# K122170: Smith & Nephew, Inc. Intramedullary Nail System Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 19, 2012 after 88 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981529 (1998). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K811002: Ender Pins, Richard'S Medical Equip., Inc. (1981) Summary page 1.
- K964163: Trimax Nail System, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K974409: Friedl Gliding Nail System, Plus Orthopedics (1998) Summary page 1.
- K981529: Titanium Intramedullary Nail, Titanium Locking Screw, Smith & Nephew, Inc. (1998) Summary page 1.
- K020240: Slim Gliding Nail System, Plus Orthopedics (2002) Summary page 1.
- K032548: IP-XS Compression Nail System, Plus Orthopedics (2003) Summary page 1.
- K032722: Trigen Straight Humeral Nail System, Smith & Nephew, Inc. (2003) Summary page 1.
- K033763: Modification to Slim Gliding Nail System, Plus Orthopedics (2003) Summary page 1.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 1.
- K040462: Trigen Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2004) Summary page 1.
- K040656: Modification to Smith & Nephew Intramedullary Hip Screw, Smith & Nephew, Inc. (2004) Summary page 1.
- K040929: Trigen Adolescent Tan, Smith & Nephew, Inc. (2004) Summary page 1.
- K043052: Trigen Hindfoot Fusion Nail, Smith & Nephew, Inc. (2004) Summary page 1.
- K050938: Knee Fusion Nail, Smith & Nephew, Inc. (2005) Summary page 1.
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails, Smith & Nephew, Inc. (2006) Summary page 1.
- K061783: Knee Fusion Nail, Smith & Nephew, Inc. (2006) Summary page 1.
- K092748: Sureshot Tan Nails and Accessories, Smith & Nephew, Inc. (2010) Summary page 1.
- K111025: Trigen Low Profile Bone Screw, Smith & Nephew, Inc. (2011) Summary page 1.

## Recalls of this device
- Oct 7, 2019 · Class II · Z-0351-2020: LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compr

