# K111663: Trauma Internal Fixation Systems

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 12, 2012 after 272 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962616 (1996). 96 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103408: Posterior Lateral Plates, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K101421: Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model 131218704-708; 851318704-708, 131218204, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K082300: Anatomic Locking Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K093474: Depuy Fracture and Fusion Plating System, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K091294: Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate,, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K090877: Proximal Tibia Locking Plate Standard and Large, 3.5MM Low Profile and Multidirectional Screws, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K090492: 1.5MM Small Locking Plate, 1.5MM Non-Locking and Locking Screws, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K083364: 2.5 MM Multidirectional Threaded Pegs, Models 131211110-131211130, 1.5 MM Locking Screws, Models 131220408-131220424, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K081546: Small Bone Locking Plating System, DePuy Orthopaedics, Inc. (2008) Summary page 1.
- K090374: Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10  2.5MM Threaded and Smooth Pegs, Model (S, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K083843: Locking Anatomic & Composite Plating System, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K072832: Anterolateral and Medial Locking Plating System, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K072423: 4.5MM Locking Broad & Narrow Compression Plates, 4.5MM & 5.5MM Cortical & Cancellous Locking Screws, Respectively., DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K072083: Small Fragment Locking Plating System, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K061748: Fragment Plate System, Hand Innovations, LLC (2006) Summary page 1.
- K060969: Polyax Locked Plating System, DePuy Orthopaedics, Inc. (2006) Summary page 1.
- K050932: Distal Volar Radius Anatomical Plate System, Hand Innovations, Inc. (2005) Summary page 1.
- K003235: PE.R.I. II Knee Fracture System, DePuy Orthopaedics, Inc. (2000) Summary page 2.
- K993465: Depuy Ace Calcaneal Peri-Articular Plate, Depuy, Inc. (2000) Summary page 2.
- K981775: Depuy Ace Timax Calcaneal Peri-Articular Plate, Depuy Ace Medical Co. (1998) Summary page 2.
- K990392: Depuy Ace Spider Plate, Depuy Ace Medical Co. (1999) Summary page 2.
- K990120: Modification of Depuy Ace Timax Medial Pilon Plate, Depuy Ace Medical Co. (1999) Summary page 2.
- K983853: Depuy Ace Timax Meta Plate, Depuy Ace Medical Co. (1998)
- K972629: Depuy AE TK2 Hip Screw System, Depuy, Inc. (1997) Summary page 2.
- K970503: Depuy Ace Trochanteric Side Plate, Depuy Ace Medical Co. (1997) Summary page 2.
- K950618: Ace Supracondylar Plate, Ace Medical Co. (1995) Summary page 2.
- K813554: Ace/Kyle Captured Hip Screw, Ace Orthopedic Manufacturing Co. (1982) Summary page 2.
- K930592: Ace Universal Reconstruction Plate, Ace Medical Co. (1993) Summary page 2.
- K920738: Ace 100 Degrees Tubular Plate, Ace Orthopedic Manufacturing Co. (1992) Summary page 2.
- K905774: Thackray Titanium Mini-Plating System, Depuy, Inc. (1991) Summary page 2.
- K905595: Ace Reconstructive Plate, Ace Medical Co. (1991) Summary page 2.
- K060864: Multidirectional Threaded Peg, Hand Innovations, LLC (2006) Summary page 2.
- K954485: 6.5MM Solid Cancellous Bone Screw, Ace Medical Co. (1995) Summary page 2.
- K926047: Ace 8.0MM Cannulated Cancellous Bone Screw, Ace Orthopedic Manufacturing Co. (1993) Summary page 2.
- K903811: Ace Cannulated Cortical Bone Screw, Ace Medical Co. (1990) Summary page 2.
- K903810: Ace Cannulated Self Tapping Cancellous Bone Screw, Ace Medical Co. (1990) Summary page 2.
- K874670: Ace Cannulated Self-Tapping Cortical Bone Screw, Buckman Co., Inc. (1987) Summary page 2.
- K872859: Ace Cancellous Bone Screw, Ace Medical Co. (1987) Summary page 2.
- K895107: Ace Orthopaedic Washers, Buckman Co., Inc. (1989) Summary page 2.
- K042325: Trochanteric Nail System, DePuy Orthopaedics, Inc. (2004) Summary page 2.
- K033878: Ace Antegrade Retrograde Humeral Nail System, Depuy Ace (2004) Summary page 2.
- K033806: Ace Proximal Humeral Nail System, Depuy Ace (2004) Summary page 2.
- K033329: Depuy Ace Universal and Troch Entry Femoral Nail Systems, Depuy, Inc. (2003) Summary page 2.
