SMITH & NEPHEW CANNULATED SCREWS AND WASHERS

K111994 · Smith & Nephew, Inc. · HWC · Oct 11, 2011 · Orthopedic

Device Facts

• Record ID: K111994
• Device Name: SMITH & NEPHEW CANNULATED SCREWS AND WASHERS
• Applicant: Smith & Nephew, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

Device Story

Cannulated screws and washers provide internal bone fixation. Screws feature fluted tips for self-tapping/drilling and hexagonal heads; cannulated design allows placement over guidewires. Used in clinical settings by orthopedic surgeons for fracture fixation, osteotomies, and arthrodesis. Washers extend surface area of screw heads. Device provides mechanical stability to bone fragments during healing, potentially improving patient recovery outcomes. Operation involves manual insertion by surgeon.

Clinical Evidence

Bench testing only. Performance testing included three-point bend fatigue, static torsional, and axial pullout tests for 4.0mm screws compared to 3.0mm SS predicate. Four-point bend fatigue, static torsional, and axial pullout tests were performed for 5.5mm screws compared to Synthes 4.5mm Ti predicate. Results confirmed subject devices perform equal to or better than predicate devices.

Technological Characteristics

Metallic bone fixation fasteners (screws and washers). Materials: Titanium alloy and stainless steel. Design: Cannulated, fluted tips, hexagonal heads, varying diameters (4.0mm-8.0mm) and lengths. Mechanical performance validated via fatigue, torsional, and axial pullout testing. Non-software device.

Indications for Use

Indicated for adult and pediatric patients requiring fixation of pelvic, small, and long bone fractures, including tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, hand/foot bones, and calcaneus. Also indicated for hip arthrodesis, provisional hole fixation, and reconstruction, osteotomy, and arthrodesis of small bones/joints (e.g., scaphoid, carpal bones, patella, ulnar styloid, capitellum, radial head/styloid) and foot/ankle joint fusions.

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

• Smith & Nephew 3.0 Cannulated Screw, SS (K090675)
• 4.5 Headless Compression Screw (cannulated), Ti (K080943)
• Osteomed Headless Cannulated Screw System (K063298)
• Pioneer Cannulated Screw System (K102903)
• Synthes 6.5 mm Cannulated Screw (K021932)
• Synthes Spherical Washers (K052483)
• Cannulated Screw System, Washer (K003496)

Submission Summary (Full Text)

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K111994 # '1/4

OCT

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1572

## 510(k) Summary of Safety and Effectiveness Smith & Nephew Cannulated Screws and Washers

| Submitted By: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 6, 2011 |
| Contact Person: | Maureen Whitson, Senior Regulatory Affairs Specialist<br>Tel: [phone], Fax [phone] |
| Proprietary Name: | Smith & Nephew Cannulated Screws and Washers |
| Common Name: | Cannulated Screws and Washers |
| Device Classification Name and<br>Reference: | 21 CFR 888.3040 Smooth or threaded metallic bone<br>fixation fastener<br>and<br>21 CFR 888.3030 Single/multiple component<br>metallic bone fixation appliances and accessories |
| Device Class: | Class II |
| Panel Code: | Orthopedics/ 87 - HWC and NDG |

#### Device Description

The subject of this Traditional 510(k) premarket notification is to expand the indications of the already existing, cleared Smith & Nephew Cannulated Screws and Washers by adding osteotomies and arthrodesis. The subject devices are part of the Smith and Nephew Bone Plate System cleared under 510(k) number K993106 and K060736 with the same original indications but the subject 4.0mm, 5.5mm, 6.5mm, 7.0mm and 8.0mm cannulated screws and associated washers have additional indications independent of the Bone Plate System.

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KI111994 # 2/4

The screws vary in diameter, length and thread length; have fluted screw tips for self-tapping and self-drilling and have a hexagonal screw heads. The screws may be used with bone washers to extend the surface area of the head if needed. These screws are cannulated to allow the screws to be accurately positioned with the use of a guidewire instrument. The device offering consist of diameters of 4.0mm, 5.5mm, 7.0mm and 8.0mm in titlanium allov and stainless steel.

| Diameter | Length Range | Thread Length Range | Material |
|----------|--------------|---------------------------------|----------|
| 4mm | 20mm - 70mm | 8mm - 15mm | Ti |
| 4mm | 10mm - 70mm | 5mm - 15mm and fully threaded | SS |
| 5.5mm | 20mm - 120mm | 8mm - 32mm and fully threaded | Ti |
| 5.5mm | 20mm - 120mm | 5mm - 15mm and fully threaded | SS |
| 6.5mm | 30mm - 180mm | 22mm - 46mm and fully threaded | Ti |
| 6.5mm | 30mm - 150mm | 22mm - 46mm and fully threaded | SS |
| 7mm | 30mm - 150mm | 16mm - 32mm and fully threaded | Ti |
| 7mm | 30mm - 150mm | 16mm - 32mm and fully threaded | SS |
| 8mm | 40mm - 180mm | 22mm - 46mm and fully threaded | Ti |
| 8mm | 40mm - 180mm | 22mm - 180mm and fully threaded | SS |

