Who is the manufacturer of MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

Medcad filed the 510(k) submission for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System (K230398).

What is the FDA product code for MedCAD® AccuPlate® 3DTi Patient-Specific Plating 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 MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

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

What are the predicate devices for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

KLS Martin Individual Patient Solutions (K191028).

Who can help prepare an FDA 510(k) submission like MedCAD® AccuPlate® 3DTi Patient-Specific Plating 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.

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

K230398 · Medcad · JEY · Sep 26, 2023 · Dental

Device Facts

Record ID	K230398
Device Name	MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Applicant	Medcad
Product Code	JEY · Dental
Decision Date	Sep 26, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.

Device Story

Device is patient-specific metal bone plate for maxillofacial, midface, and non-continuity mandibular fixation. Input: patient anatomical data (CT, CBCT, or MRI) and surgeon-provided design parameters. Transformation: additive manufacturing (3D printing) of Ti-6AL-4V ELI titanium alloy based on patient-specific anatomical geometry. Output: non-sterile, single-use custom plate. Used in clinical settings by surgeons; plates are not intended for intraoperative bending. Healthcare providers use plates with commercially available non-locking bone screws to stabilize bone segments. Benefits include patient-specific fit for reconstruction and fixation, potentially improving surgical outcomes compared to generic plates.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing: static and dynamic bending (ASTM F382), axial screw pushout (ASTM F543), and fit/form validation against surgical plans. Biocompatibility per ISO 10993-1/5 and sterilization validation per ISO 17665-1/2 (SAL 10^-6) confirm safety.

Technological Characteristics

Material: Ti-6AL-4V ELI titanium alloy (Grade 23) per ASTM F136. Manufacturing: Additive (3D printing). Form factor: Patient-specific geometry. Connectivity: None. Sterilization: Steam (SAL 10^-6). Software: Patient-specific design process (same as K192282).

Indications for Use

Indicated for stabilization, fixation, and reconstruction of maxillofacial, midface, and mandibular skeletal regions in adolescents (>12 to 21 years) and adults.

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

KLS Martin Individual Patient Solutions (K191028)

Reference Devices

Walter Lorenz Surgical, Inc. Lorenz System (K953385)
KLS Martin Individual Patient Solutions (K210731)
Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System (K203282)
Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System (K170272)
MedCAD® AccuPlan® System (K192282)

