Who is the manufacturer of Medicon Epiplating System?

Cmf Medicon Surgical, Inc. filed the 510(k) submission for Medicon Epiplating System (K241253).

What is the FDA product code for Medicon Epiplating System?

FZE. It is classified under 21 CFR 878.3680 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Medicon Epiplating System?

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

Who can help prepare an FDA 510(k) submission like Medicon Epiplating 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.

Medicon Epiplating System

Q: What are the predicate devices for Medicon Epiplating System?

Osseointegrated Fixtures (K161548).

K241253 · Cmf Medicon Surgical, Inc. · FZE · Dec 12, 2024 · General, Plastic Surgery

Device Facts

Record ID	K241253
Device Name	Medicon Epiplating System
Applicant	Cmf Medicon Surgical, Inc.
Product Code	FZE · General, Plastic Surgery
Decision Date	Dec 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.3680
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

Device Story

Medicon Epiplating System consists of titanium plates and screws used as foundation for anchoring external craniofacial prostheses (epitheses). Device provides bone anchorage via osseointegration. Used in clinical settings by surgeons; manual insertion performed using specialized tools. System accommodates various anatomical needs through multiple plate/screw sizes. Output is a stable, osseointegrated anchor point for external prosthetics; enables secure attachment of facial restorations; improves patient quality of life by restoring physical defects. No software or electronic components.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F382, including proof of load, bending strength, and bending stiffness on worst-case implants. Sterilization validated per ANSI/AAMI/ISO 17665-1:2006/(R)2013. Cleaning validated per AAMI TIR30:2011. Biocompatibility supported by previously cleared devices with identical materials and manufacturing methods tested per ISO 10993-1.

Technological Characteristics

Materials: Pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136). Principle: Permanent fixation via osseointegration. Form factor: Plates and screws in various shapes/sizes. Connectivity: None. Sterilization: Unsterile delivery, validated for pre-vacuum steam sterilization. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for patients requiring attachment of external restoration prostheses for physical defects in the maxillo-craniofacial region (ear, nose, eye) when other attachment methods are inadequate.

Regulatory Classification

Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Predicate Devices

Osseointegrated Fixtures (K161548)

Reference Devices

TITANIUM MINIPLATE SYSTEM (K951690)
CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM (K951691)
Epitec™ Titanium Implant System (K961719)

Related Devices

K060492 — AESCULAP CRANIOFACIAL PLATE AND SCREW · Aesculap, Inc. · Apr 7, 2006
K973145 — TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM · Sofamor Danek USA,Inc. · Nov 19, 1997
K961719 — EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES · Howmedica Leibinger, Inc. · Jul 17, 1997
K073307 — MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM · Bio-Technology USA, Inc. · Oct 29, 2008
K091812 — FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS · Frontier Devices, Inc. · May 7, 2010

