(136 days)
Not Found
No
The device description and performance studies focus on the material composition and biological performance of a bone void filler, with no mention of AI or ML technologies.
Yes
The device is described as an "implant intended to fill bony voids or gaps of the skeletal system," which directly addresses a medical condition (bone defects) and aims to restore bone function by promoting healing and being replaced by bone over time. This fits the definition of a therapeutic device.
No
The device is described as an implant intended to fill bony voids or gaps, acting as a bone void filler and being replaced by bone during healing. Its function is to facilitate healing and structural support, not to diagnose a condition.
No
The device description clearly states it is a synthetic, resorbable, and osteoconductive bone void filler in block form, indicating it is a physical material, 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 MagnetOs Putty is an "implant intended to fill bony voids or gaps of the skeletal system". This describes a device used in vivo (within the body) for structural support and bone regeneration.
- Device Description: The description details the composition of the implant (calcium phosphate and hydroxyapatite granules with a binder) and its form (block form, sterile packaged). This aligns with a surgical implant, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status. The purpose is to physically fill and support bone defects.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. MagnetOs Putty does not fit this description.
N/A
Intended Use / Indications for Use
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. These osseous defects may be surgically created of of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% beta-Tri-Calcium Phosphate (TCP, Саз(PO4)2) and 25-35% Hydroxyapatite (HA, Cas(PO4)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is 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 and animal data demonstrated that the safety and effectiveness of the MagnetOs putty is equivalent to the predicate devices.
Biocompatibility Testing: Biocompatibility of the device was assessed using the methodology described in ISO 10993-1, ISO10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO10993-11 and USP .
Bench Testing (non-clinical tests): Material characterization performed included the following:
- chemical composition was analyzed by x-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR), Nuclear Magnetic Resonance (NMR), Organic Volatile Impurities (OVI).
- trace elemental analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/MS).
- surface microstructure and bioactivity were evaluated by scanning electron microscopy (SEM) and in vitro surface mineralization study (following immersion in simulated body fluid (SBF)).
- physical properties including porosity by mercury intrusion porosimetry. dissolution, molecular weight by inherent viscosity (IV).
The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject MagnetOs Putty and the predicate devices.
Animal Studies: The performance of MagnetOs Putty was compared to that of the predicate devices in a posterolateral spine fusion animal model and as a stand alone bone void filler for repair of defects in a critical sized femoral animal model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate.
Key Metrics
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
December 6, 2018
Kuros Biosciences B.V. % Angela Paterson Senior Consultant Compliance Solutions Ltd. Suite 10, Dunswood House, 1 Dunswood Road, Cumbernauld Glasgow, United Kingdom, G67 3EN
Re: K181958
Trade/Device Name: MagnetOs Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: November 5, 2018 Received: November 7, 2018
Dear Ms. Paterson:
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/cdrl/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, 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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K181958
Device Name MagnetOs Putty
Indications for Use (Describe)
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, Magnet Os Patty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. These osseous defects may be surgically created of of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MagnetOs Putty 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
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510(k) Summary
This 510(k) summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
Kuros Biosciences B.V.
Submitter's Address:
Kuros Biosciences B.V. Professor Bronkhorstlaan 10, building 48 3723 MB Bilthoven The Netherlands Tel: +31 307400450
Establishment registration Number
3008147766
Contact person:
Angela Paterson
Telephone +44 (0)7884 274 220
Date prepared:
24th October 2018
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Kuros Biosciences B.V. Traditional 510 (k): For MagnetOs Putty
Device Classification Information:
| Regulation
Number | Device Name | Device Class | Product
Code | Classification
Panel |
|----------------------|---------------------------------------------------|--------------|-----------------|--------------------------------|
| 888.3045 | Resorbable
calcium salt
bone void
filler | II | MQV | Orthopedic &
Rehabilitation |
Device Trade Name:
MagnetOs Putty
Device Common Name:
MagnetOs Putty
Intended Use:
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system i.e., the extremities, pelvis and posterolateral spine. In the posterolateral spine, MagnetOs Putty must be used with autograft as bone graft extender. In extremities and pelvis, MagnetOs Putty is used alone. 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 Putty resorbs and is replaced with bone during the healing process.
