Who is the manufacturer of Delphos Implants Rigid Fixation System?

Delphos Implants - Ind.Com. Importacao E Exportacao DE filed the 510(k) submission for Delphos Implants Rigid Fixation System (K182609).

What is the FDA product code for Delphos Implants Rigid 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 Delphos Implants Rigid Fixation System?

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

What are the predicate devices for Delphos Implants Rigid Fixation System?

Osteomed Modular Locking Fixation System (K080694).

Who can help prepare an FDA 510(k) submission like Delphos Implants Rigid 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.

Delphos Implants Rigid Fixation System

K182609 · Delphos Implants - Ind.Com. Importacao E Exportacao DE · JEY · Mar 29, 2019 · Dental

Device Facts

Record ID	K182609
Device Name	Delphos Implants Rigid Fixation System
Applicant	Delphos Implants - Ind.Com. Importacao E Exportacao DE
Product Code	JEY · Dental
Decision Date	Mar 29, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The Delphos Implants Rigid Fixation System implants are intended for single use only.

Device Story

Delphos Implants Rigid Fixation System consists of bone plates and screws for maxillofacial, mandibular, and orthognathic fracture fixation. Plates are manufactured from commercially pure titanium (ASTM F67/ISO 5832-2); screws from titanium alloy Ti-4Al-6V ELI (ASTM F136/ISO 5832-3). Devices are provided non-sterile; require cleaning, disinfection, and steam sterilization by the user prior to implantation. Intended for use by qualified surgeons trained in maxillofacial surgery or stomatology. System includes various plate shapes (e.g., orbital, T, straight, H, X, Z, L, Y, curved, rectangular, calvarium, maxillary, square, mentoplasty, BSSO) and screw types (self-tapping, self-drilling, emergency). Surgeons use the system to stabilize bone fractures or osteotomies; output is mechanical fixation of bone segments to facilitate healing. Benefit is restoration of skeletal structure and function in trauma or reconstructive cases.

Clinical Evidence

No clinical data. Evidence consists of bench testing: biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity per ISO 10993-5, -10, -11) and mechanical performance testing (flexural stiffness, elastic limit stress, bending moment, structural stiffness, fatigue, torsion, pullout, and thread testing per ASTM F382 and ASTM F543).

Technological Characteristics

Materials: Commercially pure titanium (ASTM F67, ISO 5832-2) for plates; titanium alloy Ti-4Al-6V ELI (ASTM F136, ISO 5832-3) for screws. Surface treatment: Anodization. Form factor: Various plate geometries and screw diameters (1.2mm-2.7mm). Sterilization: Steam sterilization (ISO 17665-1). Mechanical fixation principle. No software or electronics.

Indications for Use

Indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction in patients requiring surgical stabilization of bone segments.

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

Osteomed Modular Locking Fixation System (K080694)

Reference Devices

LeForte System Bone Plate & Screw (K112457)
Biomet Microfixation Facial Plating System (K121589)
LeForte System II (K150965)
CranioMaxillofacial Fixation (CMF) System - CMF Visionare (K180204)