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) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure. December 12, 2024 CMF Medicon Surgical Inc. Matthias Alber Executive Vice President 11200 St. Johns Industrial Pkwy N. Ste. 1 Jacksonville, Florida 32246 Re: K241253 Trade/Device Name: Medicon Epiplating System Regulation Number: 21 CFR 878.3680 Regulation Name: Nose Prosthesis Regulatory Class: Class II Product Code: FZE Dated: May 3, 2024 Received: September 13, 2024 Dear Matthias Alber: 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 (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. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. 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). {2}------------------------------------------------ Sincerely, Alicia Hemphill -S Digitally signed by Alicia Hemphill -S Date: 2024.12.12 17:53:26 -06'00' Alicia L. Hemphill Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Submission Number (if known) | K241253 Device Name Medicon Epiplating System | Indications for Use (Describe) | | |--------------------------------|--| |--------------------------------|--| The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye). Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) 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 0MB number." {4}------------------------------------------------ # 510(k) Summary | Submitter's Name and Address: | CMF MEDICON SURGICAL INC 11200 St. Johns Industrial Pkwy N. Suite 1 Jacksonville, FL 32246 USA | |-------------------------------|---------------------------------------------------------------------------------------------------------| | Official Contact: | Matthias Alber Executive Vice President | | Contact Person and Telephone: | Matthias Alber 904-642-7500 | | Date Summary Prepared: | 11/19/2024 | | Device Name: | Proprietary Name - Medicon Epiplating System | | Device Class: | Class II | | Classification: | 21 CFR § 878.3680 | | Product Code: | FZE | ## Predicate Device: Primary Predicate Device | Manufacturer | Device Name | K Number | Classification | |---------------------------------|--------------------------|----------|-------------------------------| | Southern Implants (Pty) Ltd. | Osseointegrated Fixtures | K161548 | Prosthesis, Nose, Internal | ## Reference Devices | Manufacturer | Device Name | K Number | Regulation number and product code | Classification | |---------------------------------|---------------------------------------------------------|----------|------------------------------------------|--------------------------| | MEDICON, E.G. | TITANIUM MINIPLATE SYSTEM | K951690 | 872.4760 JEY | Plate, Bone | | MEDICON, E.G. | CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM | K951691 | 872.4760 JEY | Plate, Bone | | HOWMEDICA LEIBINGER, INC. | Epitec™ Titanium Implant System | K961719 | 888.3030 HRS | Plate, Fixation, Bone | ## Device Description: The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136). {5}------------------------------------------------ ## Indication for Use: The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye). ## Technological Characteristics: The subject Medicon Epiplating System and the predicate devices are all used in the same way: they are fixated in bone where they are intended to osseointegrate to provide an attachment for a prosthesis. The material for all implants and the operating principle, which is permanent fixation by osseointeqration, are the same. | | Subject Device K241253 | Predicate Device K161548 | Reference Device K961719 | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name: | Medicon Epiplating System | Osseointegrated Fixtures | EPITEC TITANIUM IMPLANT SYSTEM | | Indications for use: | The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye). | Southern Implants Osseointegrated Fixtures is indicated for the attachment of an external aesthetic restoration prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo- craniofacial region (including ear, nose and eye). | The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples: Ear prostheses Orbital prostheses Nose prostheses Cheek prostheses Hair pieces Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring. | | User Interface | Manual insertion of the implants with specifically developed tools provided to the end-user. In addition, instructions for use are available. | Same | Same | | Operating Principle | Permanent fixation by osseointegration | Same | Same | | Physical (Design) | Plates and screws in many different shapes | Single implants with different lengths and diameters | Plates and screws in many different shapes | | Bone fixation points per implant | Multiple | Single | Multiple | | Materials | Titanium | Same | Same | | Sterility | Unsterile delivery | Sterile delivery | Unsterile Delivery | | Biocompati | ASTM F136-13 | Same | Same | | | Subject Device K241253 | Predicate Device K161548 | Reference Device K961719 | | bility | ASTM F67-13 ISO 5832-2 ISO 5832-3 | | | | Cleaning and Sterilization | Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013 Manual cleaning and machine cleaning in accordance with AAMI TIR30:2011 | Not applicable, items are delivered in sterile condition | Unknown | The subject and predicate devices are based on the following same technological elements: {6}------------------------------------------------ As was established in this submission, the subject Medicon Epiplating System is substantially equivalent to the other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent based on technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. ## Performance Data: The following performance data were provided in support of the substantial equivalence determination: ## Mechanical testing Bench testing of the Medicon Epiplating System was performed in accordance with ASTM F382. The following tests were performed with the worst-case implant: - proof of load. O - bending strength, O - O bending stiffness (=slope) - structural bending stiffness of the worst-case implant O A side-by-side comparison and detailed worst-case analysis of each of the subject devices to the reference device K961719 has been performed. K961719 has the same indications for use and a very similar design as this subject device. The results of this side-by-side comparison demonstrate substantial equivalence to the legally marketed predicate devices. ## Sterilization validation Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013. ## Cleaning Manual cleaning and machine cleaning validation in accordance with AAMI TIR30:2011. ## Biocompatibility Previously cleared devices with identical material and manufacturing methods have been tested according to ISO 10993-1. ## Conclusion: Based on the indication for use, technological characteristics, mechanical testing, and comparison to predicate devices, the subject Medicon Epiplating System demonstrates substantial equivalence to the legally marketed predicate devices.