Related Devices

K193280 — MedCAD® AccuPlate® Patient-Specific Plate · Medcad · Feb 12, 2021
K163579 — KLS Martin Individual Patient Solutions · KLS Martin L.P. · Nov 21, 2017
K191028 — KLS Martin Individual Patient Solutions · KLS-Martin L.P. · Nov 22, 2019
K122647 — SYNTHES PATIENT SPECIFIC PLATE · Synthes, Inc. · Feb 28, 2013
K222650 — Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate · Stryker Craniomaxillofacial (Cmf) · Dec 9, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 9/26/23 MedCAD % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickorv Flat Highway Suite 120 Woodstock, Georgia 30188 Re: K230398 Trade/Device Name: MedCAD® AccuPlate® 3DTi Patient-Specific Plating System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 28, 2023 Received: August 28, 2023 Dear Justin Gracyalny: 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 (the 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. 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Sherrill L'athrop Blitzer for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices {2}------------------------------------------------ Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230398 Device Name MedCAD® AccuPlate® 3DTi Patient-Specific Plating System Indications for Use (Describe) The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| |--------------------------------------------------------------------------------------|----------------------------------------------------------------------| #### 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." {4}------------------------------------------------ ## K230398 510(k) SUMMARY: | Date Prepared | September 26, 2023 | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor Contact | MedCAD 501 S 2nd Ave, Suite A-1000 Dallas, TX 75226 (214) 453-8864 | | 510(k) Contact(s) | Secure BioMed Evaluations Justin Gracyalny, MSE Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com | | Trade Name | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | | Code – Classification | Classification Name: Bone Plate (21 CFR 872.4760) Regulatory Class: II Product Code: JEY | | Primary Predicate | K191028 KLS Martin Individual Patient Solutions | | Reference Devices | K953385 Walter Lorenz Surgical, Inc. Lorenz System K210731 KLS Martin Individual Patient Solutions K203282 Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System K170272 Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System K192282 MedCAD® AccuPlan® System | | Device Description | The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non- sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone | | Indications for Use Statement | The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults. | ## MedCAD® AccuPlate® 3DTi Patient-Specific Plating System from 3.5mm to 22mm. screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging {5}------------------------------------------------ ## Comparison of Technological Characteristics The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is substantially equivalent to and are as safe and effective as its predicate device (K191028 KLS Martin Individual Patient Solutions). Table 1 compares the subject, predicate, and reference devices. ## Similarities to Predicate The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicate / reference devices. The principles of operation and technological characteristics are either identical or substantially equivalent to the predicate / reference devices. The system has similar technological characteristics including: - The subject device and the predicate / reference devices have hole features to accommodate ● commercially available non-locking fixation screws. - . The subject device uses the same patient specific design software and process flow as the reference device (K192282). - . The subject device design envelope is similar to the predicate / reference devices (K191028, K210731, K203282, K170272). - The subject device has equivalent mechanical performance to the reference device ● (K953385). - Sterility assurance level of 1x10-6 ## Differences to Predicate The following differences exist between the subject and predicate devices: - The subject and predicate device may both be additively manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F136. However, the primary predicate device may also be subtractively manufactured from commercially pure titanium per ASTM F67. The absence of this design configuration does not raise new concerns for substantial equivalence. - The subject device is indicated for both adolescents (greater than 12 to 21 years of age) and adults while the patient population in the predicate device is not specified. The use of patient specific facial implants in adolescent populations in identical to that seen in the reference devices (K210731, K170272). As such, this difference does not raise new concerns for substantial equivalence. - . The predicate device includes mandibular plates for treatment of continuity mandibular defects while the subject device is only intended to treat non-continuity mandibular defects. This difference is addressed via a design envelope appropriate for the intended use and labeling. As such, this difference does not raise new concerns for substantial