## Indications for use
Smith & Nephew Trigen Adolescent TAN Nail System and Trigen 1300 TAN Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew Trigen Adolescent TAN Nail System and the Smith & Nephew Trigen 1300 TAN Nail System and their cleared indications for use. Indications for interlocking intramedullary nails include: * Simple long bone fractures * Severely comminuted, spiral, large oblique and segmental fractures * Nonunions and malunions * Poly trauma and multiple fractures * Prophylactic nailing of impending pathologic fractures * Reconstruction following tumor resection and grafting * Supracondylar fractures * Bone lengthening and shortening * Fractures that occur in and between the proximal and distal third of the long bones being treated In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability are indicated for the following: * Subtrochanteric fractures with lesser trochanteric involvement * Ipsilateral femoral shaft/neck fractures * Intertrochanteric fractures Smith & Nephew Trigen Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Trigen System and its cleared indications for use. TRIGEN 0 Humeral Nail System is indicated for: * Proximal and/or diaphyseal fractures of the humerus * Nonunions * Malalignments * Pathological humeral fractures * Impending pathological fractures Smith & Nephew Trigen InterTAN Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Trigen InterTAN Nail System and its cleared indications for use. TRIGEN InterTAN Nails are indicated for: * Simple long bone fractures * Severely comminuted spiral, long oblique, and segmental shaft * Nonunions and malunions * Poly trauma and multiple fractures * Prophylactic nailing of impending pathologic fractures * Reconstruction, following tumor resection and grafting * Bone lengthening and shortening * Subtrochanteric fractures * Ipsilateral femoral shaft/neck fractures * Intertrochanteric fractures * Intracapsular fractures Smith & Nephew Intramedullary Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Intramedullary Nail Systems and their cleared indications for use. The Short Knee Nail, REVISION 0 Nail and Hindfoot Fusion Nail (HFN) are indicated for: * Degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot * Tibiocalcaneal arthrodesis * Combined arthrodesis of the ankle and sub-talar joints * Avascular necrosis of the ankle and sub-talar joints * Failed total ankle replacement with sub-talar intrusion * Failed ankle arthrodesis with insufficient talar body * Rheumatoid arthritis * Severe deformity secondary to untreated talipes eguinovarus or neuromuscular disease * Severe pilon fractures with trauma to the subtalar joint Smith & Nephew SURESHOT TAN Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew SURESHOT TAN Nail Systems and their cleared indications for use. SURESHOT TAN Nails are indicated for: * Fractures of the femur including: o simple long bone fractures o severely comminuted, spiral, large oblique and segmental fractures * Non unions and malunions * Poly trauma and multiple fractures * Prophylactic nailing of impending pathologic fractures * Reconstruction, following tumor resection and grafting * Supracondylar fractures * Bone lengthening and shortening * Fixation of fractures that occur in and between the proximal third and distal fourth of the femur In addition, SURESHOT TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: * Subtrochanteric fractures; * Intertrochanteric fractures; * Ipsilateral femoral shaft/neck fractures; * Intracapsular fractures. Smith & Nephew Intramedullary Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Intramedullary Hip Screw Systems and their cleared indications for use. Intramedullary Hip Screws are indicated for: * Intracapsular fractures of the femoral neck; * Trochanteric or subtrochanteric fractures; * Osteotomies for patients with diseases or deformities of the hip; * Hip arthrodesis; * Supracondylar fractures and distal femoral fractures using a supracondylar plate; * Ipsilateral femoral shaft/neck fractures; * Intertrochanteric fractures; * Femoral neck fractures; * Subrapital fractures; * Comminuted neck and shaft fractures; * Femur reconstruction following tumor resection; * Leg length discrepancies secondary to femoral inequality; * Prophylactic nailing of impending pathologic fractures. Smith & Nephew Ender Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Ender Nail Systems and their cleared indications for use. ENDER Nails are indicated for: * Fracture of the neck, trochanteric, and subtrochanteric region of the femur; * Distal femoral fractures with a distal fragment 10cm or longer * Tibial shaft fractures * Proximal humeral fractures Smith & Nephew TriMax Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew TriMax Nail Systems and their cleared indications for use. Femoral/Recon antegrade nails and retrograde nails are indicated for: * Shaft fractures including severely comminuted, spiral, large oblique and segmental fractures * Non-unions and malunions * Bone lengthening/shortening * Severely comminuted shaft fractures * Pathologic fractures, pseudloarthrosis, failed osteosynthesis * Closed supracondylar fractures * Prophylactic nailing of impeding 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 * Fractures above total knee implants The TriMax Nail System is intended to be removed upon fracture healing. Indications for interlocking intramedullary nails include: * Simple long bone fractures * Severely comminuted, spiral, large oblique and segmental fractures * Nonunions and malunions * Poly trauma and multiple fractures * Prophylactic nailing of impending pathologic fractures * Reconstruction following tumor resection and grafting * Supracondylar fractures * Bone lengthening and shortening * Fractures that occur in and between the proximal and distal third of the long bones being treated In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: * Subtrochanteric fractures * Intertrochanteric fractures * Ipsilateral femoral shaft/neck fractures In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for: * Comminuted supracondylar fractures with or without intra-articular extension * Fractures that require opening the knee joint to stabilize the femoral condylar segment * Fractures above total knee implants (peri-prosthetic fractures) Smith & Nephew Knee Fusion Nail Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Knee Fusion Nails and their cleared indications for use. Knee Fusion Nails are indicated for: * Intramedullary Knee Arthrodesis Smith & Nephew IP-XS Compression Nail System Instruments are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew IP-XS Compression Nail System and its cleared indications for use. The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the: * Alignment, stabilization, and fixation of fractures caused by disease or trauma * The fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity * Arthrodesis Smith & Nephew SLIM (Friedi) Gliding Nail Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew SLIM (Friedi) Gliding Nails and their cleared indications for use. The SLIM (Friedl) Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in: * Petrochanteric femoral fractures * Subtrochanteric femoral fractures * Lateral femoral neck fractures Internal fixation with the SLIM (Friedl) Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM (Friedl) Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur. Smith & Nephew TriGen Low Profile Bone Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew TriGen Low Profile Bone Screws and their cleared indications for use. The TRIGEN TM Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGEN TM) Titanium Nail System. The TRIGEN TM Low Profile Bone Screw therefore has the following indications: Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures. In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic fractures). The TRIGEN TM InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening. SURESHOT TM TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur. In addition, SURESHOT TM TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

Source page: https://510kreport.com/device/K122170
Methodology: https://510kreport.com/methodology