INTERTAN CHS LIMITED COLLAPSE SET SCREW

K090656 · Smith & Nephew, Inc. · HWC · Jun 3, 2009 · Orthopedic

Device Facts

• Record ID: K090656
• Device Name: INTERTAN CHS LIMITED COLLAPSE SET SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

InterTAN CHS Limited Collapse Set Screw is indicated for: - Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be . more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head). - Intertrochanteric fractures. - Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. - Hip osteotomy . InterTAN CHS Limited Collapse Set Screw is for single use only and is to be used with InterTANY CHS Plating System.

Device Story

The InterTAN CHS Limited Collapse Set Screw is a metallic bone fixation fastener designed as a line addition to the InterTAN CHS Plate System. It functions as a mechanical component to limit allowable collapse and prevent lateral advancement of the plate in proximal femur fracture fixation. Used in clinical settings by orthopedic surgeons, the device is implanted during surgery to stabilize fractures. It provides mechanical support to withstand in vivo loading, aiding in bone healing and fracture stabilization. The device is for single use only.

Clinical Evidence

Bench testing only. Mechanical data indicates the device is capable of withstanding expected in vivo loading without failure.

Technological Characteristics

Metallic bone fixation fastener; designed for use with the InterTAN CHS Plating System to limit collapse and prevent lateral plate advancement. No specific material standards or software components described.

Indications for Use

Indicated for patients with intracapsular proximal femur fractures, intertrochanteric fractures, stable/unstable proximal femur fractures with medial cortex stability, and hip osteotomy. Single use only; for use with InterTAN CHS Plating System.

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

• InterTAN CHS Plate System (K080434)
• DePuy PEAK FX Hip Plate (Limited collapse cap) (K063509)

Submission Summary (Full Text)

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K090656 # 4,

Summary of Safety and Effectiveness Smith & Nephew, Inc. InterTAN® CHS Limited Collapse Set Screw

Contact Person and Address

Shereen Myers Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T [phone]

Date of Summary: March 5, 2009

JUN - 3 2009

Name of Device: Smith & Nephew, Inc. InterTAN® CHS Limited Collapse Set Screw Common Name: Screw Device Classification Name and Reference: 21 CFR 888.3040, smooth or threaded metallic bone fixation fastener

Device Class: Class II Panel Code: Orthopaedics/87 HWC

# Device Description

Subject of this Traditional 510(k) premarket notification is the InterTAN® CHS Limited Collapse Set Screw. The subject device is a line addition to the InterTAN® CHS Plate System cleared via K080434. The Limited Collapse Set Screw is designed to limit the amount of allowable collapse and prevent lateral advancement of the plate.

# Mechanical Testing

A review of the mechanical data indicates that the Limited Collapse Set Screw is capable of withstanding expected in vivo loading without failure.

# Intended Use

InterTAN CHS Limited Collapse Set Screw is indicated for:

- Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be . more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures. �
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be � restored.
- Hip osteotomy .

InterTAN CHS Limited Collapse Set Screw is for single use only and is to be used with InterTANY CHS Plating System.

# Substantial Equivalence Information

The substantial equivalence of the InterTAN® CHS Limited Collapse Set Screw is based on its similarities in indications for use, design features, operational principles, and material composition to the Smith & Nephew, Inc. InterTAN® CHS Plate System (K080434) and the DePuy PEAK FX Hip Plate (Limited collapse cap] (K063509).

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew , Incorporated % Ms. Shereen Myers Regulatory Affairs Specialist I 1450 East Brooks Road Memphis, Tennessee 38116

Re: K090656

Trade/Device Name: InterTAN CHS Limited Collapse Set Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 5, 2009 Received: March 12, 2009

Dear Ms. Myers:

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.

JUN - 3 2009

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

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Page 2-Ms. Shereen Myers

(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/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Boehme

Mark N. Melkerson 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): K090656

Device Name: Smith & Nephew, Inc. InterTAN® CHS Limited Collapse Set Screw

Indications for Use:

InterTAN CHS Limited Collapse Set Screw is indicated for:

- * Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
- Intertrochanteric fractures.
- Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.
- Hip osteotomy .

The Limited Collapse Set Screw is for single use only and is intended to be used with InterTANY CHS Locked Plating System.

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

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)

Onetu

vision Sigt Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090657