# K182783: DePuy Synthes Trauma Orthopedic Nail Implants

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Dec 26, 2018 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981529 (1998). 35 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000972: Synthes (Usa) Trochanter Stabilization Plate for DHS, Synthes (Usa) (2000) Summary page 32.
- K002710: Modification to Synthes (Usa) Trochanter Stabilization Plate (TSB) for DHS (Line Extension), Synthes (Usa) (2000) Summary page 34.
- K002729: Synthes Proximal Humeral Nail, Synthes (Usa) (2000) Summary page 36.
- K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System, Synthes (Usa) (2001) Summary page 38.
- K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System, Synthes (Usa) (2004) Summary page 40.
- K040336: Synthes (Usa) Lateral Entry Femoral Nail System, Synthes (Usa) (2004) Summary page 42.
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 44.
- K042895: Synthes LCP Dynamic Helical Hip System, Additional Helix Blades, Synthes (Usa) (2004) Summary page 46.
- K051678: Synthes Hindfoot Arthrodesis Nail System, Synthes (Usa) (2005) Summary page 48.
- K052677: Synthes Universal Locking Trochanter Stabilization Plate (Ultsp), Synthes (Usa) (2005) Summary page 50.
- K070294: Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades, Synthes (Usa) (2007) Summary page 52.
- K070843: Synthes Adolescent Lateral Entry Femoral Nail System, Synthes (Usa) (2007) Summary page 54.
- K073402: Synthes Olecranon Osteotomy Nailing System, Synthes (Usa) (2008) Summary page 56.
- K092646: Synthes (Usa) Trochanteric Fixation Nail (TFN) Screw, Synthes (Usa) (2009) Summary page 58.
- K120083: Set Screw for TI Trochanteric Fixation Nail (TFN), Synthes USA (2012) Summary page 60.
- K131548: Synthes Trochanteric Fixation Nail - Advanced System, Synthes (USA) Products, LLC (2014) Summary page 62.
- K914371: Universal Femoral Nail, Synthes (Usa) (1992) Summary page 64.
- K914453: Universal Tibial Nail and Unreamed Tibial Nail, Synthes (Usa) (1992) Summary page 66.
- K923580: Synthes TI-6AI-7NB Unreamed Femoral Nail, Synthes (Usa) (1993) Summary page 68.
- K932330: TI-6AL-7NB Urtn, Synthes (Usa) (1996) Summary page 70.
- K932593: Access to Synthes TI-6A1-7NB Unreamed Femoral Nail, Synthes (Usa) (1994) Summary page 72.
- K933518: Synthes Unreamed Humeral Nail (Urhn), Synthes (Usa) (1994) Summary page 74.
- K954856: Cannulated Femoral Nail, Synthes (Usa) (1996) Summary page 76.
- K962047: Titanium Cannulated Tibial Nail (TI CTN), Synthes (Usa) (1996) Summary page 78.
- K970097: Proximal Femoral Nail (PFN) System, Synthes (Usa) (1997) Summary page 80.
- K970733: Synthes Titanium Diastal Femoral Nail (TI DFN) System, Synthes (Usa) (1997) Summary page 82.
- K971783: Synthes Elastic Intramedullary Nail (Ein) System, Synthes (Usa) (1997) Summary page 84.
- K992348: Synthes Spiral Blade for Humeral Nail (SBHN), Synthes (Usa) (1999) Summary page 86.

## Most influential descendants
- K253155: Fule Metallic Lockable Intramedullary Nail Systems (2026), 0 descendants of its own
- K201830: ANSER Clavicle Pin (2020), 0 descendants of its own

## Indications for use
The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system. The DePuy Synthes Trochanter Stabilization Plate (TSP) for the Dynamic Hip Screw System (DHS®) is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DHS® System. The DePuy Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus. The DePuy Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. The DePuy Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including: • supracondylar fractures, including those with intra-articular extension; • ipsilateral hip/shaft fractures; • ipsilateral femur/tibia fractures; • femoral fractures in multiple trauma patients; • fractures proximal to total knee arthroplasty; • fractures distal to a hip implant; • fractures in the morbidly obese; • fractures in osteoporotic bone, impending pathologic fractures; • malunions and nonunions The DePuy Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions. The DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. The DePuy Synthes LCP Dynamic Helical Hip System, Additional Helix Blades is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed. The DePuy Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis. The DePuy Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) for DHS or LCP DHHS is intented to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS) or the LCP Dynamic Helical Hip System (DHHS) side plates with four or more holes. The DePuy Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. The DePuy Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions in adolescent and small stature adult patients. The DePuy Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranlon osteotomies as well as simple fractures of the olecranon. As part of the DePuy Synthes Trochanteric Fixation Nail (TFN) System, the DePuy Synthes Trochanteric Fixation Nail (TFN) Screw is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. The DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions. The DePuy Synthes Trochanteric Fixation Nail - Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for: • Stable and unstable pertrochanteric fractures • Intertrochanteric fractures • Basal neck fractures • Combinations of pertrochanteric, intertrochanteric and basal neck fractures The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused for the following indications: • Subtrochanteric fractures • Pertrochanteric fractures associated with shaft fractures • Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions • Long Subtrochanteric fractures • Proximal or distal non-unions, malunions and revisions The DePuy Synthes Universal Femoral Nail is intended for use in stabilizing fractures of the femur. More specifically, the primary intended use is stable midshaft (diaphyseal) femoral fracture and hypertrophic pseudarthrosis (non-union) or unstable femoral fracture stabilization. The DePuy Synthes Universal Tibial Nail and the DePuy Synthes Unreamed Tibial Nail are intended for use in stabilizing fractures of the tibia. More specifically, the primary intended use of the Universal Tibial Nail is stable diaphyseal fractures or long or rotationally-unstable diaphyseal fractures, including rotationally unstable proximal and distal diaphyseal fractures. For the Unreamed Tibial Nail, the specific intended uses are Grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibias with small medullary canals; and certain pre- and postisthmic fractures. The DePuy Synthes TI-6AI-7NB Unreamed Femoral Nail is intended for use in stabilizing fractures of the femur. Specific Indications: Acute femoral diaphyseal fractures; post-isthmic femoral fractures; subtrochanteric femoral fractures. The DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) is intended to stabilize fractures of the tibia. Specifically, it is intended for grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibiae with small medullary canals; and certain pre- and post-isthmic fractures. The accessories are intended for use with the DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN), which is intended for use in stabilizing fractures of the femur. The Synthes Twisted Blade and 5.0 mm Shaft Screw, used with the Locking Sleeve and End Cap, are intended to transmit load between the bone and the URFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures (short, long, reverse oblique and comminuted). The DePuy Synthes Unreamed Humeral Nail (URHN) is intended to stabilize fractures of the humerus. It is specifically indicated for acute humeral shaft fractures, pathologic or impending pathologic fractures of the humeral shaft, and non- and mal unions of the humeral shaft. The DePuy Synthes Cannulated Femoral Nail (CFN) is intended to stabilize fractures of the femur. Specifically, the primary intended use is acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions and impending pathological fractures. The DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) is intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions. The DePuy Synthes Proximal Femoral Nail (PFN) System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. The DePuy Synthes Titanium Distal Femoral Nail (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 bane. The Ti DFN can be used in either reamed or non-reamed applications. The DePuy Synthes Elastic Intramedullary Nail (EIN) System is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate. The DePuy Synthes Spiral Blade for Humeral Nail (SBHN) is intended to stabilize fractures of the humerus.

Source page: https://510kreport.com/device/K182783
Methodology: https://510kreport.com/methodology