ORTHO SOLUTIONS ULTOS PLATING SYSTEM

K141784 · Ortho Solutions Limited · HRS · Jul 23, 2014 · Orthopedic

Device Facts

• Record ID: K141784
• Device Name: ORTHO SOLUTIONS ULTOS PLATING SYSTEM
• Applicant: Ortho Solutions Limited
• Product Code: HRS · Orthopedic
• Decision Date: Jul 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions UltOS Plating System is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton. This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible. The Ortho Solutions UltOS Plating System is not intended for spinal use.

Device Story

The UltOS Plating System is a metallic bone fixation set for foot, ankle, and toe surgery. It comprises 12 plate types (e.g., arthrodesis, fusion, opening wedge, calcaneal step) and 2.7mm/3.5mm locking/non-locking screws. Surgeons use the system in a clinical setting to draw aligned bone fragments together to facilitate healing. The device is purely mechanical; it does not involve sensors, algorithms, or software. It is provided sterile or non-sterile for single-use. The system includes associated manual instrumentation such as pliers, drills, K-wires, and screwdrivers. Clinical benefit is derived from the stabilization of bone fragments during the healing process.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Metallic bone fixation system manufactured from Alloyed Titanium (Ti-6Al-4V) per ASTM F136. Includes plates and screws (2.7mm/3.5mm diameter). Manual instrumentation includes compression/distraction pliers, drills, and screwdrivers. No software, electronics, or energy sources. Sterilization provided for both sterile and non-sterile configurations.

Indications for Use

Indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones in the feet, ankles, and toes. Not for spinal use.

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

• Ortho Solutions - FPS System (K111678)
• Wright Medical- DARCO MFS & MRS Systems (K061808, K100359)
• Synthes - Variable Angle ICP Forefoot/Midfoot System (K100776)

Submission Summary (Full Text)

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Ortho Solutions, Limited - 510(k) Summary:

### 510(k) Summary of Safety and Effectiveness

### JUL 2 3 2014

### SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary

| NAME OF FIRM: | Ortho Solutions Limited<br>West Station Business Park<br>Spital Road<br>Maldon<br>ESSEX, CM9 6FF<br>United Kingdom<br>www.orthosolutions.com |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott<br>Engineering Consulting Services, Inc.<br>3150 E. 200th St.<br>Prior Lake, MN 55372<br>Tel. No. 952-492-5858<br>e-mail: [e-mail] |
| DATE: | June 20, 2014 |
| TRADE NAME: | Ortho Solutions – UltOS Plating System |
| COMMON NAME: | Foot Bone Plate System |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener<br>(per 21CFR888.3040) – Screw, Fixation, Bone |

Single/multiple component metallic bone fixation appliance and accessories (per 21CFR888.3030) - Plate, Fixation, Bone

| DEVICE PRODUCT CODE: | HRS | |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| SUBSEQUENT PRODUCT CODE: | HWC, KTT | |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES | Ortho Solutions - FPS System (K111678)<br>Wright Medical- DARCO MFS & MRS Systems (K061808, K100359)<br>Synthes - Variable Angle ICP Forefoot/Midfoot System (K100776) | |

The Ortho Solutions UltOS Plating System is designed to address a DEVICE DESCRIPTION: variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of Twelve(12) Plate Types that accept both a smaller 2.7mm and larger 3.5mm Locking/ Non-locking Screw ( in various lengths of 8mm thru 50mm) with all screw heads of uniform size to fit any plate type. The UltOS System 'Twelve(12) Plate Types' consist of the following:

Ortho Solutions UltOS Plating System

Page 1 of 3 Section XII

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Ortho Solutions, Limited - 510(k) Summary: DEVICE DESCRIPTION CONTINUED:

1). A Arthrodesis Wedge Plate (AWP) in 5 sizes of 0, 2, 4, 6 & 8mm. plate wedge widths,

2). A General Fusion Straight Plate (GFS) in 2 sizes of a 2 & 4 screw hole plate.

