HA COATED LAG SCREW

K050849 · Smith & Nephew, Inc. · KTT · May 4, 2005 · Orthopedic

Device Facts

• Record ID: K050849
• Device Name: HA COATED LAG SCREW
• Applicant: Smith & Nephew, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hydroxylapatite (HA) Coated Lag Screw is used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications: Compression Hip Screws/ IMHS - Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.) - Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity. - Osteotomies for patients with diseases or deformities of the hip. - Hip arthrodesis. - Supracondylar fractures and distal femoral fractures using a supracondylar plate. - Ipsilateral femoral shaft/neck fractures (long IMHS only). HA Coated Lag Screws are for single use only.

Device Story

HA Coated Lag Screws are metallic bone fixation devices; constructed from 316L stainless steel or Titanium-6Al-4V; coated with Hydroxylapatite (HA). Used by surgeons in clinical settings to provide purchase within femoral head or condyles; supports fracture compression when used with Compression Hip Screw or Intramedullary Hip Screw systems. Device provides mechanical stability for bone healing; intended for single use. Clinical benefit derived from secure fixation of femoral fractures and osteotomies.

Clinical Evidence

Bench testing only. Mechanical test data indicates the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading without failure.

Technological Characteristics

Metallic bone fixation appliance; materials: 316L stainless steel or Titanium-6Al-4V; surface treatment: Hydroxylapatite (HA) coating. Form factor: screw for use with hip screw systems. Mechanical fixation principle. Single-use device.

Indications for Use

Indicated for adult patients requiring internal fixation for intracapular femoral neck fractures, trochanteric/subtrochanteric fractures, hip osteotomies, hip arthrodesis, supracondylar/distal femoral fractures, or ipsilateral femoral shaft/neck fractures. Used in conjunction with Compression Hip Screw or Intramedullary Hip Screw systems.

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

• Smith & Nephew Trauma Internal Fixation System (K993289)
• Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337)
• Smith & Nephew Jet-X HA Coated Half Pins (K033289)
• Smith & Nephew Jet-X HA Coated Half Pins (K023921)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effe

### Contact Person and Address

MAY - 4 2005 Pate of Summary: April 1, 2005

David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: HA Coated Lag Screws Common Name: Lag Screws

#### Device Description

HA (Hydroxylapatite) Coated Lag Screws are large metallic screw devices that are used in conjunction with Compression Hip Screw Systems and Intramedullary Hip Screw Systems to obtain purchase inside the femoral head or condyles to help provide support for compression of the fracture. HA Coated Lag Screws are available in various sizes made from either 316L stainless steel or Titanium-6Al-4V metal materials.

#### Device Classification

21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories - Class II

#### Mechanical and Clinical Data

A review of the mechanical test data indicated that the HA Coated Lag Screws are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

#### Indications for Use

The Hydroxyapatite (HA) Coated Lag Screws are used with the Compression Hip Screw Systems and Intramedullary Hip Screw (IMHS) Systems in adult patients for the following indications:

#### Compression Hip Screws/ IMHS

- Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to 1. select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
- 2. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
- 3. Osteotomies for patients with diseases or deformities of the hip.
- 4. Hip arthrodesis.
- Supracondylar fractures and distal femoral fractures using a supracondylar plate. ട്.
- Ipsilateral femoral shaft/neck fractures (long IMHS only). 6.

#### Substantial Equivalence Information

Substantial equivalence of the HA Coated Lag Screw is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices -Smith & Nephew Trauma Internal Fixation System (K993289), Smith & Nephew HA Global Taper Tapered (Synergy) Hip System (K970337), and Smith & Nephew Jet-X HA Coated Half Pins (K033289 and K023921).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2005

Mr. David Henley Senior Regulatory/Clinical Affairs Specialist Smith & Nephew, Inc. Orthopaedics Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K050849

Trade/Device Name: HA Coated Lag Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: April 1, 2005 Received: April 4, 2005

Dear Mr Henley:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have reviewe a your we determined the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass backed in 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 nu v ooth rot 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 eonly of provisions see, 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to saon adam 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 r was oo advisor and a determination that your device complies with other requirements of the Act or that 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); an the Ave of equirements) ; good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800); gover 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough inding of substantial equivalence of your device to a legally premaired notification: "The Privation 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 11 you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your 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,

Miriam C. Provost, Ph.D.
Acting Director
Division of General, Restorative
and Neurological Devices

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Premarket Notification Indications for Use Statement

510(k) Number (if known): _

HA Coated Lag Screws Device Name:

Indications for Use:

The Hydroxylapatite (HA) Coated Lag Screw is used with the Compression Hip Screw Systems rrie Tyuloxytapulle In A Seated Signers in adult patients for the following indications:

Compression Hip Screws/ IMHS

- Intracapular fractures of the femoral neck. (For high subcapsular fractures it may be more 1. infliatapular fractures of the sembled of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
- a avascular necrosis or the lombratives with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
- Osteotomies for patients with diseases or deformities of the hip. 3.
- Hip arthrodesis. 4.
- r lip at frirousers: ട്.
- ipsilateral femoral shaft/neck fractures (long IMHS only) 6.

HA Coated Lag Screws are for single use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Styp Rhodes

Division of Gener A Restorative. and Neurological Devic

510(k) Number K050849