SMITH & NEPHEW CIRCULAR FIXATION SYSTEM

K093047 · Smith & Nephew, Inc. · KTT · Sep 27, 2010 · Orthopedic

Device Facts

• Record ID: K093047
• Device Name: SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Sep 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Circular Fixation System is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions. Components in the Smith & Nephew Circular Fixation System are for single use only.

Device Story

Multilateral external fixation system for long bone fracture fixation, joint fusion, and limb lengthening/deformity correction. System comprises aluminum rings, U-plates, adjustable struts, and stainless steel drill tip wires/accessories. Used in clinical settings by physicians. Optional web-based software assists physicians in calculating strut adjustments to create patient-specific schedules. Hardware provides mechanical stability for in vivo loading; software supports clinical decision-making by automating adjustment parameters. Benefits include stabilized bone healing and controlled distraction for deformity correction.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by bench testing, including cutting performance evaluation of drill tip wires, torque testing of pin connectors, wire pull-out force testing, and mechanical evaluation of struts. Software verification and validation performed per FDA guidance.

Technological Characteristics

Multilateral external fixation system. Materials: aluminum (rings, U-plates, struts), stainless steel (wires, connectors, bolts), polycarbonate (clips), PVC (caps). Connectivity: web-based software for adjustment scheduling. Software validation per FDA 2002 guidance.

Indications for Use

Indicated for patients requiring fracture fixation of long bones, joint fusion, limb lengthening, or correction of bony/soft tissue deformities/defects. Includes treatment for post-traumatic joint contracture, pseudoarthrosis, and infected fractures/nonunions. For prescription use only.

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

• Illizarov (Richards) External Fixation System (K870961)
• Illizarov External Fixation System (K962808)
• Taylor Spatial Frame (K970748)
• External Fixation System (K994143)
• Jet-X Bar System Clamps, Bar and Posts (K072212)
• VLP Foot Plating, Screw system and Accessories (K090675)

Submission Summary (Full Text)

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# We are smith&nephew

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | September 27, 2010 |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist<br>T [phone] F [phone] |
| Name of Device: | Smith & Nephew, Inc. Circular Fixation System |
| Common Name: | Multilateral Fixators and Accessories |
| Device Classification Name and<br>Reference: | 21 CFR 888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KTT, OSN |

### Device Description

Subject of this Traditional 510(k) premarket notification is the Smith & Nephew Circular Fixation System. The subject device is a multilateral external fixation system that is intended for fracture fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone. The Circular Fixation system can also be used with a software component that is designed to be used to assist the physician in adjusting the six struts by creating a patient adjustment schedule. Components of this premarket notification include the following:

- Full, half, 2/3 and foot rings manufactured from aluminum material. .
- . U-plates manufactured from aluminum material.
- Adjustable struts manufactured from aluminum material .
- . Drill tip wires manufactured from stainless steel material
- Accessory components such as rancho cubes, ring connectors, nuts, bolts and centering . sleeves manufactured from stainless steel material
- . Disc clips manufactured from polycarbonate material
- Half pin caps manufactured from PVC material �
- . Web-based software

The Circular Fixation System can also be used with other existing Smith and Nephew, Inc external fixation components.

#### Technological Characteristics

A review of the mechanical data indicates that the hardware components of the Circular Fixation System are capable of withstanding expected in vivo loading without failure. In addition, software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. The results of the testing indicate that the software will perform as intended. The following mechanical and software testing of the Circular Fixation System was performed:

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- . Cutting Performance Evaluation of Drill Tip Wires
- Evaluation of the maximum Tightening Torque of the Pin Connector Hinge and the Pin . Connector Post
- . Mechanical Evaluation of the Pin Connector Assembly
- . Evaluation of the Wire Pull-Out Force and Maximum Threading Torque of the Combo Wire Fixation Bolt
- . Mechanical Evaluation of the ControlFx Strut
- Software Installation Qualification Protocol ●
- Software Operational Qualification Protocol .
- . Software Performance Qualification Protocol

A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.

#### Intended Use

The Smith & Nephew Circular Fixation System is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions. Components in the Smith & Nephew Circular Fixation System are for single use only.

#### Substantial Equivalence Information

The substantial equivalence of the Circular Fixation System is based on its similarities in indications for use, design features, operational principles, and materials to the following predicate systems:

| Manufacturer | Description | Submission<br>Number | Clearance Date |
|----------------|---------------------------------------------------|----------------------|----------------|
| Smith & Nephew | Illizarov (Richards) External Fixation<br>System | K870961 | 03-19-1987 |
| Smith & Nephew | Illizarov External Fixation System | K962808 | 08-19-1996 |
| Smith & Nephew | Taylor Spatial Frame | K970748 | 05-09-1997 |
| Smith & Nephew | External Fixation System | K994143 | 02-18-2000 |
| Smith & Nephew | Jet-X Bar System Clamps, Bar and<br>Posts | K072212 | 03-07-2008 |
| Smith & Nephew | VLP Foot Plating, Screw system and<br>Accessories | K090675 | 06-04-2009 |

#### Conclusion

As previously noted, this Traditional Premarket Notification is being submitted to request clearance for the Circular Fixation system. Based on the similarities to the predicate components and a review of the mechanical and software testing performed, the devices are substantially equivalent to above predicate external fixation systems.

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers of the bird. The image is in black and white.

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

Smith and Nephew Endoscopy, Inc. % Ms. Shereen Myers Regulatory Affairs Specialist 1450 E Brooks Road -Memphis, TN 38116

SEP 2 7 2010

Re: K093047

Trade/Device Name: Smith & Nephew Circular Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: August 13, 2010 Received: August 13, 2010

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. Iisting 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. Shereen Myers

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as settonic device-related adverse events) (21 CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1580) html (2011) (1) ================================================ If you desire specific advice tor your device of to allothers/ucm II 1589.htm for a go to http://www.lda.gov/About/DA/CentersOft of CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) stocket natifiestion" (21C the Center for Devices and Radional by reference to premarket notification" (21 CFR Pat
note the regulation entitled, "Misbranding by reference to verder the MDP regulation ( note the regulation entitled, "Miscanding of reference wents under the MDR regulation (21 CFR Part 803), please go to

CFR Part 803), please go to Illip.77www.ida.gov.riednetrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may oftain other general information on your respected at its toll-free number [phone] or [phone] or at its Internet address

[phone] of [phone] er artistics of You/Industry/default.htm.

Sincerely yours,

Mark McMillan

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

K093047

SEP 2 7 2010

510(k) Number (if known): K093047

Device Name: Smith & Nephew Circular Fixation System

Indications for Use:

The Smith & Nephew Circular Fixation system is intended to be used for the following indications:

- Post-traumatic joint contracture which has resulted in loss of range of motion .
- Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
- Open and closed fracture fixation .
- Pseudoarthrosis of long bones .
- Limb lengthening by epiphyseal or metaphyseal distraction .
- Correction of bony or soft tissue deformities ●
- Correction of bony or soft tissue defects .
- Joint arthrodesis ●
- Infected fractures or nonunions .

Components in the Smith & Nephew Circular Fixation System are for single use only.

| Prescription Use | _X_ |
|-----------------------|-----|
| (Part 21 CFR 801.109) | |

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Srutu for mxm
(Division Sign Off)

Division of Surgical rthonedic and Restorative Devic

510(k) Number: K093047

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