(18 days)
No
The description focuses on the material composition and physical form of a bone void filler, with no mention of AI or ML capabilities.
Yes.
The device is a bone void filler intended for use in bony voids or gaps, which is a therapeutic purpose to aid in the healing process of bone defects.
No
Explanation: ReBOSSIS is a bone void filler intended for use in bony voids or gaps. Its function is to be resorbed and replaced by host bone, aiding in the healing process. It does not provide any diagnostic information or analysis.
No
The device description clearly states that ReBOSSIS is a composite material consisting of physical components (beta-tricalcium phosphate, siloxane-containing vaterite, and poly(L-lactide-co-glycolide)) in a physical form (glass wool-like). This indicates it is a physical medical device, not software-only.
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 ReBOSSIS is a bone void filler intended for use in bony voids or gaps within the skeletal system. It is a material that is physically placed into the body to aid in bone healing.
- Device Description: The description details the composition and physical form of the material itself, designed to be implanted.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples (blood, urine, tissue, etc.).
- Anatomical Site: The anatomical sites listed are parts of the skeletal system where the material is implanted, not where biological samples are collected for analysis.
ReBOSSIS is a medical device used for surgical implantation and bone regeneration, not a diagnostic tool.
N/A
Intended Use / Indications for Use
ReBOSSIS is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space). In the extremities and pelvis ReBOSSIS may be used without hydrated with blood. In the posterolateral spine and intervertebral disc space, ReBOSSIS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. When used in intervertebral body fusion procedures, ReBOSSIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
Product codes
MQV
Device Description
ReBOSSIS is composite material consisting of beta-tricalcium phosphate (B-TCP), siloxanecontaining vaterite (a form of calcium carbonate, CaCO3), and a resorbable scaffold of poly(Llactide-co-glycolide), or PLGa. The electrospinning process used in manufacturing ReBOSSIS results in a glass wool-like (or cotton ball-like) physical form. Due to its physical form, ReBOSSIS is flexible and can easily adapt to and fill in defects in appropriate amounts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space)
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)
The purpose of this submission is to expand the indications for use of the ReBOSSIS device to include its use in the intervertebral disc space in conjunction with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
As the subject device is identical to the previously cleared reference device (K172573), it was determined that the non-clinical testing data and the animal testing data provided in the prior submission is adequate to support the expanded indications proposed in the current submission. A clinical rationale was provided to justify that the use of the subject device in the posterolateral spine is a worst-case use scenario and to support the performance and safety of the expanded indications for use to include use of ReBOSSIS with intervertebral body fusion devices cleared by FDA for use with bone void fillers.
In support of the prior clearance (K172573), 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.
The performance testing and supporting clinical rationale are further detailed in the "Performance Testing" Section of the subject submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Catalyst Bone Void Filler, OssDsign AB (K232315), REBOSSIS85, ORTHOREBIRTH Co., Ltd. (K172573)
Reference Device(s)
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
March 4, 2024
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OrthoRebirth Co., Ltd. % Justin Eggleton Vice President, Head of Musculoskeletal Regulatory Affairs Mcra, LLC 803 7th Street NW Washington, District of Columbia 20001
Re: K240453
Trade/Device Name: ReBOSSIS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: January 17, 2024 Received: February 15, 2024
Dear Justin Eggleton:
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,
Sara S. Thompson -S
For
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
K240453 - Justin Eggleton
Enclosure
3
Indications for Use
510(k) Number (if known) K240453
Device Name ReBOSSIS
Indications for Use (Describe)
ReBOSSIS is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space). In the extremities and pelvis ReBOSSIS may be used without hydrated with blood. In the posterolateral spine and intervertebral disc space, ReBOSSIS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. When used in intervertebral body fusion procedures, ReBOSSIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
| Device Trade Name: | REBOSSIS |
|---|---|
| Manufacturer: | ORTHOREBIRTH Co., Ltd. |
| 3-17-43 Chigasaki Higashi | |
| Tsuzuki-ku Yokohama, Kanagawa, 224-0033, Japan | |
| Contact: | Justin Eggleton |
| Vice President, Head of Musculoskeletal Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street NW | |
| Washington, DC 20001 | |
| Office: 202-552-5804 | |
| Email: jeggleton@mcra.com | |
| Prepared by: | MCRA, LLC |
| 803 7th Street, NW, 3rd Floor | |
| Washington, DC 20001 | |
| Office: 202.552.5800 | |
| Date Prepared: | March 4, 2024 |
| Classifications: | 21 CFR §888.3045 |
| Class: | II |
| Product Codes: | MQV |
| Primary Predicate: | Catalyst Bone Void Filler, OssDsign AB (K232315) |
| Additional Predicate: | REBOSSIS85, ORTHOREBIRTH Co., Ltd. (K172573) |
Indications For Use:
ReBOSSIS is intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. ReBOSSIS is indicated to be packed gently into bony voids or gaps of the skeletal system (extremities, pelvis, posterolateral spine, and intervertebral disc space). In the extremities and pelvis ReBOSSIS may be used without hydration or hydrated with blood. In the posterolateral spine and intervertebral disc space, ReBOSSIS is to be used hydrated with bone marrow aspirate and mixed with autograft bone. When used in intervertebral body fusion procedures, ReBOSSIS must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.
5
Device Description:
ReBOSSIS is composite material consisting of beta-tricalcium phosphate (B-TCP), siloxanecontaining vaterite (a form of calcium carbonate, CaCO3), and a resorbable scaffold of poly(Llactide-co-glycolide), or PLGa. The electrospinning process used in manufacturing ReBOSSIS results in a glass wool-like (or cotton ball-like) physical form. Due to its physical form, ReBOSSIS is flexible and can easily adapt to and fill in defects in appropriate amounts.
Predicate Device:
ORTHOREBIRTH Co., Ltd. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, ReBOSSIS 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: Catalyst Bone Void Filler, OssDsign AB (K232315) Additional Predicate: ReBOSSIS85, ORTHOREBIRTH Co., Ltd. (K172573)
Performance Testing Summary:
The purpose of this submission is to expand the indications for use of the ReBOSSIS device to include its use in the intervertebral disc space in conjunction with an intervertebral body fusion device cleared by FDA for use with a bone void filler.
As the subject device is identical to the previously cleared reference device (K172573), it was determined that the non-clinical testing data and the animal testing data provided in the prior submission is adequate to support the expanded indications proposed in the current submission. A clinical rationale was provided to justify that the use of the subject device in the posterolateral spine is a worst-case use scenario and to support the performance and safety of the expanded indications for use to include use of ReBOSSIS with intervertebral body fusion devices cleared by FDA for use with bone void fillers.
In support of the prior clearance (K172573), 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.
The performance testing and supporting clinical rationale are further detailed in the "Performance Testing" Section of the subject submission.
6
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the OssDsign Catalyst Bone Void Filler (K232315) 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 volumes. 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 additional predicate (ReBOSSIS85, K172573). 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. ReBOSSIS is as safe, as effective, and performs as well as the predicate devices.