(47 days)
No
The summary describes a bone void filler composed of synthetic materials and a polymeric binder. There is no mention of software, algorithms, data processing, or any other components typically associated with AI/ML. The focus is on the material properties and biological interaction of the implant.
Yes
The device is described as an "implant intended to fill bony voids or gaps of the skeletal system" and resorbs while being "replaced with bone during the healing process." This aligns with the definition of a therapeutic device designed to treat or alleviate a condition.
No
Explanation: The device is an implant intended to fill bony voids or gaps, acting as a bone void filler and guide for bone regeneration, not to diagnose a condition.
No
The device description clearly states that MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler composed of physical materials (TCP, HA granules, polymeric binder). It is a physical implant, 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 within the body for structural support and bone regeneration.
- Device Description: The description details the composition of the implant (TCP, HA, polymeric binder) and its function in guiding bone regeneration. It focuses on the physical and biological interaction with bone tissue in vivo.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of MagnetOs Putty does not involve any of these activities.
Therefore, MagnetOs Putty is a medical device (specifically, a bone void filler/bone graft substitute), but it does not fit the definition of an In Vitro Diagnostic device.
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, intervertebral disc space, and posterolateral spine. 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 may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Putty resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Cas(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular structure that resembles the interconnected porosity of human cancellous bone. The surface of the granules in MagnetOs Putty is covered with needle-shaped features that are submicron in size. The granules are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG.
The fast-resorbing polymeric binder in the subject device is designed to improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted.
When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling.
MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gammasterilized, comes in several sizes in block form and is sterile packaged for single use only.
MagnetOs Putty is MRI (Magnetic Resonance Imaging) Safe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the extremities, pelvis, 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, supplemented with clinical 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 analytical characterization, chemical composition, physical properties, and animal functional studies.
The subject device is categorized as direct-patient contact with bone/tissue for permanent duration (>30 days). Biocompatibility was performed in accordance with "ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
MagnetOs Putty met the acceptance criteria for the Limulus amebocyte lysate (LAL) test, gel clot method (Bacterial endotoxins test (BET)) per Ph.Eur. 2.6.14, Bacterial Endotoxins and USP , Bacterial Endotoxins. MagnetOs Putty passed the Materials-Mediated Pyrogenicity Rabbit study per USP 39-NF34 and is marketed as "Non-Pvrogenic". A sterilization validation was performed and complies with ISO 11137, "Sterilization of Sterilization of Health Care Products - Radiation", to ensure a sterility assurance level (SAL) of 10-6. Product and sterile-barrier shelf-life studies were conducted per ISO 11607, "Packaging for terminally sterilized medical devices".
In-vitro studies showed that MagnetOs Putty 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)
NuVasive Attrax Putty, NuVasive, Inc., K203714
Reference Device(s)
MagnetOs Putty, K230736
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
April 1, 2024
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 consists of a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Kuros Biosciences B.V. Hen Baron Regulatory Affairs Manager Prof. Bronkhorstlaan 10, building 48 Bilthoven. 3723MB Netherlands
Re: K240442
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: February 2, 2024 Received: February 14, 2024
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).
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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 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,
Digitally signed by Jesse Muir -S
Jesse Muir -S Date: 2024.04.01 09:18:59
-04'00'
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 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, intervertebral disc space, and posterolateral spine. 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 may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. 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)
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Image /page/4/Picture/0 description: The image shows the Kuros Biosciences logo. The logo consists of a three-part circular design in green, blue, and yellow, followed by the company name "Kuros Biosciences" in a simple, sans-serif font. The logo is clean and professional, suggesting a company focused on science and innovation.
510(k) Summary
| Trade Name: | MagnetOs Putty |
|---|---|
| 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: | March 20, 2024 |
| Classifications: | 21 CFR 888.3045 |
| Class: | II |
| Product Codes: | MQV |
| Primary Predicate: | NuVasive Attrax Putty, NuVasive, Inc., K203714 |
| Additional Predicate: | MagnetOs Putty, Kuros Biosciences B.V, K230736 |
Indications For Use:
MagnetOs Putty is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. 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 may be used standalone or mixed with autograft. When used in intervertebral body fusion procedures, MagnetOs Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Putty resorbs and is replaced with bone during the healing process.