equivalence. {6}------------------------------------------------ ## Biocompatibility Testing Biocompatibility testing was conducted in accordance with international standard ISO 10993-1. ISO10993-5, and FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the plates and their intended use. ### Sterilization Validation A sterilization validation was conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" to a sterility Assurance Level (SAL) of 10th All test method acceptance criteria were met. ### Non-Clinical Performance Testing Performance testing for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is summarized below: - Static and Dynamic Bending per ASTM F382 The subject device was shown to have . equivalent bending strength and fatigue life as the reference device (K953385). - Axial Screw Pushout per ASTM F543 The subject device plate / screw interface was . shown to have equivalent axial screw pushout strength as the reference device (K953385). - . Fit and Form Validation – The subject device patient specific design process was shown to produce devices that aligned with the approved surgical plan. ### Conclusions Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device. {7}------------------------------------------------ # Table 1 – Comparison of Technological Characteristics | Trait | Proposed Subject Device MedCAD AccuPlate® 3DTi Patient-Specific Plate | Primary Predicate Device KLS Martin Individual Patient Solutions K191028 | Reference Device Walter Lorenz Surgical, Inc. Lorenz System K953385 | Reference Device KLS Martin Individual Patient Solutions K210731 | Reference Device Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System K203282 | Reference Device Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System K170272 | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Purpose | Subject Device | Same Indications | Similar Dimensions and Performance | Similar Dimensions and Patient Population | Similar Dimensions (Midface Hole Spacing) | Similar Dimensions (Orbital Plate Thickness) | | Product Code | JEY | JEY | JEY | JEY | JEY | JEY | | Device Class | Class II | Class II | Class II | Class II | Class II | Class II | | Regulation | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | 21 CFR 872.4760 | | Indications for Use | The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults. | KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions. | 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 | KLS Martin Individual Patient Solutions (IPS) is intended as a pre-operative software tool for simulating / evaluating surgical treatment options as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS software and the result is an output data file that may then be provided as digital models or used as input in an additive manufacturing portion of the system that produces physical outputs including implants, anatomical models, guides, splints, and case reports for use in maxillofacial, midface, & mandibular surgery. KLS Martin Individual Patient Solutions (IPS) implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in children (2 years of age to < 12 years of age), adolescents (12 years of age - 21 years of age), and adults. | TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions. | The TruMatch CMF Titanium 3D Printed Implant System is intended for bone repositioning, fixation and reconstruction of the maxillofacial skeleton, midface, mandible and chin in adolescents (greater than 12 to 21 years of age) and adults. Specific indications for use: ● Orthognathic surgery ● Reconstructive mandible and maxillofacial surgery ● Mandible and maxillofacial trauma surgery. | | Sterility | Provided non-sterile Steam Sterilized SAL 10-6 | Provided non-sterile Steam Sterilized SAL 10-6 | Provided non-sterile Steam Sterilized SAL 10-6 | Provided non-sterile Steam Sterilized SAL 10-6 | Provided non-sterile Steam Sterilized SAL 10-6 | Provided non-sterile Steam Sterilized SAL 10-6 | | Patient Population | Adolescents (12 - 21 years of age) Adults (21+ years of age) | Unknown | Unknown | Children (2 - 12 years of age) Adolescents (12 - 21 years of age) Adults (21+ years of age) | Unknown | Adolescents (12 - 21 years of age) Adults (21+ years of age) | | Trait | Proposed Subject Device MedCAD AccuPlate® 3DTi Patient-Specific Plate | Primary Predicate Device KLS Martin Individual Patient Solutions K191028 | Reference Device Walter Lorenz Surgical, Inc. Lorenz System K953385 | Reference Device KLS Martin Individual Patient Solutions K210731 | Reference Device Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System K203282 | Reference Device Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System K170272 | | Physical Shape | Patient Specific Criteria (manufactured to final geometry) | Patient Specific Criteria (manufactured to final geometry) | Patient Specific Criteria (bent to final geometry during surgery) | Patient Specific Criteria (manufactured to final geometry) | Patient Specific Criteria (manufactured to final geometry) | Patient Specific Criteria (manufactured to final geometry) | | Anatomical Locations | • Orbital • Midface / Maxillofacial • Mandible | • Orbital • Midface / Maxillofacial • Mandible | • Orbital • Midface / Maxillofacial • Mandible | • Orbital • Midface / Maxillofacial • Mandible | • Midface / Maxillofacial • Mandible | • Orbital • Midface / Maxillofacial • Mandible | | Material | Ti-6AL-4V Extra Low Interstitial (ELI) Titanium Alloy (Grade 23) per ASTM F136 | Surgical Guides: Epoxy/Acrylic Resins Implants: Commercially Pure Titanium per ASTM F67 or Ti-6AL-4V ELI per ASTM F136Commercially Pure Titanium per ASTM F67 | Commercially Pure Titanium per ASTM F67 | Surgical Guides: Epoxy/Acrylic Resins Implants: Commercially Pure Titanium per ASTM F67 or Ti-6AL-4V ELI per ASTM F136 | Commercially Pure Titanium per ASTM F67 | Commercially Pure Titanium per ASTM F67 | | Manufacturing Method | 3D Printed (Additive Manufacturing) | Traditional (Subtractive) 3D Printed (Additive Manufacturing) | Traditional (Subtractive) | Traditional (Subtractive) 3D Printed (Additive Manufacturing) | Traditional (Subtractive) | 3D Printed (Additive Manufacturing) | | Plate Thickness | Orbital: 0.6mm - 1.2mm Maxillofacial / Midface: 0.8mm - 2.0mm Mandibular (Non-Continuity Defects): 0.8mm - 2.0mm | Orbital: 0.3mm - 1.0mm Maxillofacial / Midface: 0.6mm - 10mm Mandibular Reconstruction: 1.0mm - 3.0mm | 0.2mm - 2.6mm | Orbital: 0.3mm - 1.0mm Maxillofacial / Midface: 0.6mm - 10mm Mandibular (Non-Continuity Defects): 0.6mm - 10mm Mandibular (Continuity Defects): 2.0mm - 10mm | Maxillofacial / Midface : 0.6 mm - 2.0 mm Mandibular: 2.0 mm - 3.0 mm | Orbital: 0.8mm - 1.2mm Maxillofacial / Midface: 0.8mm - 3.0mm Mandibular: 0.8mm - 3.0mm | | Trait | Proposed Subject Device MedCAD AccuPlate® 3DTi Patient-Specific Plate | Primary Predicate Device KLS Martin Individual Patient Solutions K191028 | Reference Device Walter Lorenz Surgical, Inc. Lorenz System K953385 | Reference Device KLS Martin Individual Patient Solutions K210731 | Reference Device Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System K203282 | Reference Device Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System K170272 | | Plate Width | Orbital: Min: ≥ 3.9 mm (around screw holes) Min: ≥ 2.5 mm (not around screw hole) Maxillofacial / Midface: Min: ≥ 4.5 mm (around screw holes) Min: ≥ 2.5 mm (not around screw hole) | Maxillofacial / Midface: Min: ≥ 4.5 mm (around screw holes) Min: ≥ 3 mm (not around screw hole) Max: Dependent on screw-hole Mandibular: Min: 7 mm Min: 8.5mm | Unknown | Orbital: Min: ≥ 3.5 mm (around screw holes) Min: ≥ 2.2 mm (not around screw hole) Maxillofacial / Midface: Min: ≥ 4.5 mm (around screw holes) Min: ≥ 2.2 mm (not around screw hole) | Maxillofacial / Midface: Min: ≥ 4.5 mm (around screw holes) Min: ≥ 3 mm (not around screw hole) Mandibular: Min: 6.63 mm Max: 16 mm | Orbital: 0.6mm - 1.2mm Maxillofacial / Midface: 0.8mm - 2.0mm Mandibular (Non-Continuity Defects): 0.8mm - 2.0mm | | | Mandibular (Non-Continuity Defect): Min: ≥ 4.5 mm (around screw holes) Min: ≥ 2.5 mm (not around screw hole) | | | Mandibular (Non-Continuity Defect): Min: ≥ 4.5 mm (around screw holes) Min: ≥ 2.2 mm (not around screw hole) Mandibular (Continuity Defect): Min: ≥ 6.4 mm (around screw holes) Min: ≥ 3.2 mm (not around screw hole) | | | | Number of Holes | Orbital, Mandibular, Maxillofacial / Midface: Min: ≥2 per side of defect Max: Dependent on length & hole spacing | Orbital & Maxillofacial / Midface: Min: ≥ 2 per side of defect Max: Dependent on length & hole spacing Mandibular: Min: 4 Max: Dependent on length & hole spacing | Unknown | Orbital, Mandibular, Maxillofacial / Midface: ≥ 2 per side of defect | Maxillofacial/midface: Min: ≥ 2 per side of defect Max: Dependent on length & hole spacing Mandibular: Min: 4 Max: Dependent on length & hole spacing | Unknown | | Hole Spacing | Orbital: ≥4.0mm Maxillofacial / Midface: ≥4.0mm Mandibular (Non-Continuity Defects): ≥4.5mm | Orbital & Maxillofacial / Midface: ≥4.5mm Mandibular: ≥8.0mm | Unknown | Orbital: ≥3.5mm Maxillofacial / Midface: ≥4.5mm Mandibular (Non-Continuity Defects): ≥4.5mm Mandibular (Continuity Defects): ≥6.4mm | Maxillofacial: ≥ 4.5 mm Midface: ≥ 4.0 mm Mandibular: ≥ 8 mm | Unknown | | Trait | Proposed Subject Device MedCAD AccuPlate® 3DTi Patient-Specific Plate | Primary Predicate Device KLS Martin Individual Patient Solutions K191028 | Reference Device Walter Lorenz Surgical, Inc. Lorenz System K953385 | Reference Device KLS Martin Individual Patient Solutions K210731 | Reference Device Industrias Medicas Sampedro S.A.S. TECHFIT Patient-Specific Maxillofacial System K203282 | Reference Device Materialize N.V. TruMatch CMF Titanium 3D Printed Implant System K170272 | | Plate Length | Orbital: 16mm - 50m Maxillofacial / Midface: 18mm - 350mm Mandibular (Non-Continuity Defects): 18mm - 350mm | Orbital & Maxillofacial / Midface: 18 - 350mm Mandibular: 31 - 320mm | Unknown | Orbital: 10.5mm - 50m Maxillofacial / Midface: 18mm - 350mm Mandibular (Non-Continuity Defects): 18mm - 350mm Mandibular (Continuity Defects): 25mm - 350mm | Maxillofacial / Midface: 18mm - 350mm Mandibular: 78mm - 320mm | Orthognathic: 20mm maximum advancement Orbital: 5.5mm - 45mm Maxillofacial / Midface / Mandibular: 20 mm maximum bridging of osteotomy gap; Small: 20- 120mm, Large: 20-294mm | | Plate Holes | No locking threads | Locking threads optional | Locking threads optional | Locking threads optional | Unknown…