#### Smith & Nephew Cannulated Screw Size Ranges

Summary of Cannulated Screw Accessory Washers

| Accessory<br>Device | Type | Size Range | Material |
|---------------------|-----------|-------------------------------------------------------|-----------|
| Washers | Round | 4.0mm to 8.0mm Internal Diameter | Ti and SS |
| Washer | Butterfly | 8.0mm Internal Diameter and Overall<br>Length 21.7mm | Ti and SS |

#### Intended Use

Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

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K111994 #3/4

## Technological Characteristics

The Smith & Nephew Cannulated Screws and Washers are very similar to legally marketed devices cleared under K090675, K080943, K063298, K102903, K021932, K052483, and K003496. When compared to the predicates, the devices share very similar indications for use and intended use, are manufactured from similar materials and incorporate similar technical design characteristics.

A review of the mechanical data indicates that the Smith & Nephew Cannulated Screws are capable of withstanding expected in vivo loading without failure. The performance bench testing consisted of a three point bend fatigue, static torsional and axial pullout bend test, comparing the S&N 4.0mm screws (Ti and SS) to the S&N 3.0mm SS screw and the results show the subject screw would perform equal or better that the predicate screws. The performance bench testing also consisted of a four point bend fatigue, static torsional and axial pullout bend test, comparing the S&N 5.5mm screws (Ti and SS) to the Synthes titanium 4.5mm screw and the results show the subject screws would perform equal or better than the predicate screws.

### Substantial Equivalence Information:

The substantial equivalence of the Smith & Nephew Cannulated Screws and Washers is based on its similarities in indications for use, design features, operational principles, and material composition to the devices listed below.

| Manufacturer | Description | Submission<br>Number |
|----------------|-------------------------------------------------|----------------------|
| Smith & Nephew | Smith & Nephew 3.0 Cannulated Screw, SS | K090675 |
| Synthes | 4.5 Headless Compression Screw (cannulated), Ti | K080943 |
| Osteomed | Osteomed Headless Cannulated Screw System | K063298 |
| Pioneer | Pioneer Cannulated Screw System | K102903 |
| Synthes | Synthes 6.5 mm Cannulated Screw | K021932 |
| Synthes | Synthes Spherical Washers | K052483 |
| Pioneer | Cannulated Screw System, Washer | K003496 |

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K 11119944444

Similarities and Difference between the Subject Devices and predicate Devices

| Similarities |
|--------------|
| |

| | Similarities of Subjects to Predicates |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Design | Similar in dimensions (screw diameter, screw length ) |
| Features | Both predicate and subject are cannulated, both have<br>varying thread lengths, both are offered with accessory bone<br>screw washers |
| Material | Both are offered in SS and Ti Alloy |
| Indications for Use | Both are indicated for fractures, osteotomies and arthrodesis<br>of various small bones and joints |

# Differences

| | Differences of Subjects to<br>Predicates | Rationale why this difference does not affect<br>the Safety and Effectiveness |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Screw head dimensions may<br>have slight size differences<br>and some may be smooth<br>and others may be threaded<br>or "headless" | Headless screws are used for counter-<br>sinking to prevent the implanted screw from<br>sitting too proud on the bone surface and are<br>for surgeon preference. The screw head size<br>does not affect the performance of the<br>implanted screw in regard to the mechanical<br>stresses on the shaft of the screws. |
| Design | Varying screw thread length | The thread lengths do not affect the<br>mechanical stresses of the implanted screws.<br>Their application is chosen based on surgeon<br>preference and on what kind of fracture,<br>osteotomy or arthrodesis in which the screw<br>will be used. |
| Chemical<br>Composition | The predicate Synthes<br>4.5mm Ti alloy screw is made<br>from Ti -6Aluminum -7<br>Niobium instead of Ti 6<br>Aluminum- 4Vanadium | The niobium was substituted for the<br>vanadium as the beta stabilizing element in<br>this alloy. According to the manufacturer of<br>the raw material, the mechanical properties<br>are almost identical and it is a common alloy<br>used in orthopedic implants. Our bench<br>testing shows the subject screws performed<br>equal or better than the predicate screw<br>made with this material |

.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

#### Public Health Service

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

Smith & Nephew, Inc. % Ms. Maureen Whitson Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova. Tennessee 38106

OCT 1 1 2011

Re: K111994

Trade/Device Name: Cannulated Screws and Washers Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. NDG Dated: July 12, 2011 Received: July 13, 2011

Dear Ms. Whitson:

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.

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. Maureen Whitson

forth in the quality systems (OS) 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.html 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/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 Small Manufacturers, international and Consumer Assistance 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,

Pon Nth

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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# Premarket Notification Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Cannulated Screws and Washers

Indications for Use:

Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones, treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

AND/OR

Prescription Use

(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)

urrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number