MAXLOCK EXTREME SYSTEM

K113048 · Orthohelix Surgical Designs, Inc. · HRS · Jan 30, 2012 · Orthopedic

Device Facts

• Record ID: K113048
• Device Name: MAXLOCK EXTREME SYSTEM
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The MaxLock Extreme® System is indicated for the following: The Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. The Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

Device Story

MaxLock Extreme® System comprises metallic bone plates and screws for fracture fixation, osteotomy, and arthrodesis. Components are implanted by surgeons in clinical settings to stabilize bone fragments. System includes specialized modules (Universal, Clavicle, Foot, Distal Radius) to accommodate various anatomical sites. Device provides mechanical stability to facilitate bone healing. No software or electronic components involved.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, finite element analysis, and mathematical analyses.

Technological Characteristics

Implantable bone fixation system consisting of plates and screws. Materials: Titanium alloy and PEEK. Mechanical fixation principle. No energy source, software, or connectivity.

Indications for Use

Indicated for adult and pediatric patients requiring internal fixation of pelvic, small, and long bone fractures, osteotomies, or arthrodesis. Specific modules cover tibia, fibula, femur, humerus, ulna, radius, clavicle, and bones of the hand, wrist, foot, and ankle.

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

• MaxLock Extreme® System (K07362)
• MaxLock Extreme® System (K090289)
• MaxLock Extreme® System (K093900)
• MaxLock Extreme® System (K100618)
• MaxLock Extreme® System (K102156)
• Biomet Forerunner System (K092528)
• OrthoHelix Calcaneal Trauma System (K061400)
• Biomet/E.B.I. OptiLock Periarticular Plating System (K061098)

Submission Summary (Full Text)

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# JAN 3 0 2012

ﺔ ﺍﻟﺘ t

K 11 30 48

## 510(k) SUMMARY

# Submitter Information

| Submitter's Name: | OrthoHelix Surgical Designs, Inc. |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1065 Medina Rd, Suite 500<br>Medina, Ohio 44256 |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Rebecca DiLiberto |
| Contact Person: | Derek Lewis |
| Date Prepared: | 1/19/12 |
| Device Information | |
| Trade Name: | MaxLock Extreme® System |
| Common Name: | Plates/Screws |
| Classification Name: | Plate, Fixation, Bone and Screw, Fixation, Bone |
| Device Classification: | Single/multiple component metallic bone fixation appliances (Class II<br>per 21 CFR 888.3030 and 888.3040)<br>Panel: Orthopedic, Product Code: HRS/HWC |
| Predicate Device: | The MaxLock, Extreme® System is equivalent to current legally<br>marketed devices. |
| Material Composition: | Titanium Alloy, PEEK |
| Device Description: | The MaxLock Extreme® System consists of various size plates and<br>screws used to stabilize and aid in the fusion or repair of fractured<br>bones and bone fragments. The plates are offered in different lengths<br>and sizes. The screws are offered in different diameters and lengths.<br>All implantable components are manufactured from implant grade<br>titanium alloy or PEEK |
| Indications for Use: | The MaxLock Extreme® System is indicated for the following:<br>The Universal Module is indicated for use in adult or pediatric<br>patients as indicated for pelvic, small and long bone fracture<br>fixation and fixation of bones that have been surgically prepared<br>(osteotomy) for correction of deformity or arthrodesis. Indications<br>for use include internal fixation of the tibia, fibula, femur,<br>humerus, ulna, radius, and bones in the hand, wrist, foot and<br>ankle.The Clavicle Module is indicated for fractures, fusions and<br>osteotomies of the clavicle and bones in the hand, wrist, foot and<br>ankle.The Foot Module is indicated for fractures, fusions and<br>osteotomies of bones in the hand, wrist, foot and ankle in<br>pediatric and adult patients.The Distal Radius Module is indicated for fractures and<br>osteotomies of the distal radius in adult patients. |

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#### Substantial Equivalence:

The MaxLock Extreme® System is substantially equivalent to previous versions of the MaxLock Extreme® System released under K-numbers: K07362, K090289, K093900, K100618, and K102156 as well as the Biomet Forerunner System (K092528), the OrthoHelix Calcaneal Trauma System (K061400) and the Biomet/E.B.I. OptiLock Periarticular Plating System (K061098). Substantial equivalence was demonstrated with mechanical testing, finite element analysis and mathematical analyses. No new issues of safety and effectiveness have been raised.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

OrthoHelix Surgical Designs, Incorporated % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina. Ohio 44256

JAN 3 0 2012

Re: K113048

Trade/Device Name: Maxlock Extreme™ 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: January 3, 2012 Received: January 4, 2012

Dear Mr. Lewis:

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 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

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### Page 2 - Mr. Derek Lewis

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.

For Peter DV
N. Meller Der CC

Mark N. Melkerson 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

4113.049 510(k) Number (if known):

Device Name: MaxLock Extreme® System

Indications for Use:

The MaxLock Extreme System is indicated for the following:

- The Universal Module is indicated for use in adult or pediatric patients as indicated for o pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle.
- The Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and o bones in the hand, wrist, foot and ankle.
- The Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, O wrist, foot and ankle in pediatric and adult patients.
- The Distal Radius Module is indicated for fractures and osteotomies of the distal radius in o adult patients.

Prescription Use X

AND/OR

Over-The-Counter-Use_

(Part 21 CFR 801 Subpart D)

(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)

Deale
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

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(113048 510(k) Number