Who is the manufacturer of TRISTAR BONE GRAFT FIXATION SYSTEM?

Impladent , Ltd. filed the 510(k) submission for TRISTAR BONE GRAFT FIXATION SYSTEM (K141764).

What is the FDA product code for TRISTAR BONE GRAFT FIXATION SYSTEM?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TRISTAR BONE GRAFT FIXATION SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TRISTAR BONE GRAFT FIXATION SYSTEM?

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); Unicare Biomedical Cytoflex Mesh (K021511).

Who can help prepare an FDA 510(k) submission like TRISTAR BONE GRAFT FIXATION SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TRISTAR BONE GRAFT FIXATION SYSTEM

K141764 · Impladent , Ltd. · JEY · Dec 18, 2014 · Dental

Device Facts

Record ID	K141764
Device Name	TRISTAR BONE GRAFT FIXATION SYSTEM
Applicant	Impladent , Ltd.
Product Code	JEY · Dental
Decision Date	Dec 18, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

TriStar Bone Graft Fixation System comprises titanium alloy (Ti-6Al-4V) self-drilling screws and titanium mesh; used for stabilization/fixation of bone grafts, bone blocks, bone filling materials, or barrier membranes in the oral cavity. System includes manual surgical instruments: square-headed morse tapered screwdriver, driver handle, and latch-type driver. Used by clinicians in oral surgery settings. Screws and mesh are non-sterile, single-use, and intended for removal after sufficient bone regeneration. Device provides mechanical fixation to host bone to facilitate bone regeneration; clinical benefit is stabilized graft/membrane placement during healing.

Clinical Evidence

Bench testing only. Mechanical performance testing conducted per ASTM F543-13 (screws) and ASTM F382 (mesh). Biocompatibility testing performed per ISO 10993-5.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ASTM F-136) for screws; Grade 1 Titanium for mesh. Screws: self-drilling, tapered, max 1.75mm diameter, 3-24mm lengths. Mesh: 0.1mm thickness. Accessories: manual drivers. Sterilization: steam (non-sterile supply). Connectivity: none.

Indications for Use

Indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and/or barrier membranes for bone regeneration in the oral cavity.

Regulatory Classification

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.

Predicate Devices

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)
Unicare Biomedical Cytoflex Mesh (K021511)

Related Devices

K171831 — Intra-Lock Bone Fixation System · Intra-Lock International, Inc. · Oct 26, 2017
K222367 — SAVE GBR · Dentis Co., Ltd. · Mar 23, 2023
K161857 — Salvin Tenting Screw System · Salvin Dental Specialties · Apr 28, 2017
K063769 — ALPHA BIO BONE FIXATION SCREW SYSTEM · Alpha-Bio Tec , Ltd. · Mar 30, 2007
K050669 — JEIL BONE FIXATION SYSTEM · Jeil Medical Corporation · May 26, 2005

Submission Summary (Full Text)

{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 {3}------------------------------------------------ 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". www.impladentltd.com #### 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. {6}------------------------------------------------ # 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. | # Substantial Equivalence Predicate Device Table - Mesh