(272 days)
The indications for use remain unchanged from the existing clearances.
TTC Fusion Nail:
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 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.
Small Bone Locked Plating System:
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.
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.
Spider Plate:
- 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
Reconstruction & Straight Plate:
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.
TiMax Medial Pilon Plate:
Pilon fractures: distal tibial intraarticular fractures, high medial malleolar fractures, low boot type rotational distal extraarticular shaft fractures.
TiMax Meta Plate:
Distal intra-articular tibia fractures; proximal tibia fractures; proximal and distal humerus fractures.
100 Degree Tubular Plate:
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.
Universal Reconstruction Plate:
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.
Anatomic Locked Plating System:
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.
Fracture and Fusion Plating System:
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.
LCL and Fusion Plating System:
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.
Proximal Tibia Locking Plating System:
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.
Sterile DVR:
Intended for fixation of fractures and osteotomies involving the distal radius.
Locking Anatomic and Composite Plating System:
For fixation of fractures, osteotomies and non-unions of the fibula, malleolus, metatarsals and metacarpais, olecranon, clavicle, scapula, distal humerus and humeral head, radius, ulna and distal tibia, particularly in osteopenic bone.
Anterolateral and Medial Locking Plating System:
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.
Large Fragment Locking Plating System (Locking Broad and Narrow):
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.
Small Fragment Locking Plating System:
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.
Fragment Plate System:
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.
Polyax Locked Plating System:
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.
Multidirectional Threaded Peg:
Intended for the fixation of fractures and osteotomies involving the distal radius.
Distal Volar Radius Anatomical Plate System:
Intended for the fixation of fractures and osteotomies involving the distal radius.
PERI II Knee Fracture System:
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.
Calcaneal Peri-Articular Plate:
Designed to assist the surgeon in the management of intra-articular fractures of the calcaneus, extra-articular fractures of the calcaneus.
TK2 Hip Screw System:
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.
Trochanteric Side Plate:
Internal fixation of hip fractures.
Supracondylar Plate:
Internal fixation of hip fractures.
Captured Hip Screw:
Internal fixation of hip fractures.
6.5mm Solid Cancellous Bone Screw:
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.
8.0mm Cannulated Cancellous Bone Screw:
Fracture fixation of long bones (femur, tibia, subcapital fracture of the hip, pelvic ring, acetabulum, foot and ankle and os calcis, olecranon).
Titanium Mini-Plating System:
For plating of maxillofacial fractures or for other small bone fractures (fracture fixation) as determined by the surgeon.
Cannulated Cortical Bone Screw:
Fracture fixation of long bones.
Cannulated Self-tapping Cancellous Bone Screw:
Fracture fixation of long bones.
Cannulated Self-tapping Cortical Bone Screw:
General orthopaedic conditions and fractures that would benefit from the use of cannulated self-tapping cortical bone screws.
Cancellous Bone Screw:
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.
Diaphyseal Plate:
Intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, fibula, particularly osteopenic bone.
Shoulder Fixation System:
Intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus.
Cannulated Bone Screw:
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.
Tibial Nail:
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.
Washer:
Intended to be used in conjunction with bone screws.
Trochanteric Nail:
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.
Universal Humeral Nail:
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.
Proximal Humeral Nail:
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.
Universal and Troch Entry Nail:
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 trohchanteric 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.
Rockwood Clavicle Pin:
Intended to be used to repair an acute fracture, malunion or non-union of the clavicle.
Small Bone Fixation System:
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.
Kirschner Wires & Steinmann Pins:
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.
This submission covers an update to the sterilization parameters of DePuy Orthopaedics' range of metallic internal fracture fixation devices manufactured from Titanium, Stainless Steel and Cobalt Chrome and include the following. No modifications have been made to the devices and they are identical to their predicates.
This is a 510(k) premarket notification for DePuy Orthopaedics' metallic internal fracture fixation devices. The submission concerns an update to the sterilization parameters for these devices, not a new device or a new performance claim for an existing device. Therefore, a clinical study proving device performance against acceptance criteria, as one would typically see for AI/ML devices or novel diagnostic tools, is not applicable to this submission.
