Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a mechanical implant system and its performance testing, with no mention of AI or ML technologies.

Therapeutic

No
The device is used for prosthetic attachment to restore a physical defect, rather than to treat or cure a disease or medical condition.

Diagnostic

No

The device is described as an implant system for attaching external restoration prostheses, providing bone anchorage. Its intended use is to restore physical defects, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "implant system consisting of various plates" manufactured from titanium, indicating it is a hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the attachment of an external restoration prosthesis to a physical defect using bone anchorage. This is a surgical implant used for structural support and attachment, not for analyzing biological samples to diagnose or monitor a condition.
Device Description: The device is described as an implant system consisting of plates and components made of titanium. This aligns with a surgical implant, not a device used for in vitro testing.
Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), reagents, or for the purpose of obtaining diagnostic information from these samples.

Therefore, the Medicon Epiplating System falls under the category of a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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).

Product codes (comma separated list FDA assigned to the subject device)

FZE

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillo-craniofacial region (including ear, nose and eye)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161548

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K951690, K951691, K961719

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.3680 Nose prosthesis.

(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.

Summary

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.