TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM

K970748 · Smith & Nephew, Inc., Orthopaedic Div. · KTT · May 9, 1997 · Orthopedic

Device Facts

• Record ID: K970748
• Device Name: TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: KTT · Orthopedic
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Taylor Spatial Frame (TSF) external fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The TSF is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna. The TSF is intended for fixation of fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.

Device Story

External fixation system for long bone stabilization/correction; consists of full/partial rings connected by six telescopic struts with articulating ball joints; utilizes Ilizarov system pins, wires, and washers for limb attachment. Surgeon-operated; used in clinical/surgical settings. Software program assists surgeon by calculating strut adjustments, replacing manual calculations for frame configuration. Output guides mechanical adjustment of struts to achieve desired bone alignment/lengthening. Benefits include precise control over complex deformity correction and limb lengthening through adjustable frame geometry.

Clinical Evidence

No clinical data provided; device relies on mechanical design and established orthopedic principles for fracture fixation and deformity correction.

Technological Characteristics

Circular external fixator; components include rings, six telescopic struts, articulating ball joints, pins, wires, and washers. Compatible with Ilizarov system hardware. Single-use. Software-assisted calculation for strut adjustment.

Indications for Use

Indicated for patients requiring open/closed fracture fixation, pseudoarthrosis/nonunion treatment, limb lengthening, or correction of bony/soft tissue deformities/defects in long bones (tibia, fibula, femur, humerus, radius, ulna). Contraindicated for use in the spine.

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.

Reference Devices

• Ilizarov External Fixator System

Submission Summary (Full Text)

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Exhibit 14
MAY - 9 1997
K970748

# Summary of Safety and Effectiveness

Smith & Nephew Inc. Orthopaedic Division

## Taylor Spatial Frame External Fixation System

The Taylor Spatial Frame (TSF) external fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The TSF is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

| Fixator Construct Classification: | Long Bone / Limb Lengthening |
| --- | --- |
| Frame Limb Access Classification: | Circular |
| Frame Pin Configuration Classification: | Multi-plane |

The TSF is intended for fixation of fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.

The TSF is not intended for use in the spine, and it does not claim dynamization benefits or MRI compatibility.

The TSF consists of full or partial rings coupled by six telescopic struts which terminate at each end by articulating ball joints. The components of the Taylor Spatial Frame External Fixator are intended to be used with pins, wires and washers of the Ilizarov External Fixator System. The half-pins, wires and washers of the Ilizarov system are inserted into the affected limb. The wires are tensioned and attached to the TSF ring of the TSF frame using an Ilizarov fixation bolt. Half-pin fixation is occasionally used instead of wires. An adjustable half-pin clamp allows for the orientation of the insertion of the half-pins or femoral screws. A universal joint may be used in cases where movement is necessary. Rancho cubes are available for half-pins combined with TSF rings.

The devices are for single use. Cementless or cement fixation is not applicable to this device. These devices have not been submitted to the FDA for identical or different intended uses.

A software program is included with the surgical technique. To template or guide the device, a software program is used to assist the surgeon and is equivalent to performing manual calculations to obtain the numbers necessary to adjust the 6 telescopic struts and apply the TSF external fixation device.

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