OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM

K131445 · Osteomed LP · HRS · Jun 18, 2013 · Orthopedic

Device Facts

• Record ID: K131445
• Device Name: OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
• Applicant: Osteomed LP
• Product Code: HRS · Orthopedic
• Decision Date: Jun 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device. The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

Device Story

System consists of metallic plates, screws (locking, non-locking, cannulated), K-wires, and washers; used for rigid fixation of bone fractures or reconstructive procedures. Implants manufactured from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). Instrumentation includes stainless steel, anodized aluminum, and medical-grade polymers. Used by surgeons in clinical settings to stabilize bone fragments. Provides mechanical support to facilitate bone healing. No software or electronic components.

Clinical Evidence

Bench testing only. Verification evaluation performed to ensure design features met mechanical strength criteria. No clinical data required for substantial equivalence.

Technological Characteristics

Metallic bone fixation system. Materials: Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). Instrumentation: stainless steel, anodized aluminum, medical-grade polymer. Mechanical fixation via plates and screws. No software, electronics, or connectivity.

Indications for Use

Indicated for trauma, general surgery, and reconstructive procedures of the foot, ankle, or other bones appropriate for device size. Intended for single use only.

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

• OsteoMed Foot Plating System (K091614)
• OsteoMed Calcaneal Plate and Screw Fixation (K071105)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in a stylized font. The word is in all caps and appears to be in bold. The word is surrounded by a black oval shape. The oval shape is thicker on the top and bottom, and thinner on the sides.

## K131445 Page 1 of 2

:

#### Special 510(k) Summary

JUN 1 8 2013

Name of Submitter: OsteoMed

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

Contact Person:

Blesson Abraham

Date Prepared:

May 17, 2013

Device Proprietary Name:

OsteoMed ExtremiLOCK Foot Plate and Screw Rigid Fixation System

21 CFR 888.3030: Single/multiple component metallic bone

OsteoMed Extremil.OCK Foot Plating System

Device Common Name:

Classification Name:

Product Code:

HRS

Predicate Devices:

OsteoMed Foot Plating System, K091614

Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS)

fixation appliances and accessories

Device Class: II

#### OsteoMed Calcaneal Plate and Screw Fixation, K071105

Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS)

Device Class: II

Summary:

#### Device Description:

The OsteoMed ExtremiLOCK Foot Plating System consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.

The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), Surgical instrumentation is provided to facilitate

OsteoMed 3885 Arapalio Road Addison, Texas 75001 [phone] FAX: [phone] Customer Service: [phone]

Image /page/0/Picture/29 description: The image shows the text "A COLSON ASSOCIATE". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a logo or heading, possibly indicating a company or organization name.

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

modification, insertion, and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.

#### Intended Use:

The OsteoMed Extremil.OCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

#### Technological Characteristics:

The OsteoMed ExtremiLOCK Foot Plating System is recommended for fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle 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.

#### Performance/Clinical Data:

The OsteoMed ExtremiLOCK Foot Plating System was compared to the OsteoMed Foot Plating System, K091614, and the OsteoMed Calcaneal Foot and Screw Fixation System, K071105. The ExtremiLOCK implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsteoMed ExtremiLOCK implants is the same as the OsteoMed Foot Plaing System and the OsteoMed Calcaneal Foot and Screw Fixation System.

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, dimensional. and performance 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, material, function, performance, design, technology and operational principles to the OsteoMed Foot Plating System (K091614), and similarities in material, function, design, technology and operational principles to the OsteoMed Calcaneal Plate and Screw Fixation (K071105).

The basis of substantial equivalence of the OsteoMed ExtremiLOCK Foot Plating System to the OsteoMed Foot Plating System. K091614, and the OsteoMed Calcaneal Foot and Screw Fixation System, K071105, is based on the similarities in design, technology, material, function, sterilization, and intended use. OsteoMed believes that the non-clinical tests demonstrate that the device is as safe, and effective as the predicate devices.

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

Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a human figure or a symbol representing health and well-being.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 18, 2013

OsteoMed % Mr. Blesson Abraham 3885 Arapaho Road Addison, Texas 75001

Re: K131445

Trade/Device Name: OsteoMed ExtremiLOCK Foot 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 Dated: May 17, 2013 Received: May 20, 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. Iisting 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 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

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

#### Page 2 – Mr. Blesson Abraham

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.

### Erin DKeith For

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

Enclosure

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

## Indications for Use

510(k) Number (if known): K131445

Device Name: OsteoMed ExtremiLOCK Foot Plating System

Indications for Use:

The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.

The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.

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)

# Elizabet荷物排rank -S

Division of Orthopedic Devices