The "acceptance criteria" here relate to the sterilization process, and the "study that proves the device meets the acceptance criteria" refers to the sterilization validation studies.
Here's a breakdown of the requested information in the context of this specific 510(k) submission:
Acceptance Criteria and Reported Device Performance (Sterilization)
| Acceptance Criteria Category | Specific Criteria (Inferred from context) | Reported Device Performance/Evidence |
|---|---|---|
| Sterilization Parameters | The updated sterilization parameters (temperature, time, pressure, etc.) must effectively sterilize the devices to a specified Sterility Assurance Level (SAL), typically 10⁻⁶, and be validated according to industry standards. This implicitly means the devices tolerate the new sterilization cycle without degradation of material properties or function. | "Based on testing per AAMI TIR 12 and ANSI/AAMI ST79, the recommended steam sterilization parameters have been updated." This statement confirms that validation studies were conducted specifically for sterilization using recognized consensus standards. AAMI TIR 12 ("Sterilization of health care products - Radiation - VDmax method - A guide for the establishing of minimum dose levels for radiation sterilization") and ANSI/AAMI ST79 ("Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities") are key standards for sterilization validation. |
| Substantial Equivalence | The updated devices and their updated sterilization parameters must be substantially equivalent to their predicate devices. This means there are no new questions of safety or effectiveness. The core design, material, and indications for use of the devices themselves have not changed. | "The products that are the subject of this submission are equivalent to the predicates. The technological characteristics are identical. Based on testing per AAMI TIR 12 and ANSI/AAMI ST79, the recommended steam sterilization parameters have been updated." This explicitly states equivalence and highlights that only the sterilization parameters were modified, not the device itself. |
Additional Requested Information (As applicable to this 510(k) type):
-
Sample size used for the test set and the data provenance:
- Test Set (for Sterilization Validation): For sterilization validation (as implied by AAMI TIR 12 and ANSI/AAMI ST79), samples of the actual devices (or representative product families) would be used. The typical approach involves biological indicator (BI) testing or bioburden testing. The specific quantitative sample size is not detailed in this 510(k) summary, as it's typically part of the detailed sterilization validation report, not the summary.
- Data Provenance: The testing would be conducted in a laboratory setting, likely at the manufacturer's facility or a contract sterilization validation lab. It is not patient data; it's laboratory-derived data related to the efficacy of the sterilization process on the devices.
- Retrospective or Prospective: This would be prospective validation testing, as the new sterilization parameters need to be verified to meet performance standards before implementation.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth (for Sterilization): The "ground truth" in this context is the successful achievement of a specified Sterility Assurance Level (SAL). This is established through established microbiological methods (e.g., negative growth in culture media after exposure to sterilized samples with biological indicators).
- Experts: The validation studies would be designed, executed, and interpreted by microbiologists, sterilization specialists, and regulatory affairs professionals, following recognized standards. Their specific number and qualifications are not detailed in the public 510(k) summary but are part of the internal Quality System documentation and validation reports.
-
Adjudication method for the test set:
- Adjudication: This concept typically applies to clinical data review or image interpretation. For sterilization validation, there isn't an "adjudication" method in the clinical sense. The results are objective (e.g., growth/no growth of biological indicators, measurement of sterilization parameters). Conformity is determined against predefined pass/fail criteria from the standards (AAMI TIR 12, ANSI/AAMI ST79).
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This submission is for metallic internal fracture fixation devices and an update to their sterilization parameters. It is not an AI/ML device, and therefore, an MRMC comparative effectiveness study is entirely irrelevant to this 510(k).
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As stated above, this is not an AI/ML device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth (for Sterilization): Microbiological sterility (absence of viable microorganisms) confirmed by standardized testing methods (e.g., biological indicator testing, bacteriostasis/fungistasis testing) according to AAMI TIR 12 and ANSI/AAMI ST79 guidelines.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device; therefore, there is no "training set."
-
How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device submission.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.