ORTHOLOC 3DSI LOCKING SCREWS

K113339 · Wrightmedicaltechnologyinc · HRS · Dec 12, 2011 · Orthopedic

Device Facts

• Record ID: K113339
• Device Name: ORTHOLOC 3DSI LOCKING SCREWS
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HRS · Orthopedic
• Decision Date: Dec 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

ORTHOLOC™ 3DSi Locking Screws are orthopedic implants used for bone fixation. Manufactured from implant-grade stainless steel, these screws feature cortical and cancellous thread forms in various lengths and diameters. Used by orthopedic surgeons in clinical or surgical settings to stabilize fractures, osteotomies, or nonunions of the olecranon, humerus, radius, and ulna. The device functions as a mechanical fixation component; it is implanted during surgery to provide structural support to bone segments, facilitating healing. No software or electronic components are involved.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical evidence, including material composition and design characteristic comparisons.

Technological Characteristics

Material: Stainless steel conforming to ASTM F2229. Form factor: Locking screws with cortical and cancellous thread forms. No software, electronics, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for fixation of fractures, osteotomies, and nonunions of the olecranon, humerus, radius, and ulna in patients requiring orthopedic surgical intervention.

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 (K102352)

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 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the ORTHOLOC™ 3DSi Locking Screws.

| A.1. Submitted By: | Wright Medical Technology, Inc.<br>5677 Airline Rd<br>Arlington, TN 38002 |
|-----------------------------------|---------------------------------------------------------------------------|
| Date: | October 28, 2011 |
| Contact Person: | Peggy S. Rivers<br>Regulatory Affairs Specialist<br>[phone] |
| A.2. Proprietary Name: | ORTHOLOC™ 3DSi Locking Screws |
| Common Name: | Locking Screws |
| Device Classification Regulation: | 21 CFR 888.3030—Class II |
| Device Product Code & Panel: | HRS: Plate, Fixation Bone<br>87 Orthopedics |
| A.3. Predicate Device: | K102352—EVOLVE® EPS ORTHOLOC™ System |

#### A.4. Device Description

The ORTHOLOCM 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

These screws are manufactured from stainless steel conforming to ASTM F2229.

The design features of the ORTHOLOC™ 3DSi Locking Screws are identical to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System Locking Screws.

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K113339 Page 2/2 **WRIGHT.**

# A.5. Intended Use

The system indications for both subject ORTHOLOC™ 3DSi Locking Screws and predicate EVOLVE® EPS ORTHOLOC™ (K102352) are identical.

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

#### A.6. Technological Characteristics Comparison

The subject ORTHOLOC™ 3DSi Locking screws are identical to the previously cleared EVOLVE® EPS ORTHOLOC™ Locking screws (K102352) with only minor change to feature call-outs on the engineering drawing.

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

Substantial equivalence is demonstrated through materials information and a composition of design characteristics.

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

N/A

# B.3. Substantial Equivalence - Conclusions

The subject screws are identical in indication for use, diameter, size range and material to the predicate. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.

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

DEC 1 2 2011

Wright Medical Technology, Inc. % Ms. Peggy S. Rivers 5677 Airline Rd. Arlington, TN 38002

Re: K113339

Trade/Device Name: Ortholoc™ 3DSi Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS. HWC Dated: November 11", 2011 Received: November 14th, 2011

Dear Ms. Rivers:

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.

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Page 2 - Ms. Peggy S. Rivers

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 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/ReportalProblem/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 yours.

Sincerely yours,

Evin S. Keith

J 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: EVOLVE® EPS ORTHOLOC ™ System with ORTHOLOC™ 3DSi Locking Screws

Indications For Use:

EVOLVE® EPS ORTHOLOC™ System: Intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, and ulna

Prescription Use X (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)

Michael Chas

fn mxm

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

510(k) Number K 113339

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