MINI MAXLOCK EXTREME PLATING SYSTEM

K120157 · Orthohelix Surgical Designs, Inc. · HRS · Apr 10, 2012 · Orthopedic

Device Facts

• Record ID: K120157
• Device Name: MINI MAXLOCK EXTREME PLATING SYSTEM
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Apr 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

Device Story

The Mini MaxLock Extreme® Plating System is a metallic bone fixation system consisting of plates and screws. It is used by orthopedic surgeons in a clinical/surgical setting to stabilize small bone fractures, fusions (including MTP joint fusions), and osteotomies. The device provides mechanical stabilization to bone fragments to facilitate healing. It is a passive implantable device; no electronic or software components are involved. The system is an expansion of existing cleared technology, utilizing established materials to provide structural support for bone repair.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by mechanical testing and finite element analysis comparing subject device to predicate devices.

Technological Characteristics

Materials: Titanium Alloy and PEEK. Components: Fixation plates and screws. Principle: Mechanical bone fixation/stabilization. Form factor: Small bone plating system. No energy source, connectivity, or software.

Indications for Use

Indicated for stabilization and repair of fractures, fusions, and osteotomies of small bones and bone fragments in patients requiring surgical fixation.

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

• Mini MaxLock Extreme® Plating System (K101962)
• Mini Variable System (K111041)

Submission Summary (Full Text)

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## 510(k) SUMMARY

### Submitter Information

Submitter's Name: Address:

Telephone Number: Fax Number: Prepared By: Contact Person: Date Prepared:

### Device Information

Trade Name:

Common Name:

Classification Name:

Device Classification:

Material Composition:

Device Description:

Intended Use:

#### Substantial Equivalence:

OrthoHelix Surgical Designs, Inc. 1065 Medina Rd, Suite 500 Medina, Ohio 44256 330-869-9562 330-247-1598 Brian Hockett, Liz Altenau Derek Lewis 12/28/11

### Mini MaxLock Extreme® Plating System

Fixation Plates and Screws

Plate, Fixation, Bone

Single/multiple component metallic bone fixation appliances (Class II per 21 CFR 888.3030) Panel: Orthopedic, Product Code: HRS Smooth or threaded metallic bone fixation fastener (Class II per 21 CFR 888.3040)

Panel: Orthopedic, Product Code: HWC ·

Titanium Alloy, PEEK

The submission is a modification to the Mini MaxLock Extreme® Plating System to add Mini MTP Plates. This submission also includes the ISO plate that was previously cleared through internal documentation. No modifications were made to the existing plates or screws. The OrthoHelix Mini MTP Plates are designed for 18 MTP joint fusions.

The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The new Mini MaxLock Extreme® Plating System is substantially equivalent to the existing OrthoHelix Mini MaxLock Extreme® Plating System (K101962) and the Mini Variable System (K111041). Calculations, mechanical testing and finite element analysis comparing the strength of the subject and predicate devices were performed and the results support substantial equivalence. Due to similarities in indications, design, and materials, no other testing was required. No new issues of safety and effectiveness have been raised.

# APR 1 0 2012

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APR 1 0 2012

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

Re: K120157

Trade/Device Name: Mini MaxLock Extreme® 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: March 23, 2012 Received: March 26, 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

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## Page 2 - Mr. Derek Lewis

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/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.

Erin d. Keith

for

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

510(k) Number (if known):

Device Name: Mini MaxLock Extreme® Plating System

Indications for Use:

The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David

Division Sign-Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K120157