PEDINAIL INTRAMEDULLARY NAILING SYSTEM

K083726 · OrthoPediatrics Corp. · HSB · Mar 11, 2009 · Orthopedic

Device Facts

• Record ID: K083726
• Device Name: PEDINAIL INTRAMEDULLARY NAILING SYSTEM
• Applicant: OrthoPediatrics Corp.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

Device Story

OrthoPediatrics PediNail is a rod-shaped intramedullary nail for femoral fracture fixation; device inserted into medullary canal; transverse screws installed through rod holes for additional stabilization; provides immediate stability and temporary fixation during natural bone healing; intended for single use; used by surgeons in clinical settings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Rod-shaped intramedullary nail; 316L stainless steel per ASTM-F138; includes transverse screw holes for fixation; single-use.

Indications for Use

Indicated for pediatric and small stature adult patients requiring stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, nonunions, malunions, osteotomy-corrected deformities, simple long bone fractures, comminuted/spiral/oblique/segmental fractures, polytrauma, reconstruction post-tumor resection, supracondylar fractures, and bone lengthening/shortening.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Tri-Gen Adolescent TAN (K040929)
• Adolescent Lateral Entry Nail (K070843)
• Intramedullary Nail System (stainless steel) (K983942)
• Titanium Pediatric Femoral Nail (K993956)
• Femoral Locking Nail System (K072161)
• Lateral Entry Femoral Nail System (K040336)

Submission Summary (Full Text)

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

K083726 #1/2

MAR 1 1 2009

# SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | OrthoPediatrics, Corp.<br>210 N. Buffalo Street<br>Warsaw, Indiana 46580<br>Establishment Registration No.: 9102640 |
|-----------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Gary Barnett<br>VP-Regulatory & Medical Affairs<br>Tel: [phone]<br>Fax: [phone] |
| TRADE NAME: | OrthoPediatrics PediNailTM Intramedullary Nailing<br>System |
| COMMON NAME: | Intramedullary nail |
| CLASSIFICATION: | 21 CFR 888.3020: Intramedullary fixation rod and<br>accessories: Class II per 21 CFR §888.3020 |

DEVICE PRODUCT CODE(S): HSB

#### SUBSTANTIALLY EQUIVALENT DEVICES:

K040929, Tri-Gen Adolescent TAN, Smith & Nephew

K070843, Adolescent Lateral Entry Nail, Synthes

K983942, Intramedullary Nail System (stainless steel), Smith & Nephew

K993956, Titanium Pediatric Femoral Nail, Biomet

K072161, Femoral Locking Nail System, Biomet

K040336, Lateral Entry Femoral Nail System, Synthes

## DEVICE DESCRIPTION:

OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel.

The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of

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

K083726 #2/2

impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

- Materials: The devices are manufactured from 316L stainless steel which . meets the ASTM-F138 standard.
- . Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

### INDICATIONS FOR USE:

The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail 116 is for single use only.

#### 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.

Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is black, and the text is also black.

MAR 1 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthopediatrics, Corp. % Mr. Gary Barnett VP, Regulatory & Medical Affairs 210 North Buffalo Street Warsaw, Indiana 46580

Re: K083726

Trade/Device Name: OrthoPediatrics PediNail™ Intramedullary Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 10, 2008 Received: December 15, 2008

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 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.

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

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,

Sana Ahmed. for.

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

Enclosure

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

## Indications for Use Statement

# 510(k) Number (if known): KO 83776

## Device Name: OrthoPediatrics PediNail ™ Intramedullary Nailing System

The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include simple long bone fractures; severely comminuted. spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
|----------------------------------------------|---|

AND/OR

| Over-The-Counter Use (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)

| | <i>S/m D.</i> |
|--|---------------|
|--|---------------|

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

| s10(k) Number | Page 1 |
|---------------|--------|
|---------------|--------|

7

品牌 【 】

1 of 1