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

{0}------------------------------------------------

June 29, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

Smith & Nephew, Inc. Thomas Fearnley Senior Regulatory Affairs Specialist 1450 E Brooks Rd Memphis, Tennessee 38116

Re: K210837

Trade/Device Name: Smith & Nephew Plates and Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT, HRS, HWC, HTN, NDG, HTY Dated: May 28, 2021 Received: June 1, 2021

Dear Thomas Fearnley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known) K210837

Device Name Compression Hip Screw (CHS)

Indications for Use (Describe)

Adult Indications

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{3}------------------------------------------------

510(k) Number (if known) K210837

Device Name CONQUEST FN

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known) K210837

Device Name D-Rad

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K210837

Device Name EVOS

Indications for Use (Describe)

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 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, 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 with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Number (if known)

Device Name PERI-LOC

Indications for Use (Describe)

The PERI-LOC Plate and Screw System can be used for adult and pediativ 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, 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-OC 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, 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 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 multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft 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, 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 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.

{7}------------------------------------------------

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

{8}------------------------------------------------

510(k) Number (if known) K210837

Device Name TC-100

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{9}------------------------------------------------

510(k) Number (if known) K210837

Device Name Cannulated Screws

Indications for Use (Describe)

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 fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, 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, 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 bone fragments appropriate for 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 non-unions of small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpals, 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.

Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D) [] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Smith & Nephew. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange, matching the color of the flower symbol. The logo is simple and modern, with a focus on the company name.

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	May 28, 2021
Contact Person and Address:	Thomas FearnleySenior Regulatory Affairs SpecialistT 901-399-1224
Name of Device:	Smith & Nephew, Inc. Plates and ScrewsSystems: EVOS, Peri-Loc, D-Rad, TC-100, VLPMini-Mod, Compression Hip Screw (CHS),CONQUEST FN, and cannulated screws
Common Name:	Bone Plates and Screws
Device Classification Nameand Reference:	21 CFR 888.3030 Single/multiple componentmetallic bone fixation appliances and accessories.21 CFR 888.3040 Smooth or threaded metallicbone fixation fastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JDO, KTT, HRS, HWC, HTN, NDG, HTY
Predicate Device:	Smith & Nephew Plates and Screws Systems:EVOS (K201527), Peri-Loc (K120667), D-Rad (K161665), TC-100 (K993106), VLPMini-Mod (K152976), Compression Hip Screw(CHS) (K993289), CONQUEST FN (K193029),and cannulated screws (K133662)

Device Description

No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices.

Indication for Use

Indications for use of the Smith & Nephew, Inc. Plates and Screws are the following:

{11}------------------------------------------------

Compression Hip Screw (CHS)

Adult Indications

1. 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.)
1. Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
1. Osteotomies for patients with diseases or deformities of the hip.
1. Hip arthrodesis.
1. Supracondylar fractures and distal femoral fractures using a supracondylar plate.
1. Ipsilateral femoral shaft/neck fractures.

Pediatric Indications

1. Congenital coxa vara.
1. Congenital dislocation of the hip.
1. Subluxation or dislocation secondary to neurologic disorders such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities.
1. Coxa plana (Legg-Calve-Perthes disease) for containment of the head completely within the acetabulum.

CONQUEST FN

CONQUEST 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.

{12}------------------------------------------------

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.

{13}------------------------------------------------

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

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.

{14}------------------------------------------------

Technological Characteristics

The device design and material of the subject device are same as the predicate 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 cleared under the premarket notifications listed in the tables below.

Performance Data

Below listed Magnetic resonance imaging (MRI) compatibility testing were conducted as per the FDA's quidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards listed below:

1. Magnetically induced displacement force (ASTM F2052)
Magnetically induced torque (ASTM F2213) 2.
1. Radiofrequency (RF) induced heating (ASTM F2182)
1. MR image artifact (ASTM F2119)

Substantial Equivalence Information

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 listed in the tables below.

Table 5.1: Substantially Equivalent Predicates to the Compression Hip Screw (CHS) System

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Smith & NephewCompression Hip Screw(CHS)	K952697 K954712 K993289	09/12/199510/31/199512/20/1999

Table 5.2: Substantially Equivalent Predicates to the CONQUEST FN System

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Smith & NephewCONQUEST FN System	K152686 K172785 K193029	03/17/201612/22/201702/28/2020

Table 5.3: Substantially Equivalent Predicates to the External Fixation Systems

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	D-Rad Plating System	K132296	01/07/2014
		K161665	11/15/2016

Table 5.4: Substantially Equivalent Predicates to the EVOS Plating System

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	EVOS Plating System	K140814	05/07/2014
		K162078	11/18/2016
		K170457	06/14/2017
		K170887	04/24/2017
		K173293	01/08/2018
		K181533	08/09/2018

{15}------------------------------------------------

	K190253	03/11/2019
	K201527	07/22/2020

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Peri-Loc Periarticular andVariable-Angled Locked Plating(VLP) Systems	K033669	12/10/2003
		K051735	07/19/2005
		K061352	06/08/2006
		K062216	09/15/2006
		K071563	08/08/2007
		K072818	11/19/2007
		K080434	04/10/2008
		K082516	09/17/2008
		K083032	01/07/2009
		K090675	06/04/2009
		K092015	07/30/2009
		K100325	05/04/2010
		K110670	07/12/2011
		K120667	04/04/2012
		K132886	02/04/2014
		K143050	12/18/2014
		K152976	11/12/2015

Table 5.5: Substantially Equivalent Predicates to the subject Systems

Table 5.6: Substantially Equivalent Predicates to the TC-100 Screw and Plating System

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	TC-100 Screw and PlatingSystem	K123055	01/25/2013
		K993106	12/09/1999

Table 5.7: Substantially Equivalent Predicates to the Cannulated Screws

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Cannulated Screws	K060736	04/18/2006
		K111994	10/11/2011
		K133662	5/15/2014

Conclusion

In summary, the only differences between the subject devices and what was previously cleared are the addition of MR safety information to the labeling, the indications and the information within the package insert. The Smith & Nephew Plates and Screws Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously cleared. Therefore, it is concluded that the Smith & Nephew Plates and Screws Systems are substantially equivalent to the predicate devices.

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.