EXTRIMILOCK ANKLE PLATING SYSTEM

K133691 · Osteomed LP · HRS · Feb 24, 2014 · Orthopedic

Device Facts

• Record ID: K133691
• Device Name: EXTRIMILOCK ANKLE PLATING SYSTEM
• Applicant: Osteomed LP
• Product Code: HRS · Orthopedic
• Decision Date: Feb 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only. The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device. The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.

Device Story

The OsteoMed ExtremiLOCK Ankle Plating System is a bone fixation system comprising plates, screws, and K-wires used by surgeons for fracture management, arthrodesis, and osteotomies. The system provides compression, non-locking, and locking hole designs to stabilize bony fractures of the distal tibia and fibula. Implants are provided in various shapes and sizes; surgical instrumentation is included to facilitate insertion, modification, and removal. The device is used in clinical settings (OR) to provide mechanical stabilization of bone segments, promoting healing and structural integrity. It is intended for single use only.

Clinical Evidence

Bench testing only. Verification evaluation included pull-out, torque, and bending tests to ensure mechanical strength. No clinical data was required to support substantial equivalence.

Technological Characteristics

Implants manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). Instrumentation made from stainless steel, anodized aluminum, and medical grade polymer. System features angulated locking screws, standard non-locking screws, and plates with compression, non-locking, and locking hole designs.

Indications for Use

Indicated for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula in adult and pediatric patients. Also indicated for trauma, general surgery, and reconstructive procedures of bones appropriate for device size.

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

• Synthes Dynamic Compression Locking Plating System (Synthes One-Third Tubular DCL Plate) (K011335)
• OsteoMed Foot Plating System (K091614)
• OsteoMed Super Screw 3.5mm (K954330)
• Merete Locking Bone Plate System III (K120787)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in bold, black letters. The word is inside of a black oval shape. There is a registered trademark symbol in the upper right corner of the oval.

K133691 (pg 1/3)

## 510(k) Summary

FEB 2 4 2014

Submitter Information:

OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Contact Person:

Blesson Abraham

Date Prepared: November 27, 2013

Device Information:

Proprietary/Trade Name: OSTEOMED Ankle Plating System Common Name: Bone Plating System

Classification Name:

- · Regulation Number: o 21 CFR 888.3030
- o 21 CFR 888.3040
- · Regulation Name:
- o Single/multiple component metallic bone fixation appliances and accessories (Plate, Fixation, Bone)
- o Smooth or threaded metallic bone fixation fastener (Screw, Fixation, Bone: Pin, Fixation, Smooth)
- · Product Code:
- HRS o
- HWC o

Device Class: II

#### Predicate Devices:

Synthes Dynamic Compression Locking Plating System (Synthes One-Third Tubular DCL Plate), K011335 Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS) Device Class: II

OsteoMed Foot Plating System, K091614 Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS) Device Class: II

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#### OsteoMed Super Screw 3.5mm, K954330

Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)

#### Device Class: Il

#### Merete Locking Bone Plate System III, K120787

Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS) Smooth or threaded metallic bone fixation fastener (21CFR 888.3040. Product Code HWC)

Device Class: II

#### Device Description:

The OSTEOMED ExtremiLOCK Ankle Plating System is a comprehensive ankle fracture system intended to provide solutions for various bony fractures, including simple to complex fractures of the distal tibia and fibula. The plates are provided in a variety of shapes and sizes, offering surgeons compression, non-locking and locking hole designs. The ExtremiLOCK Ankle Plating System includes angulated locking screws and standard non-locking screws as well as K-wires. Surgical instrumentation is provided to facilitate insertion, modification and/or removal of implants.

The implants of the OsteoMed ExtremiLOCK Ankle Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

#### Intended Use:

The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only.

The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.

#### Technological Characteristics:

The OsteoMed Extremil.OCK Ankle Plating System is recommended for fixation/reconstruction of distal tibia and fibula, or other bones appropriate for the size of the device.

ExtremiLOCK implants are manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), the same materials used in the manufacture of the predicate devices. These materials are biocompatible.

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#### Performance / Clinical Data:

The OsteoMed ExtremiLOCK Ankle Plating System was compared to the Synthes One-Third Tubular DCL Plate, K011335, the OsteoMed Foot Plating System, K091614, the OstedMed Super Screw 3.5mm, K954330, and the Merete Locking Bone Plate System III, K120787. The Extremil.OCK Ankle implants underwent verification evaluation (pull-out, torque and bending tests) to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsteoMed ExtremiLOCK Ankle implants is similar to the Synthes One-Third Tubular DCL Plate, the OsteoMed Foot Plating System, the OstedMed Super Screw 3.5mm, and the Merete Locking Bone Plate System III.

Performance equivalence was shown through the verification comparison to the predicate devices.

Clinical Testing is not required to support substantial equivalence.

#### Substantial Equivalence:

A design and dimensional comparison was performed to establish substantial equivalence to the legally marketed predicate devices listed in this summary. The basis of substantial equivalence for this device is based on similarities in intended use, function, performance, design, technology and operational principles to the Synthes One-Third Tubular DCL Plate (K011335), the OsteoMed Foot Plating System (K091614), the OsteoMed Super Screw 3.5mm (K954330), and similarities in intended use, material, and function to the Merete Locking Bone Plate System III (K120787).

Substantial equivalence was shown through the pullout test, and bending test to the predicate devices (the Synthes One-Third Tubular Plate, the OsteoMed Foot Plating System, and the OsteoMed Super Screw 3.5mm). The intended use, design, technology and operational principles are similar between the subject and predicates (the Synthes One-Third Tubular Plate, the OsteoMed Foot Plating System, the OsteoMed Super Screw 3.5mm, and Merete Locking Bone Plate System III), and therefore OsteoMed believes that the OSTEOMED ExtremiLOCK Ankle Plating System does not raise any new safety or effectiveness issues.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

#### Public Health Service

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

February 24, 2014

OsteoMed Mr. Blesson Abraham Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001

Re: K133691

Trade/Device Name: OsteoMed ExtremiLOCK Ankle 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 Dated: November 27, 2013 Received: December 2, 2013

Dear Mr. Abraham:

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. 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.

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

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#### Page 2 - Mr. Blesson Abraham

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Vincent訂房@evlin -S

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: OsteoMed ExtremiLOCK Ankle Plating System

Indications for Use:

The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only.

The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth南®rank -S

Division of Orthopedic Devices