Device Description:
MagnetOs Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects. MagnetOs Putty consists of 65-75% Tri-Calcium Phosphate (TCP - Cas(PO4)2) and 25-35% Hydroxyapatite (HA - Ca10(PO4)6 (OH)2) granules with a porous trabecular
5
Image /page/5/Picture/0 description: The image shows the logo for Kuros Biosciences. The logo consists of a stylized, abstract shape on the left and the company name "Kuros Biosciences" on the right. The abstract shape is composed of three teardrop-like elements in green, blue, and yellow, arranged in a circular fashion. The company name is written in a simple, sans-serif font.
structure that resembles the interconnected porosity of human cancellous bone. The surface of the granules in MagnetOs Putty is covered with needle-shaped features that are submicron in size. The granules are premixed with a synthetic polymeric binder. The biocompatible polymeric binder is composed of Poly L (Lactic Acid) (PLA) and Poly(Ethylene Glycol) (PEG) in a triblock polymer PLA-PEG-PLA; which consists of 10-20% PLA and 80-90% PEG.
The fast-resorbing polymeric binder in the subject device is designed to improve handling properties, as well as reduce the risk of granules migration. While the polymeric binder is rapidly resorbed after implantation, the granules guide the three-dimensional regeneration of bone in the defect site into which it is implanted.
When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant resorbs and is replaced by bone during the natural process of bone remodeling.
MagnetOs Putty is a ready-for-use product. Pressure applied by manipulation allows the shaping of the devices to conform to the contours of bony defects. MagnetOs Putty is gammasterilized, comes in several sizes in block form and is sterile packaged for single use only.
MagnetOs Putty is MRI (Magnetic Resonance Imaging) Safe.
Predicate Device:
Kuros Biosciences submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, MagnetOs Putty is substantially equivalent in indications, design principles, and performance to the following predicate devices:
Primary Predicate: NuVasive Attrax Putty, NuVasive, Inc., K203714 Additional Predicate: MagnetOs Putty, Kuros Biosciences B.V, K230736
Performance Testing Summary:
The purpose of this submission is to expand the indications for use of the MagnetOs Putty 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 (K230736), non-clinical testing data, supplemented with clinical 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 analytical characterization, chemical composition, physical properties, and animal functional studies.
The subject device is categorized as direct-patient contact with bone/tissue for permanent duration (>30 days). Biocompatibility was performed in accordance with "ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
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Image /page/6/Picture/0 description: The image contains the logo for Kuros Biosciences. The logo consists of a stylized, abstract symbol on the left and the company name "Kuros Biosciences" on the right. The symbol is composed of three teardrop shapes in green, blue, and yellow, arranged in a circular fashion. The company name is written in a dark gray sans-serif font.
MagnetOs Putty met the acceptance criteria for the Limulus amebocyte lysate (LAL) test, gel clot method (Bacterial endotoxins test (BET)) per Ph.Eur. 2.6.14, Bacterial Endotoxins and USP , Bacterial Endotoxins. MagnetOs Putty passed the Materials-Mediated Pyrogenicity Rabbit study per USP 39-NF34 and is marketed as "Non-Pvrogenic". A sterilization validation was performed and complies with ISO 11137, "Sterilization of Sterilization of Health Care Products - Radiation", to ensure a sterility assurance level (SAL) of 10-6. Product and sterile-barrier shelf-life studies were conducted per ISO 11607, "Packaging for terminally sterilized medical devices".
In-vitro studies showed that MagnetOs Putty 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 as putties 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 Putty, K230736). The performance of the reference device has previously been assessed at the time of the 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 Putty is as safe, as effective, and performs as well as the predicate devices.