(170 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of physical components (screws, mesh, drivers). There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for stabilization and fixation of bone grafts and other materials to regenerate bone, rather than directly treating a disease or condition for therapeutic purposes.
No
The device is described as a fixation system for bone grafts and membranes, which are used to regenerate bone. Its purpose is to stabilize and fix materials, not to diagnose a condition or disease.
No
The device description explicitly details physical components made of titanium alloy, including screws, drivers, and mesh, which are hardware.
Based on the provided information, the TriStar Bone Graft Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The TriStar Bone Graft Fixation System is a system of physical implants (screws and mesh) and tools used to stabilize and fix bone grafts and other materials within the oral cavity. It is a surgical device used for structural support and regeneration, not for analyzing biological samples.
The description clearly indicates it's a device for surgical implantation and fixation, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.
Product codes (comma separated list FDA assigned to the subject device)
JEY, DZL
Device Description
The TriStar Bone Graft Fixation System consists of titanium alloy self-drilling screws which are tapered and have a maximum diameter of 1.75mm with lengths of 3mm, 4mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, and 24mm. The screws are manufactured using a Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes a number of accessories used to fixate the screws and/or membranes or bone blocks to the host bone including a square headed morse tapered hand screw driver, screw driver handle, and latch type driver. The system includes titanium mesh in 40mm x 60mm or 18mm x 25mm sizes each having a thickness of 0.1mm. The screws and titanium mesh are designed to be removed from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-clinical performance testing has been conducted using ASTM F543-13 – Standard Specification and Test Methods for Metallic Medical Bone Screws. Mesh was tested under ASTM F382. Tests from these standard were also conducted on the predicate devices. Clinical testing is not applicable to this device. Biocompatibility of the patient contacting titanium devices has been tested under ISO 10993-5 and found to be biocompatible.
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.
K073342, K091812, K030806, K972463, K022890, K063769
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.
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
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other, with a ribbon-like element flowing beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18.2014
Impladent, Ltd. Maurice Valen President 198-45 Foothill Ave. Holliswood, New York 11423
Re: K141764
Trade/Device Name: TriStar Bone Graft Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY, DZL Dated: November 18, 2014 Received: November 19, 2014
Dear Mr. Valen:
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. 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
Page 2 - Mr. Valen
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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, mA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
2
Premarket Notification 510(k) Submission
Indications for Use
K141764 510(k) Number: N/A
Device Name: TriStar Bone Graft Fixation System
Indications for Use:
The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.
Prescription Use YES
(Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter NO
(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/0 description: The image shows the logo for IMPLADENT LTD. The logo consists of a black geometric shape on the left and the company name in red on the right. Below the company name is the address "198-45 Foothill Avenue, Holliswood NY 11423".
510(k) Summary
| Type of Submission: | Traditional Premarket Notification 510(k), 21 CFR 807.92 | |
|---|---|---|
| Submitted by: | Impladent Ltd. | |
| 198-45 Foothill Avenue | ||
| Holliswood NY 11423-1611 | ||
| Contact Person: | Maurice Valen, President; Director of R&D | |
| Andrew Valen, Vice President | ||
| Phone: 718 465-1810 Fax: 718 464-9620 | ||
| Email: maurice@impladentltd.com | ||
| cc: andrew@impladentltd.com | ||
| Establishment Registration: | 2431866 | |
| Common Name: | Titanium Fixation Screw System | |
| Proprietary Name: | TriStar Bone Graft Fixation System | |
| Classification: | Class II, 21 CFR 872.4760 | |
| Product Code: | JEY | |
| Review Panel: | Dental | |
| Confidentiality: | Under section 21 CFR 807.95, selected pages and/or sections | |
| have been marked as "CONFIDENTIAL" | ||
| Purpose of Submission: | New device. Evidence herein is submitted to establish | |
| substantial equivalence for the TriStar Bone Graft Fixation | ||
| System | ||
| Predicate Devices Screws: | Salvin Titanium Fixation Screw System (K073342) | |
| Frontier Devices Maxillofacial and Mesh System (K091812) | ||
| BioPlate Rigid Fixation Bone Plating System for | ||
| Craniomaxillofacial Surgery (K030806, K972463, K022890) | ||
| Alpha-Bio Tec Bone Fixation Screw System (K063769) | ||
| Predicate Devices Mesh: | Unicare Biomedical Cytoflex Mesh (K021511) |
4
510(k) Summary
Device Description:
The TriStar Bone Graft Fixation System consists of titanium alloy self-drilling screws which are tapered and have a maximum diameter of 1.75mm with lengths of 3mm, 4mm, 5mm, 6mm, 8mm, 10mm, 12mm, 15mm, 18mm, 21mm, and 24mm. The screws are manufactured using a Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes a number of accessories used to fixate the screws and/or membranes or bone blocks to the host bone including a square headed morse tapered hand screw driver, screw driver handle, and latch type driver. The system includes titanium mesh in 40mm x 60mm or 18mm x 25mm sizes each having a thickness of 0.1mm. The screws and titanium mesh are designed to be removed from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single use only.
Indications for Use:
The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity.
Technological Characteristics & Substantial Equivalence
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the FDA for commercial distribution. Engineering drawings, labeling, advertising materials and mechanical testing have been submitted and demonstrate that the subject device is substantially equivalent to its predicate devices in terms of design, material composition, indications for use, standards applied and other characteristics. There are no unique applications, indications, materials or specifications for the TriStar Bone Graft Fixation System when compared to the predicate devices.
