OSTEOMED WRIST PLATING SYSTEM

K120015 · Osteomed LP · HRS · Apr 24, 2012 · Orthopedic

Device Facts

• Record ID: K120015
• Device Name: OSTEOMED WRIST PLATING SYSTEM
• Applicant: Osteomed LP
• Product Code: HRS · Orthopedic
• Decision Date: Apr 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures. OsteoMed Wrist Plating System implants are intended for single use only.

Device Story

Rigid bone fixation and fusion system; consists of anatomically pre-contoured plates and variable angle locking or non-locking screws (solid or cannulated). Used by surgeons in trauma, general surgery, and reconstructive procedures to stabilize bone fractures or facilitate fusion. Implants are single-use. System includes instrumentation for implantation and removal. Clinical benefit derived from mechanical stabilization of bone segments to promote healing.

Clinical Evidence

Bench testing only; mechanical strength analyses of plate and screw components were conducted to demonstrate equivalence to predicate devices.

Technological Characteristics

Titanium alloy (ASTM F136) plates and screws; K-wires of titanium alloy (ASTM F136) or stainless steel (ASTM F138). Instrumentation composed of stainless steel, anodized aluminum, and medical grade polymers. System features variable angle locking/non-locking mechanisms and cannulated/solid screw options.

Indications for Use

Indicated for fracture fixation, fusion, and osteotomies of the wrist and other bones appropriate for device size; intended for trauma, general surgery, and reconstructive procedures.

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 Hand Plating System (K090522)
• OsteoMed Foot Plating System (K091614)
• M3 Lag Screw Fixation System (K924018)
• Stryker Leibinger Universal Distal Radius System (K040022)
• PERI-LOC Periarticular Locked Plating System (K051735)
• Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate (K083694)
• Synthes (USA) 2.4mm LCP Volar Column Distal Radius Plates (K091644)
• Synthes (USA) LCP Wrist Fusion Plates (K042355)
• Dorsal Nail Plate, Anatomical (K052248)
• OsteoMed Extended 2.0/2.4 Cannulated Screw System (K062863)

Submission Summary (Full Text)

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K120015#1/d

## 510(k) Summary

Date Prepared:

Name of Submitter:

April 18, 2012

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

Contact Person:

Suzanne Cheang

Device Proprietary Name:

Common Name:

Wrist Plating System

OsteoMed Wrist Plating System

Classification Name:

21 CFR § 888.3030: Single/multiple component metallic bone fixation appliances and accessories

Product Code:

HRS, HWC

### Device Description:

The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates,

#### Indication for Use:

OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist Plating System implants are intended for single use only.

### Substantial Equivalence:

K090522: OsteoMed Hand Plating System K091614: OsteoMed Foot Plating System K924018: M3 Lag Screw Fixation System

APR 2 4 2012

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K120015#2/2

K040022: Stryker Leibinger Universal Distal Radius System K051735: PERI-LOC Periarticular Locked Plating System K083694: Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate K091644: Synthes (USA) 2.4mm LCP Volar Column Distal Radius Plates K042355: Synthes (USA) LCP Wrist Fusion Plates K052248: Dorsal Nail Plate, Anatomical K062863: OsteoMed Extended 2.0/2.4 Cannulated Screw System

Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers. There are no technological characteristics that raise new issues of safety or effectiveness.

Analyses of plate and screw strength were conducted to compare the OsteoMed Wrist Plating system components to predicate devices.

Equivalence for OsteoMed Wrist Plating system is based on similarities in intended use, design and operational principle to the referenced predicates. Based on the similarities, we believe that the OsteoMed Wrist Plating System does not raise any new safety or effectiveness issues.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three human figures.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OsteoMed % Ms. Suzanne Cheang Regulatory Affairs Specialist 3885 Arapaho Road Addison, Texas 75001

Re: K120015

Trade/Device Name: OsteoMed Wrist 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: March 1, 2012 Received: March 2, 2012

Dear Ms. Cheang:

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 or any Federal statutes and regulations administered by other Federal agencies. You must

APR 2 4 2012

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Page 2 - Ms. Suzanne Cheang

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Fir Doth

Mark N. Melkerson // st o Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _K120005

Device Name: OsteoMed Wrist Plating System

Indications for Use:

OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.

OsteoMed Wrist 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)

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Device ذ

510(k) Number K120215

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