(180 days)
Not Found
No
The description focuses on the material properties and physical function of the bone substitute, with no mention of AI or ML capabilities.
Yes
The device is intended to treat bony voids or defects by providing a bone void filler that resorbs and is replaced by bone during the healing process, which aligns with the definition of a therapeutic device.
No
The device is a bone void filler intended to treat bony defects by providing a scaffold for bone regeneration, not to diagnose a condition.
No
The device description clearly states it is an injectable bone substitute made of calcium phosphate salts and an aqueous solution, which are physical components, not software.
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 GRAFTYS®HBS is a bone void filler intended to be placed or injected into bony voids or defects in the skeletal system. This is a therapeutic and structural function within the body.
- Device Description: The description details a synthetic calcium phosphate bone substitute that is injected and hardens in vivo, eventually being resorbed and replaced by bone. This is a material implanted or used within the body for a specific medical purpose.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. GRAFTYS®HBS is used within the body to fill bone voids.
N/A
Intended Use / Indications for Use
GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and the 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 (comma separated list FDA assigned to the subject device)
MQV
Device Description
GRAFTYS®HBS is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing 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, 8cc of an injectable calcium-deficient apatite is athermally formed. In-vivo, this apatite which hardens in approximately 15 min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®HBS is a sterile, non-pyrogenic, single-use product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (the extremities and the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro and in-vivo testing, performed 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, support the substantial equivalence between GRAFTYS®HBS and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows a handwritten letter "G" in a bold, black font. The letter appears to be written with a thick marker or pen, giving it a strong, defined look. To the right of the letter "G", there is a smaller, less distinct character or symbol that is difficult to discern due to its size and clarity.
Koryys
Grafalys
FEB 2 5 2009
GRAFTYS®HBS Resorbable Bone Void Filler 510(k) Summary
Prepared: August 22nd, 2008
1. Submitter Information
| Name : | GRAFTYS |
|---|---|
| Address : | Eiffel Park – Bât D |
| 415, rue Claude Nicolas Ledoux- | |
| 13 854 AIX EN PROVENCE Cedex3 | |
| FRANCE | |
| Telephone: | + 33 (0) 4 42 60 30 00 |
| Facsimile: | + 33 (0) 4 42 60 30 11 |
| Contact: | Anthony LE NAOUR - Regulatory Manager |
Name of Device 2.
| Trade Name: | GRAFTYS®HBS |
|---|---|
| Common Name: | Resorbable calcium salt bone void filler device |
| Classification name: | Resorbable calcium salt bone void filler device (CFR 888.3045 |
| ; Product Code : MQV) |
3. Legally Marketed Predicate Device
Predicate NORIAN® SRS® - Resorbable calcium salt bone void filler device [K011897]
4. Device Description
GRAFTYS®HBS is an injectable self-hardening macroporous synthetic calcium phosphate bone substitute. It comes in a double-compartment mixing 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, 8cc of an injectable calcium-deficient apatite is athermally formed. In-vivo, this apatite which hardens in approximately 15 min, is then resorbed and replaced by bone. The injection is administered manually or using a delivery gun. GRAFTYS®HBS is a sterile, non-pyrogenic, single-use product.
1
Image /page/1/Picture/0 description: The image shows a logo with a stylized letter "G" in a bold, slightly rough font. To the upper right of the "G", there's a smaller superscript "5". Below the logo, the word "Craftys" is written in a font that appears textured or slightly distressed, giving it a handmade or vintage feel. The overall impression is that of a brand or company name with a distinctive, slightly rustic aesthetic.
5. Intended Use
GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (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.
6. Technological characteristics
GRAFTYS®HBS and the predicate device NORIAN® SRS® have the same intended use, the same principle of operation and very similar technological characteristics. The minor technological differences do not raise any new issues of safety or effectiveness.
7. Non clinical performance data
In vitro and in-vivo testing, performed 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, support the substantial equivalence between GRAFTYS®HBS and the predicate device.
8. Conclusion
GRAFTYS®HBS is claimed to be substantially equivalent in term of safety and effectiveness to the predicate devices as a resorbable calcium salt bone void filler device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings.
Graftys % Mr. Anthony Le Naour Regulatory Manager 415, rue Claude Nicolas Ledoux F-13854 Aix en Provence Cedx3
FEB 2 5 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K082498
France
Trade/Device Name: GRAFTYS® HBS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable bone substitute Regulatory Class: II Product Code: MQV Dated: January 30, 2009 Received: February 5, 2009
Dear Mr. Le Naour:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Anthony Le Naour
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Confidential
510(k) Premarket Notification Graftys GRAFTYS®HBS- Resorbable Bone Void Filler
Statement of Indications for Use
510(k) Number (if known):
Device Name:
GRAFTYS®HBS
Indications For use:
GRAFTYS®HBS is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. GRAFTYS®HBS is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and the 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE IF NEEDED)
A BE HERE BE BREAK (ODE) Concurrence of CDRH, OA Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number L024151