Related Devices

K112457 — LEFORTE SYSTEM BONE PLATE & SCREW · Arkin Consulting Group · May 18, 2012
K182758 — MCI - CMF System · Mci Medical Concept Innovation, Inc. · Dec 5, 2019
K102641 — MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE · Neoortho Produtos Ortopedicos S/A · Dec 20, 2010
K091812 — FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS · Frontier Devices, Inc. · May 7, 2010
K953806 — SYNTHES (USA) MIDFACIAL SYSTEM · Synthes (Usa) · Mar 8, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services - USA and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. Delphos Implants - Ind.Com. Importacao e Exportacao de Implantes Medicos S.A. March 29, 2019 % Mauro Malzyner US Agent Passarini Regulatory Affairs of America, LLC 201 S. Biscayne Blvd, Suite 1200 Miami, Florida 33131 Re: K182609 Trade/Device Name: Delphos Implants Rigid Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: February 15, 2019 Received: February 25, 2019 Dear Mauro Malzyner: 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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.03.29 14:59:31 -04'00' For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K182609 Device Name Delphos Implants Rigid Fixation System Indications for Use (Describe) The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The Delphos Implants Rigid Fixation System implants are intended for single use only. | Type of Use (Select one or both, as applicable) | <table><tr><td><div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2.66663H2.66667C1.2 2.66663 0 3.86663 0 5.33329V13.3333C0 14.8 1.2 16 2.66667 16H13.3333C14.8 16 16 14.8 16 13.3333V5.33329C16 3.86663 14.8 2.66663 13.3333 2.66663ZM13.3333 13.3333H2.66667V5.33329H13.3333V13.3333ZM5.33333 8.00004L7.33333 10L10.6667 6" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2.66663H2.66667C1.2 2.66663 0 3.86663 0 5.33329V13.3333C0 14.8 1.2 16 2.66667 16H13.3333C14.8 16 16 14.8 16 13.3333V5.33329C16 3.86663 14.8 2.66663 13.3333 2.66663ZM13.3333 13.3333H2.66667V5.33329H13.3333V13.3333ZM5.33333 8.00004L7.33333 10L10.6667 6" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2.66663H2.66667C1.2 2.66663 0 3.86663 0 5.33329V13.3333C0 14.8 1.2 16 2.66667 16H13.3333C14.8 16 16 14.8 16 13.3333V5.33329C16 3.86663 14.8 2.66663 13.3333 2.66663ZM13.3333 13.3333H2.66667V5.33329H13.3333V13.3333ZM5.33333 8.00004L7.33333 10L10.6667 6" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff *PRAStaff@fda.hhs.gov* "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## ADMINISTRATIVE INFORMATION | Sponsor | Delphos Implants Industria, Comercio, Importacao e Exportacao de Implantes Medicos S.A. Estrada Manuel Correia Lopes, Parque Empresarial Progresso, Armazem 5- Cascais - Sao Domingos de Rana - Portugal 2785- 126 Telephone +351 211 955 986 | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Mauro Malzyner, Mr. US Agent Passarini Regulatory Affairs of America, LLC E-Mail: mauro@rapassarini.com.br Telephone +1 760 936 2301 | | Date Prepared | 27/Mar/2019 | | Preparer / Alternate Contact | Janine Treter Regulatory Affairs Specialist Passarini Regulatory Affairs janine@rapassarini.com.br Telephone +55 47 3804 0075 | | DEVICE NAME AND CLASSIFICATION | | | Trade/ Proprietary Name Common Name | Delphos Implants Rigid Fixation System Bone Plate | | Classification Regulations Product Code | 21 CFR 872.4760, Class II JEY | | PREDICATE DEVICE INFORMATION | | | Primary Predicate Device | K080694 - Osteomed Modular Locking Fixation System - Osteomed L.P. | | Reference Devices | K112457 - LeForte System Bone Plate & Screw - Jeil Medical Corporation K121589 - Biomet Microfixation Facial Plating System - Biomet Microfixation K150965 - LeForte System II - Jeil Medical Corporation K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare - Visionare LLC | {4}------------------------------------------------ # 510(k) Summary ## ADMINISTRATIVE INFORMATION | Sponsor | Delphos Implants Industria, Comercio, Importacao e Exportacao de Implantes Medicos S.A. Estrada Manuel Correia Lopes, Parque Empresarial Progresso, Armazem 5- Cascais - Sao Domingos de Rana - Portugal 2785- 126 Telephone +351 211 955 986 | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Mauro Malzyner, Mr. US Agent Passarini Regulatory Affairs of America, LLC E-Mail: mauro@rapassarini.com.br Telephone +1 760 936 2301 | | Date Prepared | 27/Mar/2019 | | Preparer / Alternate Contact | Janine Treter Regulatory Affairs Specialist Passarini Regulatory Affairs janine@rapassarini.com.br Telephone +55 47 3804 0075 | | DEVICE NAME AND CLASSIFICATION | | | Trade/ Proprietary Name Common Name | Delphos Implants Rigid Fixation System Bone Plate | | Classification Regulations Product Code | 21 CFR 872.4760, Class II JEY | | PREDICATE DEVICE INFORMATION | | | Primary Predicate Device | K080694 - Osteomed Modular Locking Fixation System - Osteomed L.P. | | Reference Devices | K112457 - LeForte System Bone Plate & Screw - Jeil Medical Corporation K121589 - Biomet Microfixation Facial Plating System - Biomet Microfixation K150965 - LeForte System II - Jeil Medical Corporation K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare - Visionare LLC | {5}------------------------------------------------ #### INDICATIONS FOR USE The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The Delphos Implants Rigid Fixation System implants are intended for single use only. ## SUBJECT DEVICE DESCRIPTION The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture. The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology. ### TECHNOLOGICAL CHARACTERISTICS The subject and predicate devices have a range of plates and screws with equivalent indication for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. Differences in the design features between the subject devices