SALVATION OSTEOPENIC SCREW

K140408 · Wrightmedicaltechnologyinc · HWC · May 14, 2014 · Orthopedic

Device Facts

• Record ID: K140408
• Device Name: SALVATION OSTEOPENIC SCREW
• Applicant: Wrightmedicaltechnologyinc
• Product Code: HWC · Orthopedic
• Decision Date: May 14, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Salvation™ Osteopenic Screw is indicated for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.

Device Story

SALVATION™ Osteopenic Screw is a non-locking, fully threaded bone screw; manufactured from titanium alloy; solid core design. Intended for surgical fixation of small bone fractures, osteotomies, and arthrodeses; specifically indicated for patients with osteopenic bone. Device is single-use; implanted by surgeons in clinical/OR settings. Mechanical performance verified via torsion, bending, and pull-out strength testing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including torsion, bending, and pull-out strength analysis.

Technological Characteristics

Material: Titanium alloy. Design: Non-locking, fully threaded, solid core bone screw. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones in patients, including those with osteopenic bone.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• VLP FOOT Talus and Percutaneous Calcaneus Bone Plates, VLP Bone Screws; PERI-LOC Ankle Fusion Bone Plates and Instruments (K110670)
• VLP FOOT Plating, Screw System, and Accessories (K090675)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image contains the word "WRIGHT" in large, bold, black letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in smaller, thinner, black letters. To the left of the word "WRIGHT" is a black geometric shape.

K140408 page 1 of

1023 Cherry Road!

901 867 9971
vmt.com

#### 510(K) SUMMARY

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 WMT SALVATION™ Osteopenic Screw.

(a)(1). Submitted By:

Date:

#### Contact Person:

(a)(2). Proprietary Name: Common Name: Classification Name and Reference: Device Product Code, Device Panel:

(a)(3). Predicate Devices:

Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117

May 1, 2014

Val Mýles Regulatory Affairs Specialist Office - [phone] Fax – [phone]

SALVATION™ Osteópenic Screw Bone Screw 21 CFR 888.3040 - Class II HWC: Screw, Fixation, Bone ·

K110670: VLP FOOT Talus and Percutaneous Calcaneus Bone Plates, VLP Bone Screws; PERI-LOC Ankle Fusion Bone Plates and Instruments

K090675: VLP FOOT Plating, Screw System, and Accessories

#### (a)(4). Device Description

The SALVATION™ Osteopenic Screws are non-locking, fully threaded screws offered in various diameters and lengths. All described implants are manufactured from titanium alloy and have a solid core. The implants are single use only devices.

#### (a)(5). Intended Use

The Salvation™ Osteopenic Screw is indicated for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.

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#### (a)(6). Technological Characteristics Comparison

The Salvation™ Osteopenic Screw is technologically substantially equivalent to the predicate device.

#### (b)(1). Substantial Equivalence - Non-Clinical Evidence

Torsion testing and testing rationales related to bending and pull-out strength were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system.

The safety and effectiveness of the SALVATION™ Osteopenic Screw is adequately supported by the mechanical testing, testing rationales, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.

#### (b)(2). Substantial Equivalence – Clinical Evidence

N/A

#### (b){3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its body and wings.

#### 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

May 14, 2014

Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K140408

Trade/Device Name: SALVATION™ Osteopenic Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 2, 2014 Received: May 5, 2014

Dear Ms. Myles:

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 -- Ms. Val Myles

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" (2) CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Ronald P. Jean -S for

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

Enclosure

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#### K140408

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510{k} Number (if known)

K140408

Device Name SALVATION™ Osteopenic Screw

#### Indications for Use (Describe)

The Salvation™ Osteopenic Screw is indicated for the treatment of fractornies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

. .

PRC Publishing Bervices [phone]

## PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth L. Frank -S

Division of Orthopedic Devices

FORM FDA 3881 (1/14)

E3 - 1

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