Animal testing was performed in a rabbit posterolateral fusion model to demonstrate substantial equivalence to a legally marketed predicate device.
In-vitro studies showed that MagnetOs Flex Matrix induced the growth of a bone-like apatite layer on the surface of the MagnetOs Granules component following exposure to simulated body fluid.
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.
NuVasive AttraX Putty (K203714)
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.
MagnetOs Flex Matrix (K213959)
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
November 21, 2023
Image /page/0/Picture/1 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.
Kuros Biosciences B.V. Hen Baron Regulatory Affairs Manager Prof. Bronkhorstlaan 10, building 48 Bilthoven. 3723MB Netherlands
Re: K233245
Trade/Device Name: MagnetOs Flex Matrix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 28, 2023 Received: September 28, 2023
Dear Hen Baron:
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 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,
Digitally signed by Jesse Jesse Muir -S Date: 2023.11.21 14:45:33 -05'00 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
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
MagnetOs Flex Matrix
Indications for Use (Describe)
MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MaqnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in intervertebral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Flex Matrix resorbs and is replaced with bone during the healing 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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4
Image /page/4/Picture/0 description: The image shows the logo for Kuros Biosciences. The logo consists of a three-part circular design in green, blue, and gold. Below the logo, the text "Kuros Biosciences" is written in a blue font, with "Kuros" in a darker shade of blue than "Biosciences."
510(k) Summary
| Trae Name: | MagnetOs Flex Matrix |
|---|---|
| Manufacturer: | Kuros Biosciences B.V. |
| Prof. Bronkhorstlaan 10, building 48, | |
| 3723 MB Bilthoven, The Netherlands | |
| +31 (0)30 229 7280 | |
| Contact: | Hen Baron, MSc |
| Regulatory Affairs Manager | |
| Prof. Bronkhorstlaan 10, building 48, 3723 MB Bilthoven, The | |
| Netherlands | |
| Office: +31 (0)30 229 7280 | |
| hen.baron@kurosbio.com | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | November 20th, 2023 |
| Classifications: | 21 CFR 888.3045 |
| Class: | II |
| Product Codes: | MQV |
| Primary Predicate: | NuVasive AttraX Putty (K203714) |
| Additional Predicate: | MagnetOs Flex Matrix (K213959) |
Indications For Use:
MagnetOs Flex Matrix is intended to fill bony voids or gaps of the skeletal system, i.e., the intervertebral disc space, and posterolateral spine. The osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the intervertebral disc space and posterolateral spine, MagnetOs Flex Matrix must be hydrated with bone marrow aspirate (BMA) and used as an extender to autograft bone. When used in interverterbral body fusion procedures, MagnetOs Flex Matrix must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
5
Image /page/5/Picture/0 description: The image shows the logo for Kuros Biosciences. The logo consists of a three-part circular design in green, blue, and yellow. Below the logo, the company name "Kuros Biosciences" is written in two lines, with "Kuros" in a darker blue and "Biosciences" in a lighter gray.
MagnetOs Flex Matrix resorbs and is replaced with bone during the healing process.
Device Description:
MagnetOs Flex Matrix is a resorbable, osteoconductive bone void filler for the repair of bony defects. The product is biocompatible.
MagnetOs Flex Matrix is a mixture of medical grade collagen and hydroxyapatite and Btricalcium phosphate ceramic (92.5-95.5 wt% MagnetOs Granules and 4.5-7.5 wt% collagen). The ceramic portion of MagnetOs Flex Matrix consists of 75-65% B-Tri-Calcium Phosphate and 25-35% Hydroxyapatite. The collagen is produced of highly purified bioresorbable bovine split skin and consists mainly of collagen type I. The components are mixed in a slurry and lyophilized, which results in a highly porous sponge matrix that provides cohesion between the MagnetOs Granules without inhibiting the granule surface structure.
MagnetOs Flex Matrix is a ready-to-use product. Upon hydration, the material is moldable and allows users to shape MagnetOs Flex Matrix to conform to the contours of bony defects. MagnetOs Flex Matrix is supplied as a ready-to-use strip, it is sterile packaged and gammasterilized for single patient use only.
Predicate Device:
Kuros submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, MagnetOs Flex Matrix is substantially equivalent in indications, design principles, and performance to the following predicate devices, which have been determined by FDA to be substantially equivalent to preamendment devices:
Primary Predicate: NuVasive AttraX Putty (K203714) Reference Device: MagnetOs Flex Matrix (K213959)
Performance Testing Summary:
The purpose of this submission is to expand the indications for use of the MagnetOs Flex Matrix device to include use in the intervertebral disc space in conjunction with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
In support of the prior clearance (K213959), non-clinical testing data were submitted according to the guidance documents Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device (issued June 2003) and Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 2016). The non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included physical properties, sterilization, product shelf life, and biocompatibility.
6
Animal testing was performed in a rabbit posterolateral fusion model to demonstrate substantial equivalence to a legally marketed predicate device.
In-vitro studies showed that MagnetOs Flex Matrix induced the growth of a bone-like apatite layer on the surface of the MagnetOs Granules component following exposure to simulated body fluid.
The performance testing and supporting rationale are further detailed in the "Performance Testing" Section of the subject submission.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the NuVasive AttraX Putty (K203714) primary predicate device with respect to indications, design principles, and performance.
The subject device and primary predicate device both perform their intended use via calcium phosphate materials and are provided in multiple dosages. The subject and primary predicate devices are provided sterile and are intended for single-patient and single-use.
The subject device is identical to the reference device (MagnetOs Flex Matrix, K213959). The performance of the reference device has previously been assessed at the time of prior clearance.
Non-clinical testing data and animal testing data, supplemented with a clinical rationale, are referenced to demonstrate the performance of the subject device is substantially equivalent to that of the predicate device.
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues or concerns of safety or efficacy.
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. MagnetOs Flex Matrix is as safe, as effective, and performs as well as, or better, than the predicate devices.