MIOT PLATING SYSTEM

K051945 · Orthofix Srl · HRS · Sep 6, 2005 · Orthopedic

Device Facts

• Record ID: K051945
• Device Name: MIOT PLATING SYSTEM
• Applicant: Orthofix Srl
• Product Code: HRS · Orthopedic
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Orthofix MIOT Plating System is intended for non-load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures and reconstruction.

Device Story

The Orthofix MIOT Plating System is a bone fixation device consisting of stainless steel plates designed for small bone fragments. The system features various shapes (straight, C, L, and oblique) and sizes, which are precontoured but can be bent to fit specific anatomical requirements. The plates are attached to bone using stainless steel wires. The device is used by surgeons in clinical settings to stabilize small bone fragments during fresh fracture repair, revision surgeries, or reconstructive procedures. By providing non-load-bearing fixation, the system supports bone healing and structural alignment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons.

Technological Characteristics

Materials: Stainless steel. Form factor: Small bone plates in various shapes (straight, C, L, oblique) and sizes. Principle: Mechanical fixation using plates and stainless steel wires. Non-load-bearing.

Indications for Use

Indicated for non-load-bearing stabilization and fixation of small bone fragments in patients requiring treatment for fresh fractures, revision procedures, or reconstruction.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Smith & Nephew TC-100 mini-plate system

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness

# Orthofix MIOT Plating System

510(k) number K051945

- 1. General Information:

| Proprietary Name | Orthofix MIOT Plating System |
|--------------------------|------------------------------------------------------------------------------------|
| Common Name | Bone Plate |
| Regulatory Class | II |
| Device Classification | 87HRS (21 CFR 888.3030) |
| Submitter | R. Sheridan Consulting, LLC<br>632 Dundee Drive<br>Wilmington<br>N.C. 28405<br>USA |
| Registration number | 9680825 |
| Contact Person | Rolando Stanghellini<br>Via delle Nazioni 9<br>37012 Bussolengo (VR)<br>Italy |
| Summary Preparation Date | July 2005 |

## 2. Description

The Orthofix MIOT plating system consists of bone plates made of stainless steel The Oftholix MIOT plaining cyclom small bone fragments. They are anatomically designed for the internamized fragment adapted approach. If necessary, they precontoured and allow a casternization in the sare available in different shapes Can be bent to doquire the doch on a left and a right configuration and come in (Straight, C =, 1 - and oblique - onaps), in a levening stainless steel FFS wires. Plates umerent sizes. They are attached to FFS wires, depending upon its shape and size. can accommodule throughts for the insertion and removal of the plates.

67
\$\rho^{1/2}\$

{1}------------------------------------------------

### 3. Intended Use

The Orthofix MIOT Plating System is intended for non-load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures and reconstruction.

#### 4. Substantial equivalence

Documentation is provided which demonstrated the Orthofix MIOT Plating System to be substantially equivalent to other legally marketed devices.

Both the Orthofix MIOT Plating System and the predicate Smith & Nephew TC-100 mini-plate system are bone fixation systems as defined in 21 CFR 888.3030. These implantable devices consist of a small shaped bone plates held in place to stabilize and fix small bone fragments. The size, shape, and materials for the Orthofix MIOT Plating System are comparable to the predicate

#### 5. Conclusion

Based upon the similarities in design, materials and intended uses of the Orthofix MIOT Plating System is substantially equivalent to the predicate devices.

68

K051945-P²/2

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP -6 2005

Orthofix SRL c/o Ms. Candace F. Cederman R. Sheridan Consulting, LLC 632 Dundee Drive Wilmington, North Carolina 28405

Re: K051945

Trade/Device Name: Orthofix MIOT Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 12, 2005 Received: July 18, 2005

Dear Ms. Cederman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Candace F. Cederman

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter with and by of substantial equivalence of your device of your device to a legally premaince notification. The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please it you attime office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

signature

ه Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure 1

{4}------------------------------------------------

#### INDICATIONS FOR USE

| 510(k) Number (if known): | K051945 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Orthofix MIOT Plating System |
| Indications for Use: | The Orthofix MIOT Plating System is intended for non-<br>load-bearing stabilization and fixation of small bone<br>fragments in fresh fractures, revision procedures and<br>reconstruction. |

× Prescription Use: _ (Part 21 CFR 801 Subpart D) Or

Over-The-Counter_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K051945

Page 1 of 1