ACUMED PELVIC BONE PLATE SYSTEM

K122538 · Acumed, LLC · HRS · Nov 19, 2012 · Orthopedic

Device Facts

• Record ID: K122538
• Device Name: ACUMED PELVIC BONE PLATE SYSTEM
• Applicant: Acumed, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Nov 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

Device Story

Acumed Pelvic Bone Plate System provides internal bone fixation for pelvic injuries. System comprises titanium plates (ASTM F67) and titanium alloy screws (ASTM F136) in various sizes. Plates are contoured or trimmed intraoperatively by surgeons to match patient anatomy and injury patterns. Used in clinical settings by orthopedic surgeons to stabilize fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and pelvic ring, and to treat sacroiliac joint dislocations and symphysis pubis disruptions. Fixation is achieved via non-locking screw insertion. Implants are provided sterile or non-sterile for use with general surgical instrumentation. Device stabilizes bone segments to facilitate healing.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F382 (metallic bone plates) and ASTM F543 (metallic medical bone screws).

Technological Characteristics

Plates: Titanium (ASTM F67), 30-250mm length, 4-17mm width, 1.5-4mm thickness. Screws: Titanium alloy (ASTM F136), 2.7mm, 3.5mm, 4.3mm diameters. Fixation: Non-locking screw system. Sterilization: Provided sterile and non-sterile.

Indications for Use

Indicated for patients requiring bone fixation for fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, or treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

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

• Stryker Trauma Pelvic Set (K001614)
• I.T.S. Pelvic Reconstruction System (K063166)

Submission Summary (Full Text)

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# 510(k) Summary

## Contact Details

Applicant Name: Acumed LLC 5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432

> Kara Budor, Regulatory Specialist 503-207-1412

Date Prepared: August 20, 2012

### Device Name

Trade Name: Acumed Pelvic Bone Plate System

Common Name: Pelvic System

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

Class: II

Product Code: HRS

### Legally Marketed Predicate Device(s)

There are two predicate devices. The comparison is to the Stryker Trauma Pelvic Set and the I.T.S. Pelvic Reconstruction System.

| 510(k) Number | Product Code | Trade Name | Applicant |
|---------------|-----------------|----------------------------------------|--------------------------------------------------|
| K001614 | KTW<br>888.3030 | Stryker Trauma Pelvic Set | Howmedica Osteonics<br>Corp. |
| K063166 | HRS<br>888.3030 | I.T.S. Pelvic Reconstruction<br>System | I.T.S. Implantat-<br>Technologie-Systeme<br>GmbH |

# Device Description

The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium,

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and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

Plates are available in a variety of shapes and sizes which can be used "as is" or additionally contoured and/or trimmed intraoperatively to accommodate varying injury patterns and/or patient anatomy. All plates are made of titanium per ASTM F67 and are designed to accommodate the 3.5mm screws included in the system. Plates range in length from 30mm to 250mm, have a width of 4mm to 17mm, and a thickness of 1.5mm to 4mm.

The system includes 3 families of screws with different diameters: 2.7mm, 3.5mm, and 4.3mm. All screw families can be used for fixation independent of the plates. Screws are made of titanium alloy per ASTM F136.

All implants are provided sterile and non-sterile.

## Intended Use/Indications for use

The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

#### Substantial Equivalence Comparison

The basic comparison between the Acumed Pelvic Bone Plate System and the predicate devices is given in the table below.

| Category | Acumed Pelvic<br>Bone Plate System | I.T.S. Pelvic Reconstruc-<br>tion System K063166 | Stryker Trauma Pelvic Set<br>K001614 |
|------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Material | Titanium per ASTM F67<br>and Titanium alloy per<br>ASTM F136 | Commercially pure<br>titanium and 6-4 alloyed<br>titanium | Stainless Steel per ASTM<br>F138 |
| Plate Shape | Straight plates<br>Curved plates<br>Plates for anatomy specific<br>sites | Straight plates<br>Curved plates<br>Plates for anatomy specific<br>sites | Straight plates<br>Curved plates<br>Plates for anatomy specific<br>sites |
| Plate Fixation<br>Method | Screw fixation | Screw fixation | Screw fixation |
| Screw Type | Non-locking | Non-locking and Locking | Non-locking |
| Provided sterile<br>and/or non-<br>sterile | Provided sterile and non-<br>sterile | Unknown | Provided sterile and non-<br>sterile |
| Implants are<br>used with<br>general surgical<br>instrumentation | Yes | Yes | Yes |

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Acumed Pelvic Bone Plate System 510(k) Notification

The Acumed Pelvic Bone Plate System, the I.T.S. PRS Low Profile – Multiple Type – Pelvic Plating System, and the Stryker Trauma Pelvic Set are all systems of plates, screws, and instruments which are used to achieve fixation. There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Pelvic Bone Plate System is substantially equivalent to the predicate devices.

# Non-clinical Testing

The non-clinical testing included in this submission includes testing to ASTM F382 and F543.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### Letter Dated: November 19, 2012

Acumed, LLC % Ms. Kara Budor Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124

Re: K122538

Trade/Device Name: Acumed Pelvic Bone Plate 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: August 20, 2012 Received: August 21, 2012

Dear Ms. Budor: .

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- Ms. Kara Budor

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 (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.htmfor 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 vours. Erin I. Keith

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

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Acumed Pelvic Bone Plate System 510(k) Notification

# Indications for Use

510(k) Number (if known): K122538

Device Name: Acumed Pelvic Bone Plate System

Indications for Use:

The Acumed Pelvic Bone Plate System includes plates, screws, and accessories designed to provide fixation during fractures, fusions, and osteotomies for the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.

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) .

K. Ath

(Division Sign-Off) Division of Orthopedic Device 510(k) Number K12253

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