ORTHOPEDIATRICS PLATING SYSTEM

K073344 · Orthopediatrics, LLC · HRS · Feb 19, 2008 · Orthopedic

Device Facts

• Record ID: K073344
• Device Name: ORTHOPEDIATRICS PLATING SYSTEM
• Applicant: Orthopediatrics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Feb 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.

Device Story

OrthoPediatrics Plating System consists of bone plates and screws designed for internal fixation of pelvic, small, and long bone fractures, osteotomies, mal-unions, and mal-alignments. The system provides immediate stability and temporary fixation during the bone healing process. Plates are available in three distinct shapes (H, I, and infinity symbol) in multiple sizes to accommodate patient anatomy. The device is used by orthopedic surgeons in a clinical or surgical setting. The surgeon selects and implants the appropriate plate and screw configuration to achieve optimal bone fixation, facilitating patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from 316L stainless steel conforming to ASTM F138, ASTM F139, and ISO-5832 standards. System includes cortical and cannulated screws and specialty plates in H, I, and infinity shapes. Mechanical fixation device; no software or electronic components.

Indications for Use

Indicated for the treatment of pelvic, small and long bone fractures in pediatric and general orthopedic patients.

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

• Precimed Trauma System (K002486)
• Precimed Cannulated Screw System (K050754)
• Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) (K993106)

Submission Summary (Full Text)

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

K073344 (pg. 1 of 2)

# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | OrthoPediatrics, Corp.<br>210 N. Buffalo Street<br>Warsaw, Indiana 46580<br>Establishment Registration No.: 9102640 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | FEB 19 2003 |
| 510(K) CONTACT: | Gary Barnett<br>VP-Regulatory & Quality<br>Tel: [phone]<br>Fax: [phone] |
| TRADE NAME: | OrthoPediatrics Plating System |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | Single/multiple component metallic bone fixation<br>appliances and accessories: Class II per 21 CFR<br>§888.3030 |
| DEVICE PRODUCT CODE(S): | HRS and HWC |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Precimed Trauma System (K002486)<br>Precimed Cannulated Screw System (K050754)<br>Smith & Nephew Bone Plate System (TC-100<br>Plating and Screw System) (K993106) |

### DEVICE DESCRIPTION:

The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric and general orthopedic surgeon with necessary devices to achieve optimal bone fixation when treating fractures, osteotomies, mal-unions, and mal-alignments.

- Materials: The devices are manufactured from 316L stainless steel, which . meet ASTM F138 and F139, and ISO-5832 standards.
- Eunction: The system functions to provide immediate stability and . temporary fixation during the natural healing process.

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

K073344 (pg. 2 of 2)

The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures. The system includes cortical and cannulated screws, and specialty plates. The specialty plates will include three distinct shapes and each shape will be offered in multiple sizes to accommodate the individual requirements of the patient anatomy to aid the surgeon in achieving optimal fixation. The three specialty plates' shapes resemble the letters H and I, and the infinity symbol (similar to the number 8, lying on its side).

#### INDICATIONS FOR USE:

The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.

## BASIS FOR SUBSTANTIAL EQUIVALENCE:

OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications. Indications include fixation for pelvic, small and long bone fractures.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is depicted in black and white.

Public Health Service

FEB 19 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OrthoPediatrics, Corporation % Mr. Gary Barnett Vice President, Regulatory & Quality 210 N. Buffalo Street Warsaw, Indiana 46580

Re: K073344 Trade/Device Name: OrthoPediatrics 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 19, 2007 Received: November 28, 2007

Dear Mr. Barnett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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

Page 2 - Mr. Gary Barnett

CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): K073344

#### Device Name: OrthoPediatrics Plating System

The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.

Prescription Use × Over-The-Counter Use Preschption Ose
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Mulhern

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K07 33 44