FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.)
Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
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.
Pediatric Indications:
Congenital coxa vara.
Congenital dislocation of the hip.
Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

CONQUEST FN:
CONOUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

D-Rad:
The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.

EVOS:
The EVOS MINI Plating System is indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, metatarsals, and clavicle.
The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.
The EVOS Wrist Fracture Plating System is indicated for adult and pediatric patients, as well as patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.

PERI-LOC:
The PERI-LOC Plate and Screw System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and bone 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.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AQ/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, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.
PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with 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; and subtrochanteric femur fractures.
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot. midfoot and hindfoot.
The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12–18 years) and transitional adolescent (18–21 years) subpopulations and adults, as well as patients with osteopenic bone.
The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation. arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones.
The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

TC-100:
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

Cannulated Screws:
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 5.5mm. 6.5mm. 7.0mm. and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and nonunions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid 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.

Device Description

The purpose of this Traditional 510(k) is to add the MR safety information to the labeling, and update the information within the package insert for the Smith & Nephew Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices.

AI/ML Overview

This document describes the Smith & Nephew Plates and Screws Systems, which encompasses several product lines: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws.

Acceptance Criteria and Device Performance:

The document states that the purpose of this 510(k) submission is to add MR safety information to the labeling and update information within the package inserts for the listed devices. It explicitly states: "The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices."

Therefore, the acceptance criteria for this specific submission are not focused on clinical performance metrics of the device for fracture fixation, but rather on the safety and compatibility of the implants within a Magnetic Resonance (MR) environment, as well as ensuring that the updated labeling and package insert information is accurate and appropriate.

Table of Acceptance Criteria and Reported Device Performance:

Since the submission is primarily for adding MR safety information and updating labeling, the "acceptance criteria" here relate to meeting specific MR safety testing standards rather than clinical efficacy metrics.

Acceptance Criteria Category	Specific Criterion (Standard Met)	Reported Device Performance
Magnetic Resonance (MR) Safety	Magnetically induced displacement force (ASTM F2052)	Testing conducted as per FDA guidance and ASTM F2052.
	Magnetically induced torque (ASTM F2213)	Testing conducted as per FDA guidance and ASTM F2213.
	Radiofrequency (RF) induced heating (ASTM F2182)	Testing conducted as per FDA guidance and ASTM F2182.
	MR image artifact (ASTM F2119)	Testing conducted as per FDA guidance and ASTM F2119.
Labeling/Package Insert Update	Accuracy and completeness of MR safety information in labeling.	Information updated in the package insert.
	Accuracy and completeness of other updated information.	Information updated in the package insert.
Design/Material/Manufacturing	No modification to device design, material, or manufacturing.	Confirmed: "No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices."
Functional Equivalence	Identical function and operational principles to predicate devices.	Confirmed: "The Smith & Nephew Plates and Screws Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to the commercially available predicate devices."

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is Magnetic Resonance Imaging (MRI) compatibility testing.

Sample Size used for the test set and data provenance:
- The document does not explicitly state the sample size (number of devices or configurations tested) for the MRI compatibility testing.
- Data Provenance: The testing was conducted "as per the FDA's guidance 'Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment', December 11, 2014 and the standards listed below." This implies the testing was likely prospective, conducted specifically for this submission, and likely performed in a controlled laboratory environment. The country of origin of the data is not specified but would typically be where the testing facility is located (presumably in the US or a country with recognized testing standards for FDA submissions).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For MRI compatibility testing of passive implants, "ground truth" is established by the adherence to and results of standardized tests (ASTM F2052, F2213, F2182, F2119). These tests have defined methodologies for measuring physical properties related to MR safety.
- The document does not mention the use of human experts (e.g., radiologists) for subjective evaluation in this context, as the evaluation is based on objective measurements according to the specified ASTM standards. The "experts" implied are those who developed and validated these ASTM standards and the technical personnel who perform the tests according to the standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of testing. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical image interpretation, not for objective physical property measurements in MRI compatibility testing. The results of the ASTM tests are quantitative measurements.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for surgical implants (bone plates and screws), not for an AI-powered diagnostic device. The study described is MRI compatibility testing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI algorithm. The testing performed is for physical device properties in an MR environment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for MRI compatibility is based on objective, quantitative measurements obtained by following established industry standards (ASTM F2052, F2213, F2182, F2119), as outlined in FDA guidance. These standards define the limits and acceptable performance for implants in an MR environment.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The study is a series of physical tests on the manufactured devices.
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device and submission.

Summary of Conclusion:

The conclusion is that the Smith & Nephew Plates and Screws Systems are substantially equivalent to the predicate devices because the only changes are the addition of MR safety information to the labeling and updates to the package insert. The fundamental device design, material, sterilization, manufacturing processes, and operational principles remain unchanged. The MRI compatibility testing confirms that the devices are safe for use in an MR environment under specified conditions, meeting the relevant ASTM standards and FDA guidance for passive implants.

Summary

Regulation Number and Section

§ 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.