(144 days)
Not Found
No
The summary describes a bone graft substitute made of calcium phosphate ceramic. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a bone void filler intended to be replaced by bone during the healing process, not to provide therapy itself.
No
TRIBONE 80™ is a bone void filler and bone graft substitute, intended to fill gaps in the skeletal system and be replaced by bone during healing, rather than to diagnose medical conditions.
No
The device description clearly states that TRIBONE 80™ is a physical bone graft substitute made of calcium phosphate ceramic, available in granules, sticks, and blocks. This indicates it is a hardware device, not software.
Based on the provided information, TRIBONE 80™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that TRIBONE 80™ is a bone void filler for surgical or traumatic defects in the skeletal system. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a ceramic bone graft substitute used to fill physical voids in bone. This is a material implanted into the body, not a reagent or instrument used to test samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, 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. TRIBONE 80™ does not fit this definition.
N/A
Intended Use / Indications for Use
TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.
TRIBONE 80™ is to be used in association with adequate post-operative immobilization.
TRIBONE 80™ is provided sterile for single patient use.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
TRIBONE 80™ is a bone graft substitute. TRIBONE 80™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 20% Hydroxyapatite (HA) and 80% beta-Tricalcium Phosphate (ß-TCP). TRIBONE 80™ is available in granules, sticks and blocks. TRIBONE 80™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). TRIBONE 80™ can also be mixed with autograft. TRIBONE 80™ is provided sterile for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (e.g. extremities, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
K07/121
Image /page/0/Picture/1 description: The image shows the logo for "Biomatlante". The logo consists of a hexagon shape in the upper left corner, and the text "Biomatlante" is written below the shape. The hexagon is shaded with darker colors at the top and lighter colors at the bottom. The text is written in a simple, sans-serif font.
TRIBONE 80 ™
SEP 1 1 2007
510(k) Summary
BIOMATLANTE ZA DES IV NATIONS 5, rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE Phone: 0033 228 020 009 Fax: 0033 228 020 010
Contact: Laurence Letertre Regulatory Affairs Manager
This summary was prepared on April 200, 2007
1. DEVICE IDENTIFICATION
| Trade Name: | TRIBONE 80™ | |
|---|---|---|
| Common Name: | Resorbable bone substitute | |
| Classification Name : | Resorbable calcium salt bone void filler | |
| device | ||
| Product Code : | MQV | |
| Regulatory Status : | Class II | |
| CFR Section : | 888.3045 |
2. PREDICATE DEVICES
| Product Code | Applicant | 510(k) # | Product |
|---|---|---|---|
| MQV | Orthotec | K040514 | EOVIA |
| MQV | Howmedica | K033258 | Bone Save |
3. DEVICE DESCRIPTION
TRIBONE 80™ is a bone graft substitute. TRIBONE 80™ is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 20% Hydroxyapatite (HA) and 80% beta-Tricalcium Phosphate (ß-TCP). TRIBONE 80™ is available in granules, sticks and blocks. TRIBONE 80™ may be used with physiological saline, patient's own serum, whole blood, or bone marrow aspirate (BMA). TRIBONE 80™ can also be mixed with autograft. TRIBONE 80™ is provided sterile for single patient use.
Rev. 9/10/2007
Section 04 Page 1 of 2
1
Image /page/1/Picture/0 description: The image shows the logo for "Biomatlante". The logo consists of a hexagon shape that is black on the left side and fades to white on the right side. Below the hexagon is the word "Biomatlante" in a simple, sans-serif font.
TRIBONE 80 ™
510(k) Summary
4. INTENDED USE
TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.
TRIBONE 80™ is to be used in association with adequate post-operative immobilization.
5. SUBSTANTIAL EQUIVALENCE INFORMATION
The principal component and intended use of TRIBONE 80™ is the same as previously cleared devices. TRIBONE 80™ and the predicate device are substantially equivalent in design, materials of construction and function.
The safety and effectiveness of TRIBONE 80™ presented in this submission is adequately supported by the substantial equivalence information, safety and performance data provided within this Premarket Notification.
Rev. 9/10/2007
Section 04 Page 2 of 2
2
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 1 2007
BIOMATLANTE % Ms. Adeline Filliâtre Regulatory Affairs Manager ZA DES IV NATIONS 5, rue Edouard Belin -F-44360 VIGNEUX DE BRETAGNE FRANCE
Re: K071121 Trade/Device Name: TRIBONE 80TM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 19, 2007 Received: August 2, 2007
Dear Mr. Filliâtre:
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
3
Page 2 - Ms. Adeline Filliâtre
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. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchholz
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for "Biomatlante". The logo consists of a black hexagon shape in the upper left corner, and the word "Biomatlante" is written in a simple, sans-serif font below and to the right of the hexagon. The text is in a lighter color, possibly gray or a light shade of blue. The overall design is clean and modern.
TRIBONE 80™
Indications for Use
510(k) Number (if known): K 071121
Device Name: TRIBONE 80 ™
Indications for Use:
INDICATIONS
TRIBONE 80™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
TRIBONE 80™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.
When packed into a bony site, TRIBONE 80™ gradually resorbs and is replaced with bone during the healing process.
TRIBONE 80™ is to be used in association with adequate post-operative immobilization.
TRIBONE 80™ is provided sterile for single patient use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oulene Brielu Johnson
(Division Sign Off)
Rev. 9/10/2007
and Neurological De
Section 03 Page 1 of 1
510(k) Number Ko71121