(57 days)
Not Found
Not Found
No
The summary describes a bone graft substitute material and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as a "Bone Graft Substitute" intended to fill voids or gaps in the skeletal system and treat surgically created osseous defects, indicating it is used for therapeutic purposes to aid in bone healing.
No
Explanation: The device is a bone graft substitute intended to fill voids or gaps in the skeletal system, which is a therapeutic function, not a diagnostic one.
No
The device is described as a "Bone Graft Substitute," which is a physical material intended for implantation or placement within the body. This clearly indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "bone void filler" for surgical procedures to fill gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or screen for health issues.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from a diagnostic purpose.
- No Mention of Diagnostic Modalities: There is no mention of image processing, AI, DNN, ML, or input imaging modalities, which are often associated with diagnostic devices that analyze data.
In summary, the device's function is to physically fill bone voids during surgery, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
OsteoCNX Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). OsteoCNX Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. OsteoCNX Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), OsteoCNX Bone Graft Substitutes are resorbed with bone during the healing process
Product codes
MQV
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities, pelvis, posterior lateral 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
January 25, 2023
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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Converg Engineering Gustavo R. Prado, Ph.D. President 2305 Historic Decatur Road San Diego, California 92106
Re: K223563
Trade/Device Name: OsteoCNX Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: October 13, 2022 Received: November 29, 2022
Dear Dr. Prado:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 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.
Sara S. Thompson -S 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223563
Device Name OsteoCNX
Indications for Use (Describe)
OsteoCNX Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system not intrinsic to the stability of the bony structure (extremities, pelvis, posterior lateral spine). OsteoCNX Bone Graft Substitute is also indicated for use in the treatment of surgically created osseous defects created from traumatic injury to the bone. OsteoCNX Bone Graft Substitute must be wetted with bone marrow aspirate or, when used in the posterolateral spine, autologous bone must also be added (50/50 ratio by volume). Following placement in the bony void or gap (defect), OsteoCNX Bone Graft Substitutes are resorbed 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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