(67 days)
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Not Found
No
The device description mentions a software program used for calculations equivalent to manual methods, with no indication of AI or ML capabilities.
Yes
The device is used for medical purposes such as fracture fixation, limb lengthening, and correction of deformities.
No
Explanation: The device description states its purpose is for "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." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly outlines a physical external fixator system consisting of rings, struts, pins, wires, and other hardware components. While a software program is mentioned, it is described as an accessory used to assist the surgeon in calculating adjustments for the physical device, not as the primary medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The Taylor Spatial Frame (TSF) is an external fixator used for the mechanical stabilization and manipulation of bones. It is applied directly to the patient's limb.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device's function is entirely external and mechanical.
Therefore, the TSF falls under the category of a surgical device or orthopedic implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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 Tavlor Special 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 Ilization bolt. Half-pin fixation is occasionally used instead of wires. An adjustable half-pin clamp allows for 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
All long bones including: tibia, fibula, femur, humerus, radius and ulna. Intracapsular, intertrochanteric, supracondylar, or condylar fractures of long bones.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
Exhibit 14
MAY - 9 1997
970748
Summary of Safety and Effectiveness
Smith & Nephew Inc. Orthopaedic Division
Tavlor 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 Tavlor Special 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 Ilization bolt. Half-pin fixation is occasionally used instead of wires. An adjustable half-pin clamp allows for 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.