TRIMAX NAIL SYSTEM

K964163 · Smith & Nephew Richards, Inc. · HSB · Dec 27, 1996 · Orthopedic

Device Facts

• Record ID: K964163
• Device Name: TRIMAX NAIL SYSTEM
• Applicant: Smith & Nephew Richards, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening/shortening; femur reconstruction following tumor resection and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures. Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures. Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants. The TriMax Nail System is intended to be removed upon fracture healing.

Device Story

TriMax Nail System consists of femoral nails and screws; used for intramedullary fixation of femoral fractures. Components implanted by orthopedic surgeons in clinical/OR settings to stabilize bone segments during healing. Device provides mechanical support for fracture reduction; intended for removal after bone union. Safety/effectiveness established via comparison to existing intramedullary fixation systems.

Clinical Evidence

Bench testing only. Mechanical testing performed to verify system capability to withstand normal in vivo loading without failure.

Technological Characteristics

Materials: Stainless steel. Components: Femoral nails and screws. Design: Intramedullary fixation system.

Indications for Use

Indicated for patients with femoral shaft fractures (comminuted, spiral, oblique, segmental), nonunions, malunions, bone length discrepancies, tumor resection, osteoporotic fractures, pathologic fractures, pseudoarthrosis, failed osteosynthesis, supracondylar fractures, and prophylactic stabilization. Specific indications for antegrade/recon nails include subtrochanteric fractures with lesser trochanter involvement and ipsilateral shaft/neck fractures. Retrograde nails indicated for supracondylar fractures, intra-articular extension, and fractures above total knee implants.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• ZMS Intramedullary Fixation System (Zimmer)
• Grosse & Kempf Locking Nail (Howmedica)
• Retrograde Femoral Nail (Biomet)
• Aim Titanium Supracondylar Nail (Ace)
• Alta Nail (Howmedica)
• Femoral Nail System (Synthes)

Submission Summary (Full Text)

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DEC-11-96 18:41 FROM: S&N CLINICAL AFFAIR
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# Summary of Safety and Effectiveness
## TriMax Nail System

### Substantial Equivalence Information

$K964163$

The TriMax Nail System is similar to the following systems:

1. ZMS Intramedullary Fixation System (Zimmer)
2. Grosse & Kempf Locking Nail (Howmedica)
3. Retrograde Femoral Nail (Biomet)
4. Aim Titanium Supracondylar Nail (Ace)
5. Alta Nail (Howmedica)
6. Femoral Nail System (Synthes)

DEC 27 1996

All of the devices listed above are similar in design to the TriMax Nail System. The safety and effectiveness of the TriMax Nail System is based on the long history of use of these devices in the market place.

### Device Description

The TriMax Nail System includes femoral nails and screws. All components are manufactured from stainless steel.

### Indications for Use

Femoral/recon antegrade nails and retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; bone lengthening/shortening; femur reconstruction following tumor resection and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed supracondylar fractures; and prophylactic nailing of impending pathologic fractures.

Additional indications for the femoral/recon antegrade include: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures.

Additional indications for retrograde nails include: severely comminuted supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. Also, fractures above total knee implants.

The TriMax Nail System is intended to be removed upon fracture healing.

### Mechanical Testing

Mechanical testing was performed on the system and all of the test results indicate that the TriMax Nail System is capable of withstanding normal in vivo loading without failure.

JG10016A/5