SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES

K090675 · Smith & Nephew, Inc. · HRS · Jun 4, 2009 · Orthopedic

Device Facts

• Record ID: K090675
• Device Name: SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies, Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand. Pins and wires are indicated for pelvic, small and long bone fracture fixation.

Device Story

System of metallic bone fixation components including plates, cannulated screws, headless cannulated screws, QFX screws, K-wires, cortex screws, and locking cortex screws. Used by surgeons in clinical settings for orthopedic procedures involving small bone fractures, non-unions, osteotomies, and arthrodeses. Components provide mechanical stabilization of bone fragments to facilitate healing. Surgeon selects appropriate hardware based on fracture site and bone quality; implants are surgically placed to maintain alignment during the bone healing process. Benefits include restoration of skeletal stability and function.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing indicates components are equivalent to predicate devices and capable of withstanding expected in vivo loading.

Technological Characteristics

Metallic bone fixation system consisting of plates, screws, and K-wires. Components are designed for small bone fixation. Materials are consistent with predicate metallic bone fixation appliances. No specific ASTM standards or software/algorithm components described.

Indications for Use

Indicated for fracture fixation, reconstruction, or arthrodeses of small bones (forefoot, midfoot, hindfoot, hand, carpal, metacarpal, phalanges, patella, radial/ulnar styloid, capitellum, radial head). Applicable to adolescents (12-21 years), adults, and patients with osteopenic bone.

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 6.5mm and 8.0mm Cannulated Screws (K060736)
• Synthes 2.4mm Cannulated Screw (K012945)
• Synthes 3.0mm Cannulated Screw (K962823)
• Synthes 3.0mm Headless Compression Screw (K050636)
• DePuy FRS Screw (K062352)
• Smith & Nephew K-Wires (Pre-amendment device)
• PERI-LOC Periarticular Locked Plating System VLP Plates/Screws (K071563)
• Smith & Nephew Locking Bone Plate System Peri-articular Plates (K033669)

Submission Summary (Full Text)

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

K090675 '/2

Summary of Safety and Effectiveness Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories

JUN - 4 2009

Date of Summary: March 11, 2009

Contact Person and Address Jahanvi Agnihotri Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 1 [phone]

Name of Device: Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories Common Name: Screws, Plates, and K-Wires

Device Classification Name and Reference: 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener – Class II; 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories – Class II Panel Code: Orthopaedics/87 HWC, HRS, HTY

### Device Description

Subject of this Traditional 510|k) premarket notification is Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories. The system is comprised of a variety of Cannulated Screws, Headless Cannulated Screws, QFX Screws, K-Wires, Cortex Screws, Locking Cortex Screws, Fully and Partially Threaded Osteopenia Screws, Locking Osteopenia Screws and a variety of VLP FOOT plates.

### Mechanical Testing Data

A review of the mechanical testing data indicates that the implant components of the VLP FOOT Plating, Screws and Accessories are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.

#### Intended Use

The Smith & Nephew VLP FOOT Plating System can be used in addlescent (12-18 years) and transitional adolescent 118-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot.

The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small joints; bunionectomies; scaphoid and other carpal bones, metacarpals, farsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The Smilh & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteolomies. Osteolomies, fusions and fractures of the phalanges, metacarpals and carpats of the hand. Pins and wires are indicated for pelvic, small and long bone fracture fixation.

### Substantial Equivalence Information

The substantial equivalence of the VLP FOOT Plating, Screws System and Accessories is based on its sinilarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below.

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

. .

.

# Summary of Safety and Effectiveness Schimary of Safety of Safety of Plating, Screw System and Accessories

።

| Description | 510(k) | Clearance Date |
|--------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew 6.5mm and 8.0mm Cannulated<br>Screws | K060736 | 4/18/06 |
| Synthes 2..4mm Cannulated Screw | K012945 | 12/03/2001 |
| Synthes 3.0mm Cannulated Screw | K962823 | 10/01/96 |
| Synthes 3.0mm Headless Compression Screw | K050636 | 4/21/05 |
| DePuy FRS Screw | K062352 | 10/19/2006 |
| Smith & Nephew K-Wires | Pre-amendment device | |
| PERI-LOC Periarticular Locked Plating System VLP<br>Plates/Screws | K071563 | 8/8/2007 |
| Smith & Nephew Locking Bone Plate System Peri-<br>articular Plates | K033669 | 12/10/2003 |

:

consister of the will and and on the

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

.

:

·

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Ms. Jahanvi Agnihotri 1450 East Brooks Road Memphis, Tennessee 38116

JUN - 4 2009

Re: K090675

Trade/Device Name: Smith & Nephew VLP FOOT Plating, Screw System and Accessories

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and

accessories Regulatory Class: II Product Code: HRS, HWC, HTY Dated: May 13. 2009 Received: May 14, 2009

Dear Ms. Agnihotri:

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 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. Jahanvi Agnihotri

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 Buettner

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

510(k) Number (if known):K090675

Device Name: Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories Indications for Use:

The VLP FOOT Plating, Screw System and Accessories is indicated for the following:

The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies, Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

Pins and wires are indicated for pelvic, small and long bone fracture fixation.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart Cl

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,

and Restorative Devices

Page 1 of 1.

510(k) Number K090675