(108 days)
No
The device description and performance studies focus on the material composition and biological function of a bone void filler, with no mention of AI or ML algorithms for analysis, prediction, or control.
Yes
MagnetOs Granules is intended to fill bony voids or gaps and helps in the regeneration of bone, indicating a therapeutic purpose.
No
This device is a synthetic, resorbable, osteoconductive bone void filler intended to fill bony voids or gaps; it is not designed to diagnose conditions.
No
The device description clearly states that MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler consisting of physical granules (TCP and HA). It is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that MagnetOs Granules is an "implant intended to fill bony voids or gaps of the skeletal system." This describes a device that is surgically placed within the body to treat a physical condition.
- Device Description: The description details the material composition and physical structure of the granules, emphasizing their role in bone regeneration in situ.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a disease or condition. IVDs are designed for laboratory or point-of-care testing.
This device is a surgical implant used for bone repair, not a diagnostic tool.
N/A
Intended Use / Indications for Use
MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. These 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. MagnetOs Granules resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Granules consists of 65-75% tri-calcium phosphate (TCP -Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)c(OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. MagnetOs Granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Granules is a ready-to-use product. MagnetOs Granules is provided in vials in a range of product volumes. MagnetOs Granules is gamma-sterilized and sterile packaged for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system, i.e., the extremities, pelvis 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
Bench testing data including analytical characterization, chemical composition, physical properties and animal functional study were conducted for the subject MagnetOs Granules and the predicate devices. The MagnetOs Granules met the acceptance criteria for Bacterial endotoxins test (BET)) Limulus amebocyte lysate (LAL) and passed the Materials-Mediated Pyrogenicity Rabbit study and is marketed as "Non-Pyrogenic".
MagnetOs Granules was clinically evaluated In addition. in instrumented posterolateral fusion in a randomized non-inferiority, multicenter, thoracolumbar observer blinded, intra-patient-controlled trial. The objective of the study was to evaluate whether MagnetOs Granules used alone as a bone void filler is non-inferior to autologous bone graft (iliac crest + local bone) in instrumented posterolateral fusion by means of an intra-patient model where each patient received MagnetOs Granules on one side of the posterolateral fusion and autograft on the other side of the posterolateral fusion. The clinical evidence from this randomized and intra-patient controlled trial demonstrates the non-inferiority of MagnetOs Granules versus autologous bone graft in instrumented posterolateral spinal fusion.
To support the performance of the MagnetOs Granules in combination with blood and BMA, a critical sized femoral defect rabbit model was conducted on the MagnetOs Granules alone, MagnetOs Granules combined with BMA, and MagnetOs Granules combined with blood to demonstrate substantial equivalence performance with the predicates MagnetOs Putty (K181958), and Actifuse Bone graft Substitute (K082575).
Key Metrics
Not Found
Predicate Device(s)
NuVasive AttraX Putty (K191974), MagnetOs Granules (K161859), MagnetOs Putty (K181958), Actifuse Bone graft Substitute (K082575), Synthes ChronOS (K043045)
Reference Device(s)
Not Found
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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January 10, 2022
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kuros Biosciences B.V. % Mehdi Kazemzadeh-Narbat Associate Director, Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K213111
Trade/Device Name: MagnetOs granules Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: December 9, 2021 Received: December 9, 2021
Dear Mehdi Kazemzadeh-Narbat:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MagnetOs Granules
Indications for Use (Describe)
Magnet Os Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. These 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. MagnetOs Granules 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) |
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Kuros Biosciences. The logo consists of a circular graphic on the left and the company name on the right. The graphic is made up of three teardrop shapes in green, blue, and yellow, arranged in a circular pattern. The text "Kuros Biosciences" is written in a dark gray sans-serif font.
510(k) Summary
| Device Trade Name: | MagnetOs Granules |
|---|---|
| Manufacturer: | Kuros Biosciences B.V. |
| Prof. Bronkhorstlaan 10, building 48, | |
| 3723 MB Bilthoven, The Netherlands | |
| Contact: | Sonja van der Meer, BSc |
| Regulatory Affairs Expert | |
| +31 (0)30 229 7280 | |
| Prepared by: | Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA |
| Associate Director, Regulatory Affairs, | |
| MCRA, LLC | |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Office: 202.552.6011 | |
| mkazemzadeh@mcra.com | |
| Date Prepared: | January 10, 2022 |
| Classifications: | Resorbable calcium salt bone void filler device |
| Class: | 21 CFR 888.3045, Class II |
| Product Code: | MQV |
| Primary Predicate: | NuVasive AttraX Putty (K191974) |
| Additional Predicates: | MagnetOs Granules (K161859) |
| MagnetOs Putty (K181958) | |
| Actifuse Bone graft Substitute (K082575) | |
| Synthes ChronOS (K043045) |
4
Image /page/4/Picture/1 description: The image contains the logo for Kuros Biosciences. The logo consists of a stylized, abstract shape composed of three teardrop-like elements in green, blue, and yellow. To the right of the logo is the company name, "Kuros Biosciences," in a simple, sans-serif font. The text is dark gray.