- K032097: Depuy Ace Versanail Tibial Nail, DePuy Orthopaedics, Inc. (2003) Summary page 2.
- K023115: Ace Versanail, DePuy Orthopaedics, Inc. (2002) Summary page 2.
- K003797: Ace Aim TTC Fusion Nail, DePuy Orthopaedics, Inc. (2000) Summary page 2.
- K060290: Shoulder Fixation System, Hand Innovations, LLC (2006) Summary page 2.
- K060294: Diaphyseal Plate, Hand Innovations, LLC (2006) Summary page 2.
- K893512: Depuy Cannulated Bone Screw, Depuy, Inc. (1989) Summary page 2.
- K103001: Rockwood Clavicle Pins, DePuy Orthopaedics, Inc. (2011) Summary page 2.
- K041157: Modification to Small Bone Fixation System, Hand Innovations, Inc. (2004) Summary page 2.
- K960385: Sterile Kirschner Wires and Steinmann Pins, Depuy, Inc. (1996) Summary page 2.

## Most influential descendants
- K243761: A.L.P.S. Small Fragment Plating System (2025), 0 descendants of its own

## Recalls of this device
- Feb 14, 2022 · Class II · Z-0811-2022: Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and
- Dec 20, 2017 · Class II · Z-1233-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1226-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1227-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1231-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1234-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1229-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1225-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1228-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1230-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1232-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Dec 20, 2017 · Class II · Z-1235-2018: Zimmer Biomet is conducting a medical device recall for the ACE Trochanteric Nail (ATN) system after a Device Performance Review (DPR) failed clinical analysis for survivorship pursuant to the accepta
- Oct 25, 2017 · Class II · Z-1306-2018: The drill guides were manufactured with the incorrect color anodization.
- Apr 1, 2016 · Class II · Z-1817-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non
- Nov 20, 2015 · Class II · Z-0450-2016: These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, sof
- Jun 4, 2015 · Class II · Z-2046-2015: The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the pl
- Jun 4, 2015 · Class II · Z-2058-2015: Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.

## Indications for use
Intended for use in intramedullary fixation of supracondylar fractures of the femur, including those with severe comminution and intraarticular involvement, osteoporosis, nonunions, malunions, pathologic and fractures proximal to total knee arthroplasty or prosthesis. The TTC Fusion Nail is also indicated for use in tibiotalocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement, absent talus (tibio calcaneal arthrodesis); post traumatic/primary arthrosis involving both ankle and subtalar joints; a rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total arthroplasty. Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 -21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients. Intended for use in tibiocalcaneal fusions and treatment of trauma to the hindfoot and distal tibia. Indications include: revision after failed ankle arthrodesis with subtalar involvement; absent talus (tibiocalcaneal arthrodesis); post traumatic or primary arthrosis involving both ankle and subtalar joints; rheumatoid hindfoot; avascular necrosis of the talus; previously infected arthrosis, second degree; failed total ankle arthroplasty. Indications also include non-union ankle arthrodesis; osteoarthritis; post-traumatic and degenerative arthritis; neuroarthropathy or neuropathic ankle deformity; neuromuscular disease with severe deformity and Charcot foot. * Fixation of metaphyseal fractures of the distal tibia * Proximal metaphyseal tibial fractures * Calcaneus fractures * Proximal humeral head/shaft fractures * Distal femur fracture - comminuted shaft fractures * Fixation of soft tissue, such as tendon and ligaments, to bone Small bone plates (3.5mm): For intra-articular distal tibial fractures and those of the humeral head; for fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon and distal humerus; for application to the palmar surface of the distal radius and fractures of the olecranon and distal tibia; for application to the dorsum of the distal radius; fractures of the calcaneus; fractures of the radius and ulna; for pelvic and acetabular reconstructive surgery Large bone plates (4.5, 6.5mm): For use on the tibia, femur and humerus; for use on the anterior aspect of the distal tibia; for use as a tension band on the proximal humerus and as a buttress on the medial tibial plateau; for use as a buttress on the lateral tibial plateau; for use on fractures of the pelvis and acetabulum; for fractures of the distal humerus; for use as a tension band plate on the radius, ulna and fibula Pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot, type rotational distal extraarticular shaft fractures. Distal intra-articular tibia fractures; proximal tibia fractures; proximal and distal humerus fractures Fractures of the fibula, lateral malleolus, metatarsals and metacarpals, olecranon, distal humerus and humeral head; application to the dorsum of the distal radius; fractures of the radius and ulna; intra-articular distal tibial fractures The 3.5mm plate may be used for fractures of the clavicle, scapula, distal humerus, acetabulum and pelvis. The 4.5mm plate is intended for use in the following types of fractures: pelvic fractures and acetabular fractures. For fixation of fractures, fusions, osteotomies and non-unions of the clavicle, humerus, radius, ulna, olecranon, metacarpal, metatarsal, malleolus, tibia, fibula, particularly in osteopenic bone Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients. Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients. Intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures. For stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone. Intended for fixation of fractures and osteotomies involving the distal radius For fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpals, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone. The Medial Locking Plate is indicated for pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot type rotational distal extraarticular shaft fractures. The Anterolateral Locking Plates are indicated for distal intraarticular tibia fractures, proximal tibia fractures and proximal and distal humerus fractures. Fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation and stabilization of non-unions, malunions and osteotomies. Intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone Intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton. Intended for use in cases requiring stabilization of malunions, non-unions, and osteotomies of the distal femur and proximal tibia and Open Reduction Internal Fixation (ORIF) repair of closed and open fractures of the distal femur and proximal tibia including, but not limited to the following: periarticular fractures, such as simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression fractures with associated shaft fractures, and periprosthetic fractures. Intended for the fixation of fractures and osteotomies involving the distal radius Intended for the fixation of fractures and osteotomies involving the distal radius Intended for use in fracture fixation cases requiring open reduction internal fixation (ORIF) for closed and open fractures of the distal femur and proximal tibia including repair of non-unions, malunions and fractures including but not limited to simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures Designed to assist the surgeon in the management of intra-articular fractures of the calcaneus, extra-articular fractures of the calcaneus Indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgment surrounding each patient's particular situation. Internal fixation of hip fractures Internal fixation of hip fractures Internal fixation of hip fractures Indications for use of this device shall include fixation of the pelvis and of the long bones, including the femur, tibia, ulna, radius, humerus and fibula. Fracture fixation of long bones (femur, tibia, subcapital fracture of the hip, pelvic ring, acetabulum, foot and ankle and os calcis, olecranon) For plating of maxillofacial fractures or for other small bone fractures (fracture fixation) as determined by the surgeon Fracture fixation of long bones Fracture fixation of long bones General orthopaedic conditions and fractures that would benefit from the use of cannulated self-tapping cortical bone screws Internal fixation of hip fractures and for additional orthopaedic indications such as condylar fractures of the distal femur and/or selected fractures of the tibial plateau. Intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus Intended for use over a guide pin for fracture fixation in cancellous bone. The cannulated screw is intended to be inserted into pre-drilled bone. Intended for bone fixation in the management of fracture and reconstructive surgeries. Non-weight bearing bone fixation is indicated in the following conditions: " Transverse, oblique, spiral, segmental and comminuted fractures; * Fractures with bone loss and bone transport; * Open fractures, pathologic fractures; * Corrective osteotomies; * Pseudarthrosis of the tibial shaft; * Nonunions, malunions, metaphyseal and epiphyseal fractures. Intended to be used in conjunction with bone screws Intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures. The Trochanteric Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions and malunions and revision procedures. Indicated for open and closed fracture patterns, humeral shaft fractures, fractures of the proximal and distal metaphysis, comminuted fractures of the humerus with small medullary canals, fracture non-unions and mal-unions, pathological fractures, floating elbow. Intended for the fixation of proximal humeral fractures. These implants are intended as a guide to normal healing and are not intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Intended to treat proximal, middle and distal third fractures, severely comminuted shaft fractures extending beyond the isthmus, spiral, long oblique and segmental fractures, non-unions and malunions, lengthening of the bone, fractures with bone loss, bi-lateral fractures, pseudoarthrosis of the femoral shaft, supracondylar fractures, subtrochanteric fractures, with or without involvement of lesser trochanter, subtrochanteric/intertrochanteric combination fractures, ipsilateral femoral shaft and neck fractures, stable and unstable proximal fractures of the femur, including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, pertrochanteric features associated with shaft fractures, pathologic fractures in osteoporotic bone of the trochanteric and diaphyseal areas, proximal or distal non-unions and malunions, leg length discrepancies secondary to femoral inequality, femur reconstruction following tumor resection, stable femoral fractures without necessity for interlocking, long subtrochanteric fractures, and revision procedures involving the replacement of implanted hardware. In addition to the above indications, the Universal NAIL, when used in the retrograde mode, is also indicated for treatment of femoral shaft fractures in obese or multiple trauma patients and supracondylar fractures, including those with severe, extra-articular comminution and/or intra-articular involvement, osteoporosis, non-unions, malunions, pathologic fractures, and those proximal to total knee prosthesis. Intended to be used to repair an acute fracture, malunion or non-union of the clavicle. For the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot. Fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K111663
Methodology: https://510kreport.com/methodology