3). A General Fusion "T" Plate (GFT) in 3 sizes of a 2, 4 & 6 screw hole plate.

4). A Metatarsophalangeal Plate (MTP) in 3 sizes, Left & Right, of a Small, Medium & Large plate size,

5). A Opening Wedge Locking Plate (OWL) in 6 sizes of 0, 3, 4, 5, 6 & 7mm plate wedge widths,

6). A Opening Wedge Plate (OWP) in 6 sizes of a 0, 2.5, 3, 4, 5 & 7mm plate wedge widths.

7). A Calcaneal Step Plate (CSP) in 3 sizes of 8, 10 & 12mm plate step heights.

8). A General Fusion "X" Plate (GFX) in 4 sizes of a Extra Small, Small. Medium & Large plate size,

9). A Lapidus Plate (LAP) in 4 sizes, Left & Right, of a 0, 2, 4 & 6mm plate offset heights,

10). A Rearfoot Reconstruction Plate (RRP) in 3 sizes of a 6, 8 & 14 screw hole plate.

11). A Tarsal Fusion Plate (TFP) in 3 sizes of a 12, 14 & 16mm plate length, and

12). A Universal Locking Plate (ULP) in 5 sizes of a 12, 16, 20, 24 & 30mm plate length.

Screw diameters of 2.7mm and 3.5mm with either Locking or Non-Locking features and Cannulated 3.5mm self tapping screws in various lengths are also included in the UltOS Plating System.

Associated instrumentation such as compression and distraction pliers, disposable drills & wires/guide wires, drill guides, T8 torx screwdrivers and ancillary instrumentation is available. All plates and screws are manufactured from Alloyed Titanium Ti-6Al-4V to ASTM F136. All plates, screws, drills and K-wires are offered both 'Sterile' and 'Non-Sterile' to the customer.

#### INTENDED USE:

The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.

The Ortho Solutions UltOS Plating System is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.

This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.

The Ortho Solutions UltOS Plating System is not intended for spinal use.

Ortho Solutions UltOS Plating System

Page 2 of 3 Section XII

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Ortho Solutions, Limited - 510(k) Summary:

The Ortho Solutions UltOS Plating System is substantially equivalent EQUIVALENCE: to predicate systems from many orthopedic companies (as listed). No nonclinical testing was used in the determination of substantial equivalence.

The Ortho Solutions UltOS Plating System is similar in Material, SUMMARY OF TECH-Geometry Design/Markings, and Indications to many predicate systems NOLOGICAL CHAR-ACTERISTICS currently sold in the U.S. market.

SUMMARY OF SAFETY AND EFFECTIVENESS:

The Ortho Solutions UltOS Plating System is shown to be safe and effective as 'sterile' and 'non-sterile' for single-use in a surgical setting.

Ortho Solutions UltOS Plating System

Page 3 of 3 Section XII

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Unmoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 23, 2014

Ortho Solutions, Limited % Mr. Al Lippincott Engineering Consulting Scrvices. Inc. U.S. Agent and Official Correspondent to Ortho Solutions, Limited 3150 E. 200m St. Prior Lake, Minnesota 55372

Re: K141784

Trade/Device Name: Ortho Solutions UltOS Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC, KTT Dated: June 20, 2014 Received: July 2, 2014

Dear Mr. Lippincott:

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 10 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. Iabeling, and prohibitions against misbranding and adulteration. Please note: CDRII 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 requirements. including, but not limited to: registration and listing

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Page 2 -Mr. Al Lippincott

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

## Lori A. Wiqqins

- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K141784 510(k) NUMBER:

DEVICE NAME: Ortho Solutions UltOS Plating System

INDICATIONS FOR USE:

The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing.

The Ortho Solutions UltOS Plating System is Indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton.

This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible.

The Ortho Solutions UltOS Plating System is not intended for spinal use.

Over-The-Counter-Use Prescription Use _xx______xx_____xx_____xxx____xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx AND/OR (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D) (Please Do Not WRITE BELOW THIS LINE -- Continue on ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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