INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW

K080434 · Smith & Nephew, Inc. · JDO · Apr 10, 2008 · Orthopedic

Device Facts

• Record ID: K080434
• Device Name: INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: JDO · Orthopedic
• Decision Date: Apr 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

InterTANTM CHS Proximal Femur Locking Bone Plates and Bone Screws are indicated for: 1. ) 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). 2.) Intertrochanteric fractures. 3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. 4.) Hip osteotomy Components in the InterTANTM CHS Plating System are for single use only.

Device Story

InterTAN CHS Plating System addresses proximal femur fractures; system includes bone plates, lag screws, compression screws, and accessories. Plates feature contoured locking design with screw-to-plate locking mechanism along shaft to maintain fracture reduction; various hole configurations and barrel angles available. Used by orthopedic surgeons in clinical/surgical settings for internal fixation. Device provides mechanical stability to bone fragments; aids healing by holding fracture reduction. Components are single-use.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation system; materials include stainless steel and titanium. Features contoured locking bone plates with screw-to-plate locking mechanism, lag screws, and compression screws. Single-use. No software or electronic components.

Indications for Use

Indicated for patients with proximal femur fractures, including intracapsular, intertrochanteric, and stable/unstable fractures where medial cortex stability is restorable, and for hip osteotomy. Contraindicated for certain high intracapsular fractures where prosthesis is preferred to mitigate nonunion or AVN risk.

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

• PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws (K072818)
• PERI-LOC Periarticular Locked Plating System (K033669)
• TriGen InterTAN Nail (K040212)
• Smith & Nephew Compression Hip Screw (K993289)
• Orthofix Gotfried Pc.C.P (K983814)
• DePuy Ace Captured Hip Screw (K813554)

Submission Summary (Full Text)

{0}------------------------------------------------

K080434

### 510(k) Summary of Safety and Effectiveness InterTANTM CHS Plating System Plates, Lag Screws, Compression Screws and Accessories

APR 1 0 2008

| Submitted By: | Smith & Nephew, Inc., Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 15, 2008 |
| Contact Person: | Elizabeth Miller, Regulatory Affairs Project Manager<br>Tel: [phone] Fax: [phone] |
| Proprietary Name: | InterTANTM CHS Plating System -<br>Plates, Lag Screws, Compression Screws and<br>Accessories |
| Common Name: | Bone Plates and Bone Screws |
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple component metallic<br>bone fixation appliances and accessories - Class II<br>21 CFR 888.3040, smooth or threaded metallic bone<br>fixation fastener - Class II |
| Device Product Code and Panel Code: | KTT, HWC / Orthopedics / 87 |

#### Device Description:

The design of the InterTAN™ CHS Plating System is based on design features of the following currently marketed products: PERJ-IJOC™ Periarticular Locked Plating System, TriGen InterTAN Nail and CHS. InterTAN™CHS System is designed to address fractures of the proximal femur. System components include bone plates, lag screws, compression screws, and associated accessories. Like the predicate devices listed below, the subject components include various hole configurations and barrel angles of the contoured locking bone plates and various lengths of the lag/compression screws made from stainless steel and titanium. Further InterTAN™ CHS femoral locking bone plates, incorporate a screw-to-plate locking feature along the shaft of the plate which forms a locked, fixed angle construct to aid in holding fracture reduction.

#### Intended Use:

InterTANTM CHS Proximal Femur Locking Bone Plates and Bone Screws are indicated for: 1. ) 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).

2.) Intertrochanteric fractures.

3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored. 4.) Hip osteotomy

Components in the InterTANTM CHS Plating System are for single use only.

{1}------------------------------------------------

#### Technological Characteristics:

Components comprising the InterTANTM CHS Plating System are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics.

#### Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition.

- PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws -. K072818
- PERI-LOCTM Periarticular Locked Plating System K033669 .
- . TriGen InterTAN Nail- K040212
- Smith & Nephew Compression Hip Screw- K993289 .
- Orthofix Gotfried Pc.C.P .- K983814 .
- DePuy Ace Captured Hip Screw- K813554 .

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Elizabeth Miller Project Manager, Regulatory Affairs 1450 Brooks Rd. Memphis, TN 38116

Re: K080434 Trade/Device Name: InterTANTM CHS 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: JDO, KTT Dated: February 15, 2008 Received: February 19, 2008

Dear Ms. Miller:

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.

APR 10 2008

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 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.

{3}------------------------------------------------

### Page 2 - Ms. Elizabeth Miller

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use Statement

| 510(k) Number (if known): | K080434 |
|---------------------------|---------|
|---------------------------|---------|

InterTANTM CHS Plating System -Device Name:

Indications for Use:

InterTANTM CHS Proximal Femur Locking Bone Plates and Bone Screws are indicated for:

1.) Intracapsular fractures of the proximal femur

2.) Intertrochanteric fractures.

3.) Stable and unstable fractures of the proximal femur in which medial cortex stability can be restored.

4.) Hip osteotomy

* For cortain high intracapsular 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.

Components in the InterTANTM CHS Plating System are for single use only.

Prescription Use X AND/OR (Part 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

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

e of Device Evaluation (ODE) Concurrence of C

Neil R.P. Ryder - Asmkm

Division of General, Restorative, and Neurological Devices

**510(k) Number** K080434