and the primary predicate device K080694 are addressed by comparison to the reference devices as listed in the tables below. {6}------------------------------------------------ #### INDICATIONS FOR USE The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The Delphos Implants Rigid Fixation System implants are intended for single use only. ## SUBJECT DEVICE DESCRIPTION The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture. The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants. The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in maxillofacial surgery and/or stomatology. ### TECHNOLOGICAL CHARACTERISTICS The subject and predicate devices have a range of plates and screws with equivalent indication for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. Differences in the design features between the subject devices and the primary predicate device K080694 are addressed by comparison to the reference devices as listed in the tables below. {7}------------------------------------------------ | Table 5.1: Substantial Equivalence on Plates | | | | | | | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | REFERENCE DEVICE III | | | Trade Name Information | K182609 - Delphos Implants Rigid Fixation System | K080694 - Osteomed Modular Locking System | K112457 - LeForte System Bone Plate & Screw | K121589 - Biomet Microfixation Facial Plating System | K180204 - Mini and Micro Fragments Reconstruction System - CMF Visionare | Substantial Equivalence Discussion | | | Delphos Implants - Ind. Com. Importação e Exportação de Implantes Médicos S.A. | OsteoMed L. P. | Jeil Medical Corporation | Biomet Microfixation | Visionare LLC | | | | | | | | | Equivalent The subject device indication for use is identical to primary predicate device excepting for the reference to drills and the reference to the term "cranio-maxillofacial". Drills are surgical instruments | | | | | | | | developed to assist in the installation of plates and screws and are not subject of this submission. Therefore, information on drills were suppressed from Delphos Implants indications for use Statement. | | Indication for Use | The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. | The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only. | Intended for use in Selective trauma of the mid-face, reconstruction procedures and selective orthognathic surgery of the maxilla and chin. | These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures 2. Osteotomies 3. Reconstructive procedures 4. Revision procedures where other treatments or devices have failed | CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin. | In a previous submission from Delphos Implants (K172949), FDA informed that devices intended for Cranial/Neuro applications are to be reviewed by the Neurology Panel. Therefore, the words cranio- maxillofacial were replaced by maxillofacial. | | | The Delphos Implants Rigid Fixation System implants are intended for single use only. | | | | | The subject device indication for use are within the scope of the reference devices. | | | | | | | | Identical | | Product Code | JEY | JEY | JEY, DZL | JEY, HWC | JEY, DZL | to Primary Predicate Device and within the scope of Reference Devices. | | Class | II | II | II | II | II | Identical | | Trade Name Information | SUBJECT DEVICES K182609 - Delphos Implants Rigid Fixation System Delphos Implants - Ind. Com. Importação e Exportação de Implantes Médicos S.A. | PRIMARY PREDICATE DEVICE K080694 - Osteomed Modular Locking System OsteoMed L. P. | REFERENCE DEVICE I K112457 - LeForte System Bone Plate & Screw Jeil Medical Corporation | REFERENCE DEVICE II K121589 - Biomet Microfixation Facial Plating System Biomet Microfixation | REFERENCE DEVICE III K180204 - Mini and Micro Fragments Reconstruction System - CMF Visionare Visionare LLC | Substantial Equivalence Discussion | | Regulation Number | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 21 CFR 872.4880 | 21 CFR 872.4760 21 CFR 888.3040 | 21 CFR 872.4760 21 CRF 872.4880 | Identical to Primary Predicate Device and within the scope of Reference Devices. | | Regulation Name | Bone Plate | Bone Plate | Bone Plate Intraosseus fixation screw or wire | Bone Plate Screw, Fixation, Bone | Bone Plate Intraosseus fixation screw or wire | Identical to Primary Predicate Device and within the scope of Reference Devices. | | Raw material | The plates are made from commercially pure titanium (ASTM F67) | The plates are made from Titanium Alloy (ASTM F136 or commercially pure titanium (ASTM F67) | The plates are made from commercially pure titanium (ASTM F67) | The plates are made from Titanium Alloy (ASTM F136 or commercially pure titanium (ASTM F67) | The plates are made from commercially pure titanium (ASTM F67) | Equivalent The subject device raw materials are within the scope of the predicates raw materials. | | Surface treatment | Anodization | Anodization | Anodization | Not informed | Not informed | Identical | | Use | Single use | Single use | Single use | Single use | Single use | Identical | | Sterilization | Non-sterile, Steam sterilization prior to use | Non-sterile, Steam sterilization prior to use | Non-sterile, Steam sterilization prior to use | Not informed | Non-sterile, Steam sterilization prior to use | Identical | | Plates thickness | 0.5, 0.6, 0.7, 0.8, 1.0, 1.3, 1.6, 2.5 mm | 0.25mm ~ 2.5mm 1.0mm ~2.5mm | 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.8mm, 1.0mm, 1.3mm, 2.5mm | Various | 0.3mm, 0.7mm, 1.0mm, 1.5mm, 2.0mm, 2.54mm. | Equivalent The plates thickness are within the range of the predicate devices. | | | | | | | | | | | SUBJECT DEVICES | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE I | REFERENCE DEVICE II | REFERENCE DEVICE III | | | Trade Name Information | K182609 - Delphos I…