(60 days)
Not Found
No
The description focuses on the material properties and intended use of a bone graft substitute, with no mention of AI or ML technology.
No.
The device is a bone graft substitute and void filler, which is used to fill bony defects and resorb over time, being replaced by bone during healing. It restores a body structure, but does not provide a therapeutic effect in the way that a device used to treat a disease or condition would.
No
Explanation: The device, Genex®, is described as a bone graft substitute and bone void filler, used to replace bone during healing. Its function is therapeutic (filling voids and aiding bone regeneration), not diagnostic (identifying or characterizing disease/conditions).
No
The device description clearly states that Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, premeasured mixing solution, and tools necessary to mix the components into a paste. These 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 Genex® is a bone graft substitute for filling bony voids or defects. This is a therapeutic and structural application within the body.
- Device Description: The description details a synthetic bioabsorbable calcium salt product that is mixed into a paste or molded into implants for placement within bone. This is a material intended for direct interaction with the patient's tissues.
- 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. Genex® is used inside the body to fill bone defects.
N/A
Intended Use / Indications for Use
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. 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® provides a bone graft substitute 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
Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, premeasured mixing solution and tools necessary to mix the components into a paste. These products are provided sterile for singe patient use. When mixed according to directions, the Gonex® Bone Graft Substitute produces biodegradable, radiopaque paste/moulded blocks that resorb in approximately 6 -- 9 months when used according to labelling.
After the granular powder is hydrated using all of the mixing solution supplied in each pack, the resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are gently paced into non-load bearing voids or gaps of the skeletal system (i.c. the extremitics, spinc and pelvis). These bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the hone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
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, spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Test results confirm that Genex® Bone Graft Substitute provides a bone void filler which, when placed in contact with healthy bone, resobs and is replaced with bone during the healing process.
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.
K021551, K994337, K031040, K022622
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
MAY - 7 2004
Exhibit V
510(K) Summary of Safety and Effectiveness
| (1) | Submitter's name: | Biocomposites Ltd |
|---|---|---|
| Submitter's address: | Etruscan Street, Etruria, Stoke-on- | |
| Trent, ST1 5PQ, England | ||
| Submitter's telephone number: | 44 (0) 1782 206500 | |
| Contact person: | Stephen Bratt | |
| Date summary prepared: | 12th February 2004 | |
| (2) | Trade or proprietary device name: | Genex® Bone Graft Substitute |
| Common or usual name: | Bone Void Filler, Bone Graft Substitute | |
| Classification name: | Resorbable Calcium Salt Bone Void Filler | |
| Device, Calcium Sulphate Preformed Pellet |
| (3) | Legally marketed predicate device: | ||
|---|---|---|---|
| Stimulan® Bone Void Filler Kit | Biocomposites Ltd | K021551 | |
| Vitoss™ Scaffold | Orthovita Inc | K994337 | |
| Therifil™ Bone Void Filler | Therics Inc | K031040 | |
| Cem-Ostetic Bone Void Filler | Berkeley Advanced Biomaterials Inc | K022622 |
(4) Subject device description:
Genex® Bone Graft Substitute consists of synthetic bioabsorbable calcium salts, premeasured mixing solution and tools necessary to mix the components into a paste. These products are provided sterile for singe patient use. When mixed according to directions, the Gonex® Bone Graft Substitute produces biodegradable, radiopaque paste/moulded blocks that resorb in approximately 6 -- 9 months when used according to labelling.
After the granular powder is hydrated using all of the mixing solution supplied in each pack, the resultant paste can be injected, digitally packed into the bone void to cure in situ or moulded into solid implants that are gently paced into non-load bearing voids or gaps of the skeletal system (i.c. the extremitics, spinc and pelvis). These bone voids may be surgically created osseous defects or osscous defects created from traumatic injury to the hone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
(5) Subject device intended use:
Genex® is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure. 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® provides a bone graft substitute that resorbs and is replaced with hone during the healing process.
(6) Technological characteristics:
Genex® has the same technological characteristics as the predicate devices.
1
Performance data: (7)
Test results confirm that Genex® Bone Graft Substitute provides a bone void filler which, when placed in contact with healthy bone, resorbs and is replaced with bone during the healing process.
Basis for substantial equivalence: (8)
Genex® is equivalent in design, materials, intended use, performance indications and contraindications to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 7 2004
Biocomposites Ltd. J. Stephen Bratt Managing Director Etruscan Street, Etruria, Stoke-on-Trent, Staffordshire. ST1 5PQ, England
Re: K040600
Trade/Device Name: Genex® Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: March 2, 2004 Received: M arch 8, 2004
Dear Mr. Bratt:
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, listing 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
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melkers
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K040600
Device Name:
Genex Bone Graft Substitute
Indications For Use:
Indications For Use:
Genexe is indicated only for bony voids or defects/gaps that are not intrinsic to the stability of the bony structure.
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 provides a bone graft substitute that resorbs and is replaced with bone during the healing process.
Genex® is provided sterile for single use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Wilkerson
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040600
Page 1 of _ 1