Indications For Use:
MagnetOs Granules is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis and posterolateral spine. MagnetOs Granules may be used standalone or mixed with autograft, blood, and/or bone marrow. These 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. MagnetOs Granules resorbs and is replaced with bone during the healing process.
Device Description:
MagnetOs Granules is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Granules consists of 65-75% tri-calcium phosphate (TCP -Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)c(OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. MagnetOs Granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted. New bone will be deposited on the surface of the graft when placed next to viable host bone. The graft resorbs and is replaced by bone during the natural process of bone remodeling. MagnetOs Granules is a ready-to-use product. MagnetOs Granules is provided in vials in a range of product volumes. MagnetOs Granules is gamma-sterilized and sterile packaged for single use only.
Predicate Devices:
Kuros Biosciences submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical devices, MagnetOs Granules 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 (K191974) |
|---|---|
| Additional Predicates: | MagnetOs Granules (K161859) |
| MagnetOs Putty (K181958) | |
| Actifuse Bone graft Substitute (K082575) |
Performance Testing Summary:
Bench testing data including analytical characterization, chemical composition, physical properties and animal functional study were conducted for the subject MagnetOs Granules and the predicate devices. The results of the study demonstrate substantial equivalence to the predicate devices.
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Image /page/5/Picture/1 description: The image shows the logo for Kuros Biosciences. The logo consists of a three-leaf clover-like symbol in green, blue, and yellow, followed by the company name "Kuros Biosciences" in a dark gray serif font. The logo is simple and modern, and the colors are bright and cheerful.
The MagnetOs Granules met the acceptance criteria for Bacterial endotoxins test (BET)) Limulus amebocyte lysate (LAL) and passed the Materials-Mediated Pyrogenicity Rabbit study and is marketed as "Non-Pyrogenic".
MagnetOs Granules was clinically evaluated In addition. in instrumented posterolateral fusion in a randomized non-inferiority, multicenter, thoracolumbar observer blinded, intra-patient-controlled trial. The objective of the study was to evaluate whether MagnetOs Granules used alone as a bone void filler is non-inferior to autologous bone graft (iliac crest + local bone) in instrumented posterolateral fusion by means of an intra-patient model where each patient received MagnetOs Granules on one side of the posterolateral fusion and autograft on the other side of the posterolateral fusion. The clinical evidence from this randomized and intra-patient controlled trial demonstrates the non-inferiority of MagnetOs Granules versus autologous bone graft in instrumented posterolateral spinal fusion.
Substantial Equivalence:
The subject device and primary predicate device NuVasive AttraX Putty (K191974) have the same intended use, the same product classification and product code (MQV) and have similar Indications for Use.
The subject device MagnetOs Granules is identical to the cleared predicate MagnetOs Granules (K161859) in technological characteristics including materials, manufacturing process, with similar indications for use, the biological evaluation conducted for the predicate MagnetOs Granules (K161859) is applicable to the subject device and there is no need for further biocompatibility testing.
Similar to K161859, the subject device is categorized as direct-patient contact with bone/ tissue for permanent duration (>30 days). Since the subject device is identical to the predicate device
The modifications between the subject device and K161859 is limited to the expansion of Indications for Use of the MagnetOs Granules to include possibility of stand-alone use in extremities, pelvis, and posterolateral spine.
To support the performance of the MagnetOs Granules in combination with blood and BMA, a critical sized femoral defect rabbit model was conducted on the MagnetOs Granules alone, MagnetOs Granules combined with BMA, and MagnetOs Granules combined with blood to demonstrate substantial equivalence performance with the predicates MagnetOs Putty (K181958), and Actifuse Bone graft Substitute (K082575).
Conclusion:
The subject device and the predicate devices have intended use, have similar technological characteristics, manufacturing process, and are made of similar materials. The subject and predicate devices are packaged in similar materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. MagnetOs Granules is as safe, as effective, and performs as well as, or better, than the predicate devices.