5
Testing
Non-clinical performance testing has been conducted using ASTM F543-13 – Standard Specification and Test Methods for Metallic Medical Bone Screws. Mesh was tested under ASTM F382. Tests from these standard were also conducted on the predicate devices. Clinical testing is not applicable to this device. Biocompatibility of the patient contacting titanium devices has been tested under ISO 10993-5 and found to be biocompatible.
Conclusion
Based on the 510(k) Summary and the information provided in this submission, we conclude that the TriStar Bone Graft Fixation System is substantially equivalent to the existing legally marketed devices cited above and where minor differences exist, these differences raise no new safety, effectiveness and/or performance issues.
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Substantial Equivalence Predicate Device Table - Screws
| Device | TriStar Bone
Graft Fixation
System | Salvin Dental
Specialties
Titanium
Fixation Screw
System | Frontier
Devices
Maxillofacial
and Mesh
System | BioPlate Rigid
Fixation Bone Plating
System for
Craniomaxillofacial
Surgery | Alpha-Bio Tec
Bone Fixation
Screw System |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K141764 | K073342 | K091812 | K030806, K972463,
K022890 | K063769 |
| Applicant Name | Impladent Ltd. | Salvin Dental
Specialties | Frontier
Devices | BioPlate | Alpha-Bio |
| Year 510(k)
Cleared | 2014 | 2008 | 2010 | 1997, 2002, 2003 | 2007 |
| Screw Design | Self-Drilling | Self-Tapping | Self-Drilling &
Self-Tapping | Self-Drilling | Self-Tapping |
| Screw Material | Ti-6Al-4V
(ASTM F-136) | Ti-6Al-4V | Ti-6Al-4V
(ASTM F-136) | Ti-6Al-4V | Ti-6Al-4V
(ASTM F-136) |
| Head
Configuration | Square | Cross | Cross | Square | Hexagonal |
| Screw Length | 3mm - 24mm | 4mm – 15mm | 3mm - 24mm | 3mm - 10mm | 4mm – 12mm |
| Screw Diameter | 1.75mm max | 1.5 & 2.0 mm | 1.5 – 2.3 mm | 1.5, 1.8, 1.9, 2.3 mm | 1.2, 1.6mm |
| Mesh Offered | Yes | Yes | Yes | Yes | No |
| Plates Offered | No | No | Yes | Yes | No |
| Bench Testing | ASTM F-543 | ASTM F-543 | Not Specified | Not Specified | Not Specified |
| Indications for
Use | The TriStar Bone
Graft Fixation
System is indicated
for stabilization and
fixation of bone
grafts, bone blocks,
bone filling
materials, and / or
barrier membranes
used to regenerate
bone in the oral
cavity. | The Salvin Dental
Specialties, Inc.
Titanium Fixation
Screw is intended for
use in internal
fixation of small
bones including the
craniofacial and
maxillofacial skeleton
affected by trauma,
or for reconstruction. | Frontier Devices
Maxillofacial System
is intended for use in
selective trauma of
the mid-face and
maxillofacial
skeleton;
maxillofacial surgery;
reconstructive
procedures; and
selective
orthognathic surgery
of the maxilla and
chin. | The Bioplate Rigid Fixation
Bone Plating System for
Craniomaxillofacial Surgery is
intended for use in the
treatment of fractures and
reconstructive procedures of
the Craniomaxillofacial
skeleton and non-weight
bearing fixation, including
cranial bone fixation, brow
fixation, and orbital fixation.
Each device is intended for
single use only and only in
conjunction with other
titanium and titanium alloy
implants. | The Alpha-Bio
Bone Fixation
Screw System is
indicated to
stabilize and fixate
bone grafts, bone
filling materials,
and/or barrier
membranes used
for regeneration of
bone in the oral
cavity. |
| Marketed As Kit | Yes | Yes | Yes | Yes | Yes |
| Items in Kit | Screws
Handle
Driver
Mesh | Cassette
Screws
Handle
Driver
Drill
Additional Drill | Cassette
Screws
Handle
Driver
Mesh
Mesh Cutter
Ti-Plates | Cassette
Screws
Handle
Driver
Foreceps
Ti-Plates | Screws
Driver
Drill |
| Sterilization | Steam | Steam | Steam | Steam | n/a |
| Product Code /
Regulation # | JEY
872.4760 | DZL
872.4880 | DZL
872.4880 | JEY
872.4760 | DZL
872.4880 |
7
| Device | TriStar Bone Graft Fixation System
Titanium Mesh | Unicare Biomedical
Cytoflex Mesh |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K141764 | K021511 |
| Classification | JEY | JEY |
| Material | Grade 1 Titanium | Commercially Pure Titanium |
| Specification | Bending tests as per ASTM F 382-99
(R2008) | Bending tests as per ASTM F 382-99
(R2008) |
| Dimensions | (1) 18 x 25 mm
(2) 40 x 60 mm | (1) 25 x 30mm |
| Thickness | 0.1 mm | 0.1 mm |
| Size of holes | 0.8 mm | 0.5 mm |
| Biocompatibility | Cytotoxicity | Unknown |
| Indications | Stabilization and fixation of bone
grafts, bone blocks, bone filling
materials, and / or barrier membranes
used to regenerate bone in the oral
cavity.
[These are the same indications as kit
overall] | Used to ensure three dimensional
reconstruction of alveolar bone
defects and to facilitation
augmentation with adequate fixation
of the augmentation material. |