Search Results

Smith & Nephew Plate and Screw Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plate and Screw Systems and their cleared Indications for Use.

PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories:
Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.
The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories are indicated for:

• fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with the medial cortex instability
• proximal femur fractures combined with ipsilateral shaft fractures
• pathological fractures of the proximal femur including metastatic fractures
• proximal femur osteotomies
• fixation of fractures in osteopenic bone
• fixation of nonunions and malunions
• basi/transcervical femoral neck fractures
• subcapital femoral neck fractures
• subtrochanteric femur fractures.
  In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for:
• fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Smith & Nephew VLP FOOT Plating System, Screw System and Accessories:
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.
The Smith & Nephew VLP FOOT Plating System is indicated for:

• the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
  The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for:
• fixation of interarticular and extra-articular fractures and non-unions of small bones and small bone fragments;
• arthrodesis of small joints;
• bunionectomies and osteotomies;
• scraphold and other carpal bones;
• metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
  The Smith & Nephew 2.0mm QFX Screw is indicated for:
• osteotomies of the lesser metatarsals, such as Weil osteotomies, osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
  Smith & Nephew Accessories, such as pins and wires, are indicated for:
• pelvic, small and long bone fracture fixation.

Smith & Nephew InterTAN CHS Limited Collapse Set Screw:
Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.
InterTAN CHS Limited Collapse Set Screw is indicated for:

• Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
• Intertrochanteric fractures.
• Stable and unstable fractuers of the proximal femur in which medial cortex stability can be restored.
• Hip osteotomy

PERI-LOC Periarticular Locked Plating System- VLP Locking Bone Plates and Locking/Non-Locking Bone Screws:
Smith & Nephew VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use.
PERI-LOC contoured VLP Plates and Screws are indicated for:

• partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia and for fracture fixation of the fibula
  PERI-LOC VLP One-Third Tubular Locking Plates are indicated for:
• fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws:
Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:

• fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones;
• treatment of the calcaneal
• hip arthrodesis
• provisional bone fixation.

Smith & Nephew Bone Plate System:
Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Plate Systems and their cleared indications for use.
Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for:

• pelvic fracture fixation
• small bone fracture fixation
• long bone fracture fixation.

Titanium Classic Compression Hip Screw System:
Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.
The Titanium Classic Compression Hip Screw System is indicated for:

• Pelvic Radius Plate- general fractures of the pelvis and acetabulum
• Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement
• One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, metatarsals, olecranon, and distal ulna
• Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and ulna
• Titanium Cortical Bone Screw- small and long bone fracture fixation

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Plate and Screw Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plates and Screws and their cleared Indications for Use. Smith & Nephew Plate and Screw Systems Instruments can be organized into instrument families which are categorized as follows: Templates, Reamers, Handles, Bases, Pins, Taps, Drill Guides, Insertion or Removal, and Other Guides.

This document describes a 510(k) premarket notification for "Plate and Screw Instruments" by Smith & Nephew, Inc. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document pertains to orthopedic surgical instrumentation, which are physical tools (templates, reamers, handles, pins, taps, drill guides, etc.) used to assist in the implantation of bone plates and screws. These are accessory devices to existing cleared bone fixation systems.

The submission is for substantial equivalence to previously cleared predicate devices, not for a novel device requiring performance studies or clinical trials to establish new safety and effectiveness claims based on specific acceptance criteria. The basis for substantial equivalence is listed as:

• Sharing the same raw materials
• Manufactured through the same processes
• Utilizing the same sterilization procedures
• Having a similar nature of body contact
• Similar in design and function to competing surgical instrumentation on the market.

Therefore, the requested information points, which are typically relevant for AI/ML device submissions involving performance benchmarks and clinical studies, are not applicable to this document. There are no acceptance criteria related to a model's performance, no data sets (training or test), no ground truth establishment, and no mention of human-in-the-loop studies or standalone algorithm performance.

Ask a specific question about this device

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.

The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• avascular necrosis of femoral condyle
• post traumatic loss of joint configuration
• primary implantation failure.

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Medacta Bone Screws have a thread diameter of 6.5 mm. The Medacta Bone Screws come in six lengths from 20 mm to 45 mm in increments of 5 mm. The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy.

The provided K091069 510(k) summary describes a traditional 510(k) submission for the Medacta Bone Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material, design, and performance testing against recognized standards, rather than a clinical study evaluating diagnostic performance using AI.

Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Performance testing," which was conducted in accordance with ASTM F543-07 and FDA guidance documents. This testing demonstrated conformance to these standards.

Information on AI-Related Aspects (Not Applicable to this 510(k)):

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This was not an AI-based diagnostic device. The "test set" would refer to the physical bone screws tested per ASTM F543-07, not a dataset.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There was no "ground truth" in the clinical sense for this type of device submission. Performance was based on mechanical testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for bone screws is their mechanical properties meeting established engineering standards.
• The sample size for the training set: Not applicable. This was not an AI device, so there was no training set.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The TC-Plus Primary Knee is intended as a cemented surface replacement in treating patients who are candidates for primary total knee arthroplasty or revision knee arthroplasy. It is indicated for degenerative, post traumatic or rheumatoid arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, in particular in the event of patello-femoral erosion, functional disability or an earlier patellectomy; moderate varus, valgus or flexure deformity and to correct earlier unsuccessful attempts at surgery.

Subject of this premarket notification is the TC-PLUS Primary Knee System. The TC-PLUS Primary Knee System is a tricompartmental total knee prosthesis comprised of femoral, patellar, and tibial components with an ultra-high molecular weight polyethylene articular insert. The femoral and tibial baseplate components are offered with or without a plasma-sprayed titanium coating.

The TC-PLUS Primary Knee System is comprised of existing implant components of the previously-cleared VKS Knee System and the TC-PLUS Solution Knee System. The femoral components are the previouslycleared TC-PLUS Solution femoral components available with (K011258) or without (K000666) a titanium plasma-spray coating. The articular insert and tibial baseplate components in the TC-PLUS Primary Knee System are identical to those of the VKS Knee System (K022204). The titanium plasma-sprayed tibial baseplates in the system feature holes to accept cancellous bone screws' for supplemental fixation. The patellar components of the subject knee system are the existing patellar implants cleared as part of K000666.

There are no new implant designs included in this premarket notification other than the addition of a size 12 tibial baseplate and size 20mm thick articular inserts. This 510(k) seeks to combine two existing knee systems into one and to also harmonize the sizing for both systems.

This document is a 510(k) premarket notification for the Smith & Nephew TC-Plus Primary Knee System. This type of submission relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than conducting new clinical studies with defined acceptance criteria and performance outcomes. Therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this document.

Here's why the provided text does not contain the requested information:

• Substantial Equivalence: The document explicitly states that the submission aims to demonstrate "Substantial Equivalence Information" to "previously cleared devices." This regulatory pathway for medical devices (510(k)) focuses on showing that a new device is as safe and effective as another legally marketed device, rather than requiring new clinical trials that establish independent performance criteria.
• Device Description: The core of the submission is combining existing, cleared components from two previous knee systems (VKS Knee System and TC-PLUS Solution Knee System) and standardizing their sizing. There are "no new implant designs included in this premarket notification other than the addition of a size 12 tibial baseplate and size 20mm thick articular inserts." This incremental change does not typically necessitate new clinical trials to prove performance against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information because the document describes a 510(k) submission based on substantial equivalence, not a study evaluating device performance against pre-defined acceptance criteria.

The document details the following:

• Device Name: Smith & Nephew TC-Plus Primary Knee System
• Device Description: A tricompartmental total knee prosthesis comprising femoral, patellar, and tibial components with an ultra-high molecular weight polyethylene articular insert. It combines components from the previously cleared VKS Knee System and TC-PLUS Solution Knee System.
• Indications for Use: Cemented surface replacement in treating patients for primary total knee arthroplasty or revision knee arthroplasty. Specific conditions include degenerative, post-traumatic or rheumatoid arthritis, avascular necrosis, loss of joint configuration, patello-femoral erosion, functional disability, patellectomy, and moderate deformities.
• Predicates:
  • PLUS Orthopedics AG, TC-PLUS Solution Knee (K000666, 10/13/00)
  • PLUS Orthopedics AG, TC-PLUS Porous Femoral Components (K011258, 5/24/01)
  • PLUS Orthopedics AG, VKS Knee System (K022204, 10/18/02)
• Regulatory Classification: Class II, 21 CFR 888.3560 (Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis).

Ask a specific question about this device