SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM

K970733 · Synthes (Usa) · HTY · Apr 2, 1997 · Orthopedic

Device Facts

• Record ID: K970733
• Device Name: SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HTY · Orthopedic
• Decision Date: Apr 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Ti DFN System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intra-articular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bone. The Ti DFN can be used in either reamed or non-reamed applications.

Device Story

Synthes Ti Distal Femoral Nail (DFN) system; cannulated and solid locking intramedullary fixation device; used for stabilization of distal femur fractures. System components: Transverse Locking Nails, 6.0 mm Ti Locking Screws, 4.9 mm Ti Locking Bolts, and Ti End Caps. Device implanted by surgeons in clinical/OR setting to provide mechanical stabilization of bone fractures. Benefits include fixation for complex fracture patterns, including osteoporotic bone and multiply injured patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use comparison to predicate devices.

Technological Characteristics

Cannulated and solid locking intramedullary fixation device; material: titanium alloy; diameters: 9 mm to 13 mm; lengths: 160 mm to 460 mm; locking components: 6.0 mm Ti Locking Screws, 4.9 mm Ti Locking Bolts, Ti End Caps.

Indications for Use

Indicated for stabilization of distal femur fractures, including supracondylar (intra/extra-articular), pathologic, mal-unions, non-unions, ipsilateral hip/shaft, ipsilateral femur/tibia, fractures proximal to total knee, fractures distal to total hip, multiply injured patients, morbidly obese patients, and osteoporotic bone.

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

• Richard's IMSC Five Nail
• Ace's Retrograde Trauma Nail

Submission Summary (Full Text)

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SYNTHES

K970733

Attachment IX:

Summary of Safety and Effectiveness Information [510(k) Summary]

Synthes (USA)
1690 Russell Road
Paoli, PA 19301

APR - 2 1997

[phone]
Contact: Sheri Musgnung
February 1997

Synthes Ti Distal Femoral Nail (DFN) is compared to Richard's IMSC Five Nail and Ace's Retrograde Trauma Nail.

The Synthes Ti DFN System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intra-articular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bone. The Ti DFN can be used in either reamed or non-reamed applications.

Richard's IMSC Five Nail is intended to stabilize fractures of the distal femur including supracondylar fractures of the distal femur, including those which extend into the articular surface, pathologic fractures of the distal femur, mal-unions of the distal femur, failed distal femoral osteosynthesis, and distal femur fractures in osteoporotic bone.

Ace's Retrograde Trauma Nail is intended to stabilize fractures of the distal femur including supracondylar fractures of the distal femur, including those with extra-articular comminution and/or intra-articular movement, malunions, non-unions, osteoporosis, osteotomies of the distal femur, failed osteosyntheses of the distal femur, fractures proximal to a total knee, and obese or multiple trauma patients with femoral shaft fractures.

Synthes Ti DFN System is a cannulated and solid locking intramedullary fixation device. The following components make up the DFN system: Transverse Locking Nails, 6.0 mm Ti Locking Screws, 4.9 mm Ti Locking Bolts, and Ti End Caps. Synthes Ti DFN System is manufactured from a titanium alloy.

Synthes Ti DFN has various locking options both proximally and distally. The Ti DFN are available in diameters ranging from 9 mm to 13 mm, and lengths ranging from 160 - 460 mm. The 6.0 mm Ti Locking Screws and 4.9 mm Ti Locking Bolts are used to lock the DFN into place. The Ti End Cap locks the distal 6.0 mm Ti Locking Screw to the Ti DFN.

Based on the information contained in this 510(k), the Ti DFN is at least equivalent to the Richard's IMSC Five Nail and Ace's Retrograde Trauma Nail.