PEDILOC FRAGMENT SYSTEM

K140431 · OrthoPediatrics Corp. · HRS · Jul 29, 2014 · Orthopedic

Device Facts

• Record ID: K140431
• Device Name: PEDILOC FRAGMENT SYSTEM
• Applicant: OrthoPediatrics Corp.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

Device Story

PediLoc Fragment System comprises metallic bone plates and screws for temporary internal fixation and stabilization of fractures, osteotomies, mal-unions, and non-unions. System utilizes conventional plating technology and fixation techniques to provide immediate bone stability during healing. Intended for use in pediatric subgroups (excluding neonates) and small stature adults. Operated by orthopedic surgeons in clinical/surgical settings. Output is physical stabilization of bone segments; healthcare providers use visual/radiographic confirmation to assess alignment and healing. Benefits include restoration of skeletal stability and support for bone union.

Clinical Evidence

Bench testing only. Mechanical laboratory testing included static and dynamic testing, FEA analysis, and dimensional comparison against predicate devices. No clinical data provided.

Technological Characteristics

Materials: Medical grade stainless steel and cobalt-chromium-molybdenum. Design: Metallic bone fixation plates and screws. Testing performed per ASTM standards. No software or electronic components.

Indications for Use

Indicated for temporary internal fixation and stabilization of long bones, small bones, pelvis, and scapula in pediatric patients (excluding neonates) and small stature adults. Applicable for fractures, osteotomies, mal-unions, and non-unions.

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

• OrthoPediatrics Fracture and Osteotomy Bone Plate System (K111086)
• OrthoPediatrics PediLoc Locking Plate System (K083286)
• OrthoPediatrics Bone Screws (K082949)
• Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)

Submission Summary (Full Text)

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## 510(k) Summary

# JUL 2 9 2014

.

| NAME OF FIRM: | OrthoPediatrics, Corp.<br>2850 Frontier Drive<br>Warsaw, IN 46582 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 16, 2014 |
| 510(K) CONTACT: | Mark Fox<br>Vice President, Regulatory Affairs<br>Tel: [phone] |
| PROPOSED TRADE<br>NAME: | PediLoc Fragment System |
| DEVICE<br>CLASSIFICATION: | Class II; 21 CFR 888.3030 and 21 CFR 888.3040 |
| CLASSIFICATION<br>NAME: | Sinqle/multiple component metallic bone fixation appliances<br>and accessories. Smooth or threaded metallic bone fixation<br>fastener. |
| PRODUCT CODE: | KTT, HRS, HWC, HTN |
| DEVICE<br>DESCRIPTION: | The OrthoPediatrics' PediLoc Fragment System<br>combines implants and instruments in one convenient<br>and comprehensive system. This System provides<br>immediate stability and temporary fixation of bones<br>during the healing process with conventional plating<br>technology and fixation techniques. |
| INDICATIONS FOR<br>USE: | OrthoPediatrics' PediLoc Fragment System is intended<br>to provide temporary internal fixation and stabilization of<br>long bones, short (small) bones, pelvis, and scapula.<br>This includes fractures, osteotomies, mal-unions, and<br>non-unions in all pediatric subgroups (except neonates),<br>and small stature adults. |
| MATERIALS: | Medical grade Stainless Steel<br>Medical grade cobalt-chromium-molybdenum |
| PREDICATE DEVICES: | OrthoPediatrics Fracture and Osteotomy Bone Plate System<br>(K111086)<br>OrthoPediatrics PediLoc Locking Plate System (K083286)<br>OrthoPediatrics Bone Screws (K082949)<br>Synthes Small Fragment Dynamic Compression Locking<br>(DCL) System (K000684) |

:

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TECHNOLOGIC CHARACTERISTICS:

PERFORMANCE DATA:

NONCLINICAL TESTING:

The fundamental scientific principles and technological characteristics, including the intended use, material, and general design, and sizes of the device are the same as, or similar to, the predicate devices.

Tests performed according to ASTM Standards, demonstrated that the device performs as well as or better than the predicate devices.

Nonclinical testing included mechanical laboratory (bench) testing. Static and dynamic testing in addition to FEA analysis and comparisons of the subject devices with legally marketed predicates identified within this submission were performed. Dimensional comparison review and analysis with engineering rational provided additional nonclinical supportive data. The subject devices performed as well as or better than the predicate devices.

#### CONCLUSION:

The OrthoPediatrics' PediLoc Fragment System has the same intended use and technological characteristics as the predicate devices. Therefore the OrthoPediatrics' PediLoc Fragment System is substantially equivalent for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES/USA" is arranged in a circular fashion around the bird-like figure.

#### 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

July 29, 2014

OrthoPediatrics Corporation Mr. Mark Fox V. P. Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

Re: K140431

Trade/Device Name: PediLoc Fragment 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, HTN, KTT Dated: June 16, 2014 Received: June 17, 2014

Dear Mr. Fox:

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 gencral 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 comply with all the Act's requirements, including, but not limited to: registration and listing

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Page 2 - Mr. Mark Fox

(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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Lori A. Wiggins

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

Enclosure

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K140431 - page 1 of 1

#### Indications for Use Statement

510(k) Number (if known): K140431

#### Device Name: OrthoPediatrics' PediLoc Fragment System

Indications for Use:

OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unlons, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-The-Counter Use

(21 CFR 807 Subpart C) (21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabet标志示Frank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K140431