(36 days)
MagnetOs Easypack Putty is intended to filly 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 Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.
MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects, MagnetOs Easypack Putty consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
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 Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects. MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single use only.
The provided document is a 510(k) Summary for a medical device (MagnetOs Easypack Putty) and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the context of software/AI performance.
This summary primarily focuses on demonstrating substantial equivalence to a predicate device for an expanded indication for use. It mentions general performance testing and supporting rationale, but it does not detail specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or the methodology of an AI/software performance study with a test set, ground truth, or expert involvement as requested in your prompt.
Therefore, I cannot provide the requested information based on the given text. The document describes a physical medical device (bone void filler) and its regulatory clearance process, not a software or AI-driven diagnostic or therapeutic device.
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December 15, 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the full name. The full name of the agency is "U.S. Food & Drug Administration".
Kuros Biosciences B.V. Hen Baron Regulatory Affairs Manager Prof. Bronkhorstlaan 10, building 48 Bilthoven, 3723MB Netherlands
Re: K233607
Trade/Device Name: MagnetOs Easypack 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 8, 2023 Received: November 9, 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"
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(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).
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 Jesse Muir -> Muir -> Muir ->
Date: 2023.12.15 11:35:48 -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
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Enclosure
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Indications for Use
Submission Number (if known)
Device Name
MagnetOs Easypack Putty
Indications for Use (Describe)
MagnetOs Easypack Putty is intended to filly 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 Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Easypack 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)
ver-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Kuros Biosciences. The logo consists of a stylized, abstract symbol on the left and the company name on the right. The symbol is composed of three teardrop shapes in green, blue, and yellow, arranged in a circular pattern. The text "Kuros Biosciences" is written in a simple, sans-serif font.
510(k) Summary
| Trade Name: | MagnetOs Easypack Putty |
|---|---|
| Manufacturer: | Kuros Biosciences B.V.Prof. Bronkhorstlaan 10, building 48.3723 MB Bilthoven, The Netherlands+31 (0)30 229 7280 |
| Contact: | Hen Baron, MScRegulatory Affairs ManagerProf. Bronkhorstlaan 10, building 48, 3723 MB Bilthoven,The NetherlandsOffice: +31 (0)30 229 7280hen.baron@kurosbio.com |
| Prepared by: | MCRA, LLC803 7th Street, NW, 3rd FloorWashington, DC 20001Office: 202.552.5800 |
| Date Prepared: | December 11, 2023 |
| Classifications: | 21 CFR 888.3045 |
| Class: | II |
| Product Codes: | MQV |
| Primary Predicate: | NuVasive Attrax Putty (K203714) |
| Additional Predicate: | MagnetOs Easypack Putty (K211201) |
Indications For Use:
MagnetOs Easypack Putty is intended to filly 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 Easypack Putty must be used with autograft as a bone extender. When used in intervertebral body fusion procedures, MagnetOs Easypack Putty must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
MagnetOs Easypack Putty resorbs and is replaced with bone during the healing process.
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Image /page/5/Picture/0 description: The image shows 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 pattern. The text is in a simple, sans-serif font.
Device Description:
MagnetOs Easypack Putty is a synthetic, resorbable, osteoconductive bone void filler for the repair of bony defects, MagnetOs Easypack Putty consists of 65-75% tri-calcium phosphate (TCP - Ca3(PO4)2) and 25-35% hydroxyapatite (HA - Ca10(PO4)6(OH)2) granules, premixed with a synthetic polymeric binder that provides cohesion between the granules.
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 Easypack Putty is a ready-to-use product. Pressure applied by manipulation allows users to shape MagnetOs Easypack Putty to conform to the contours of bony defects. MagnetOs Easypack Putty is provided in open-ended syringes in a range of product volumes. MagnetOs Easypack Putty is gamma-sterilized and sterile packaged for single 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 Easypack Putty 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 Easypack Putty (K211201)
Performance Testing Summary:
The purpose of this submission is to expand the indications for use of the MagnetOs Easypack 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 (K211201), 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.
In-vitro studies showed that MagnetOs Easypack 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.
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Image /page/6/Picture/0 description: The image shows 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-shaped elements in green, blue, and yellow, arranged in a circular fashion. The company name is written in a simple, sans-serif font.
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 Easypack Putty, K211201). 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 Easypack Putty is as safe, as effective, and performs as well as, or better, than the predicate devices.
§ 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.