Summary of substantial equivalence:
MagnetOs Putty is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
| General Information | |||
|---|---|---|---|
| Property | 510k | ||
| subject | |||
| Device | Primary | ||
| Equivalent | |||
| Device | Equivalent | ||
| Device | |||
| Device Name | MagnetOs | ||
| Putty | Actifuse | Actifuse ABX | |
| Device | |||
| Manufacturer | Kuros | ||
| Biosciences | |||
| BV | Baxter | Baxter | |
| 510k | No | K082575 | K082575 |
| Device | |||
| Classification | II | II | II |
| Product Code | MQV | MQV | MQV |
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Kuros Biosciences B.V. Traditional 510 (k): For MagnetOs Putty
| General Information | |||
|---|---|---|---|
| Property | 510k subject Device | Primary Equivalent Device | Equivalent Device |
| Use Environment | Medical/ Clinical | Medical/ Clinical | Medical/ Clinical |
The subject device MagnetOs and predicate devices Actifuse and Actifuse ABX K082575 have the same intended use, the same product classification and product code (MQV).
MagnetOs Putty is substantially equivalent to the predicate devices Actifuse and Actifuse ABX (K082575) with respect to design, structure, materials, mechanism of action, and similar Indications for Use in extremities and pelvis. Actifuse is the primary predicate device used for comparison animal studies.
Between MagnetOs Putty, Actifuse and Actifuse ABX predicate devices, the limited differences are the total porosity, ratio of beta-tricalcium phosphate: Hydroxyapatite, silicate content and the binder formulation. The LEOL binder of MagnetOs Putty has the same temporary function as the binder's predicate device Actifuse ABX (K082575). These aspects do not affect the safety and biocompatibility of MagnetOs Putty because of the identical nature of the building blocks of these materials and the site of application (bone).
Device Description
MagnetOs Putty is a synthetic, resorbable and osteoconductive bone void filler for the repair of bony defects, containing 65-75% beta-Tri-Calcium Phosphate (TCP, Саз(PO4)2) and 25-35% Hydroxyapatite (HA, Cas(PO4)3OH) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
MagnetOs Putty is gamma-sterilized, comes in several sizes in block form and is sterile packaged for single use only.
Technological Characteristics
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, and performance characteristics in accordance with FDA recognized consensus standards and FDA guidance documents as applicable.
6
Performance Data
Bench testing and animal data demonstrated that the safety and effectiveness of the MagnetOs putty is equivalent to the predicate devices. A summary is given below.
Biocompatibility Testing
Biocompatibility of the device was assessed using the methodology described in ISO 10993-1, ISO10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO10993-11 and USP .
Bench Testing (non-clinical tests)
Material characterization performed included the following:
- . chemical composition was analyzed by x-ray diffraction (XRD), and Fourier transform infrared spectroscopy (FTIR), Nuclear Magnetic Resonance (NMR), Organic Volatile Impurities (OVI)
- trace elemental analysis was performed by inductively coupled plasma/mass . spectroscopy (ICP/MS),
- surface microstructure and bioactivity were evaluated by scanning electron ● microscopy (SEM) and in vitro surface mineralization study (following immersion in simulated body fluid (SBF)), and
- physical properties including porosity by mercury intrusion porosimetry. . dissolution, molecular weight by inherent viscosity (IV).
The analytical characterization demonstrated equivalent chemical composition, physical properties and performance characteristics for the subject MagnetOs Putty and the predicate devices.
Animal Studies
The performance of MagnetOs Putty was compared to that of the predicate devices in a posterolateral spine fusion animal model and as a stand alone bone void filler for repair of defects in a critical sized femoral animal model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
7
Kuros Biosciences B.V. Traditional 510 (k): For MagnetOs Putty
Safety and effectiveness
MagnetOs Putty utilizes similar technology currently found in legally marketed predicate devices. Based on testing and comparison with the predicate devices, the MagnetOs Putty indicated no adverse indications or results. It is our determination that the MagnetOs Putty is as safe and effective as the predicate devices and performs within its design specifications and is substantially equivalent to the predicate devices.