(161 days)
No
The summary describes a synthetic bone graft substitute material and its intended use. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies mentioned are bench tests related to material properties.
Yes
This device is a bone graft substitute that promotes bone regeneration and is eventually replaced by new bone, directly contributing to the healing process of bony voids or defects.
No
Explanation: The device, Genex® Bone Graft Substitute, is described as a synthetic resorbable material used to promote bone regeneration in osseous defects. Its intended use is for filling bony voids or defects, not for diagnosing conditions.
No
The device description clearly states it is a "synthetic resorbable material" supplied as a "powder and mixing solution" that forms a "mouldable cohesive paste" and "hard but resorbable matrix" when set. This describes a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material that is implanted into the body to fill bone voids and promote bone regeneration. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a synthetic, resorbable material that is mixed and sets to form a matrix within the body. This aligns with a medical device used for treatment or repair, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Genex® Bone Graft Substitute does not fit this description.
N/A
Intended Use / Indications for Use
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
• Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure
• Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (ic long bones, extremities, posterolateral spine and pelvis)
• Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
• The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that resorbs and is replaced with bone during the healing process
Product codes
MQV
Device Description
Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste. When injected the mixture sets to form Genex® Bone Graft substitute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Genex® Bone Graft Substitute, accessories and packaging are not made from natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (ic long bones, extremities, posterolateral spine and pelvis)
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 including Biocompatibility testing, Shelf-Life validation studies and Porosity testing have been provided with this submission.
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.
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February 04, 2022
Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biocomposites Ltd Simon Fitzer Compliance Director Keele Science Park Keele, Stafforshire ST5 5NL United Kingdom
Re: K212721
Trade/Device Name: Genex® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 13, 2022 Received: January 18, 2022
Dear Mr. Fitzer:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212721
Device Name Genex® Bone Graft Substitute
Indications for Use (Describe) INTENDED USE
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
• Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure
· Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (ic long bones, extremities, posterolateral spine and pelvis)
· Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are to be gently packed into the defect
· The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that 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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510(k) Summary
Genex® Bone Graft Substitute
Date summary was prepared 24th January 2022
| Applicant: | Biocomposites Ltd
Keele Science Park
Keele
Staffordshire
England
ST5 5NL |
|-------------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Miss Kelsey Gomes
Tel: +44 (0) 1782 338580
Email: kjg@biocomposites.com |
| Classification Name: | Filler, bone void, calcium compound |
| Common/Usual Name: | Bone void filler |
| Trade/Proprietary Name: | Genex® Bone Graft Substitute |
| Product code: | MVQ (21CFR 888.3045) |
Device Description:
Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste. When injected the mixture sets to form Genex® Bone Graft substitute, a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.
Genex® Bone Graft Substitute, accessories and packaging are not made from natural rubber latex.
Intended Use / Indications for Use:
Genex® Bone Graft Substitute injectable paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process
• Genex® Bone Graft Substitute is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure
• Genex® Bone Graft Substitute is indicated to be gently packed into voids or defects of the skeletal system (i.e long bones, extremities, posterolateral spine and pelvis)
• Genex® Bone Graft Substitute resultant paste can be injected, digitally packed into the bone in situ or moulded into solid implants that are to be gently packed into the defect
4
• The bony defects or cavities may be surgically created or the result of traumatic injury. Genex® Bone Graft Substitute provides a bone graft substitute that resorbs and is replaced with bone during the healing process
Summary of Technology:
Genex® Bone Graft Substitute is substantially equivalent to the primary predicate device Genex® (K082381). Technological differences are that the subject device Genex® Bone Graft Substitute is presented as a closed mixing system compared to the predicate device Genex® (K082381). Additional differences between the subject device Genex® Bone Graft Substitute and predicate device (K082381) include the number of syringes supplied and method of mixing.
The technological differences do not raise any concerns regarding safety and effectiveness of the device.
Non Clinical Testing:
Data supplied demonstrates that Genex® Bone Graft Substantially equivalent to the primary predicate device Genex® (K082381) and any differences do not raise any concerns regarding the safety and effectiveness of the device. Bench testing including Biocompatibility testing, Shelf-Life validation studies and Porosity testing have been provided with this submission.
Substantial Equivalence:
The indications, contraindications, risks and potential adverse events are the same as identified in the predicate device and are thus substantially equivalent.
Documentation provided demonstrates that the Genex® Bone Graft Substitute is substantially equivalent to the legally marketed predicate device in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of the subject device.