EVOLVE EPS ORTHOLOC

K102352 · Wrightmedicaltechnologyinc · HRS · Dec 2, 2010 · Orthopedic

Device Facts

• Record ID: K102352
• Device Name: EVOLVE EPS ORTHOLOC
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Dec 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVOLVE® EPS ORTHOLOC™ is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

Device Story

The EVOLVE® EPS ORTHOLOC™ System is a metallic bone fixation system consisting of bone plates and screws. It is used by orthopedic surgeons in clinical settings to stabilize fractures, osteotomies, and non-unions of the olecranon, humerus, radius, and ulna. The system functions through mechanical fixation; screws are inserted into bone, optionally through plates, to provide structural support and promote healing. This iteration introduces modified screw lengths, shorter plate options, and a modified driver-screw interface. The device is purely mechanical; it does not involve software, algorithms, or electronic components. It provides clinical benefit by enabling rigid internal fixation of bone segments.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including ultimate torque testing, pull-out data, and off-axis locking comparison.

Technological Characteristics

Metallic bone fixation system (plates and screws). Materials are identical to the predicate. Features include modified screw lengths, shorter plate lengths, and modified screw head drive interface. Mechanical fixation principle. No software, electronics, or energy sources.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the olecranon, humerus, radius, and ulna in patients requiring orthopedic bone 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

• EVOLVE® EPS ORTHOLOC™ System (K100146)

Submission Summary (Full Text)

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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® EPS ORTHOLOC™ System.

| A.1. Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Rd<br>Arlington, TN 38002 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Date: | August 9, 2010 |
| Contact Person: | Kelsey Lee<br>Regulatory Affairs Specialist I<br>[phone] |
| A.2. Proprietary Name: | EVOLVE® EPS ORTHOLOCTM |
| Common Name: | Bone Plate System/Bone Screw System |
| Device Classification Regulation: | 21 CFR 888.3030--Class II |
| Device Product Code & Panel: | HRS: Single/multiple component metallic bone<br>fixation appliances and accessories.<br>HWC: Screw, fixation, bone<br>87 Orthopedics |
| A.3. Predicate Device: | EVOLVE® EPS ORTHOLOC™ System<br>(K100146) |

### A.4. Device Description

The EVOLVE® EPS OTHOLOC™ System is extended to offer two longer screw lengths and four shorter plates. The driver-screw interface is also being modified. The plates are identical to the predicate in hole/slot placement and depth, plate shape and material. The subject screws have identical profile and thread form. The screws may be used with or without the plates.

The design features of the EVOLVE® EPS ORTHOLOC™ system are substantially equivalent to the design features of the predicate EVOLVE® EPS ORTHOLOC™

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#### A.5. Intended Use

The subject EVOLVE® EPS ORTHOLOC™ system has the same intended use as the predicate.

The EVOLVE® EPS ORTHOLOC™ is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

#### A.6. Technological Characteristics Comparison

The subject EVOLVE® EPS ORTHOLOC™ and the legally marketed predicate EVOLVE® EPS ORTHOLOC™ System have identical indications, utilize the same instruments, and are manufactured out of the same materials. The subject and predicate components are fully compatible.

The subject EVOLVE® EPS ORTHOLOC™ adds two additional lengths of screws, four shorter plates, offers a modified drive feature on the screw heads and may be used with or without the plates.

#### B.1. Substantial Equivalence - Non-Clinical Evidence

Substantial equivalence was shown through ultimate torque testing, pull-out data, and offaxis locking comparison. The results of the tests show that the subject EVOLVE® EPS ORTHOLOCTM can be expected to perform at least as well as the legally marketed predicate EVOLVE® EPS ORTHOLOCTM

The safety and effectiveness of the subject EVOLVE® EPS ORTHOLOC™ System is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within this Premarket Notification.

#### B.2. Substantial Equivalence - Clinical Evidence

N/A

#### B.3. Substantial Equivalence - Conclusions

Substantial equivalence is shown through ultimate torque testing, pull out data and off-axis locking comparison. The materials, indications, screw and thread profiles, and plate shapes and features are identical between the subject and predicate. The subject and predicate differ in drive feature depth, screw lengths and plate lengths; no new questions concerning safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. c/o Ms. Kelsey Lee Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

DEC 2 2010

Re: K102352

Trade/Device Name: EVOLVE® EPS ORTHOLOCTM 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: October 29, 2010 Received: November 2, 2010 ・・ — ・

Dear Ms. Lee:

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

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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.

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

For
Mark N. Melkerson

Mark 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): KIO 2.3 5 2

Device Name: EVOLVE® EPS ORTHOLOC™ System

Indications For Use:

The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

Prescription Use xxx (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign

(Division Sign) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102352