(30 days)
No
The summary describes a bone void filler with a chemical composition and physical properties, with no mention of AI/ML for analysis, prediction, or decision support.
Yes
The device is intended to fill bone voids and defects, which is a therapeutic intervention aimed at restoring function and structure to the bone.
No
The device is described as a bone void filler that resorbs and is replaced with bone. Its purpose is therapeutic (filling bony voids), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly states it is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that GRAFTYS® QUICKSET is an injectable bone substitute intended to be placed or injected directly into bony voids or defects within the skeletal system. It is a material used in vivo (within the living body) to fill bone gaps and promote bone regeneration.
The device's function is to physically fill a void and then be resorbed and replaced by bone, which is a therapeutic action performed directly on the patient's body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Product codes
MQV
Device Description
GRAFTYS® QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment missing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. In vivo, this apatite, which hardens, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS® QUICKSET is a sterile, nonpyrogenic, single-use product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities 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
The proposed device and predicate device have identical composition, physical structure, packaging, packaging, sterilization and manufacturing process. As such, no additional bench testing was conducted. All previous verification and validation testing performed for the predicate device according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device: Guidance for Industry and FDA June 2, 2003, cleared under K093343, is still applicable to the modified device excepting for setting time, compressive strength and product shelf life and support the performance of the subject device
Key Metrics
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 12, 2023
Graftys Cedric Bonneau Regulatory Affairs Director 415 Rue Claude Nicolas Ledoux Eiffel Park Bat. D Aix en Provence, 13854 France
Re: K231714
Trade/Device Name: GRAFTYS® OUICKSET Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: June 12, 2023 Received: June 12, 2023
Dear Cedric Bonneau:
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.
1
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 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.
Jesse Muir -S
Jesse Muir, 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) K231714
Device Name GRAFTYS® QUICKSET
Indications for Use (Describe)
GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
GRAFTYS® QUICKSET
Submitter Information
GRAFTYS Eiffel Park Bât. D 415 Rue Claude Nicolas Ledoux 1954 Aix-en-Provence Cedex 3 Phone: + 33 (0) 4 42 60 30 00
Facsimile: + 33 (0) 4 42 60 30 11
Contact Person: Cédric Bonneau
Date Prepared: July 12, 2023
Proprietary Name: GRAFTYS® QUICKSET
Common or Usual Name: Filler, bone void, calcium compound
Classification Name : Resorbable calcium salt bone void filler device
Predicate Device:
Primary Predicate Device: K093343, GRAFTYS® QUICKSET; GRAFTYS Reference Device: K082498, GRAFTYS® HBS; GRAFTYS Reference Device: K070437, PRO-DENSE™; WRIGHT MEDICAL TECHNOLOGY, INC.
Purpose of the Special 510(k) notice: The GRAFTYS® QUICKSET is a modification of specifications to the cleared GRAFTYS® QUICKSET.
Intended Use/Indications for Use
GRAFTYS® QUICKSET is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS® QUICKSET is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Device Description
GRAFTYS® QUICKSET is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment missing syringe which is pre-filled with a powder (calcium phosphate salts and HPMC) and with a phosphate-based (Na2HPO4) aqueous solution. When these two components are mixed in the syringe, an injectable calcium-deficient apatite is athermally formed. In vivo, this apatite, which hardens, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS® QUICKSET is a sterile, nonpyrogenic, single-use product.
4
Technological Characteristics
The subject device is identical to that of the predicate in terms of chemical composition, intended use/indications for use and operating principles. The subject device has an updated setting time and shelf life.
Performance Data
The proposed device and predicate device have identical composition, physical structure, packaging, packaging, sterilization and manufacturing process. As such, no additional bench testing was conducted. All previous verification and validation testing performed for the predicate device according to the Guidance Class II Special Controls Guidance Document: Resorbable calcium salt bone void filler device: Guidance for Industry and FDA June 2, 2003, cleared under K093343, is still applicable to the modified device excepting for setting time, compressive strength and product shelf life and support the performance of the subject device
Substantial Equivalence
The modified GRAFTYS® QUICKSET has the same intended use/indications for use, principles of operation and technological characteristics as the cleared GRAFTYS® QUICKSET. The minor differences in the modified GRAFTYS® QUICKSET release specifications do not raise any new questions of safety or effectiveness. Thus, the modified GRAFTYS® QUICKSET is substantially equivalent to its predicate devices.
Conclusions
The modified GRAFTYS® QUICKSET is claimed to be substantially equivalent in terms of safety and effectiveness to the predicate GRAFTYS® QUICKSET as a resorbable calcium salt bone void filler device. The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. The indications for use of the subject device were not changed as a result of the modified specifications and the fundamental scientific technology of the device, including the bone void filler's mechanism of action, performance remains identical to the original product.