(367 days)
K933027, K952697, K954712, K993289, K210837, K152686, K172785, K193029, K210837, K132296, K161665, K210837, K140814, K162078, K170457, K170887, K173293, K181533, K190253, K201527, K201918, K203405, K210837, K033669, K051735, K061352, K062216, K071563, K072818, K080434, K082516, K083032, K090675, K092015, K100325, K110670, K120667, K132886, K143050, K152976, K210837, K123055, K993106, K210837, K060736, K111994, K133662, K210837
Not Found
No
The summary focuses on the intended use, device description (primarily material and design), and MRI compatibility testing of bone plates and screws. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The purpose of the 510(k) is stated as updating MR safety information for existing devices.
Yes
The device is described as a plating and screw system for fracture fixation, arthrodesis, reconstruction, and other orthopedic procedures, which are all therapeutic interventions.
No
The device description clearly states its purpose is for fracture fixation, arthrodesis, reconstruction, and reduction of bone fragments, which are therapeutic functions. It is a plating and screw system, not a device used to identify or diagnose a condition.
No
The device description explicitly states that the purpose of the 510(k) is to update MR safety information for "Smith & Nephew Plates and Screws Systems," which are physical implants used for fracture fixation and other orthopedic procedures. The submission is for hardware devices, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly describes the device as a system of plates and screws used for the surgical fixation of bone fractures, arthrodesis, reconstruction, and other orthopedic procedures. These are all procedures performed in vivo (within the living body).
- Device Description: The description confirms the device is a system of plates and screws used for orthopedic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the living body) to analyze biological samples. This device is an implantable medical device used in vivo.
N/A
Intended Use / Indications for Use
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 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 pediatic patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
PERI-LOC
The PERI-LOC Plate and Screw System can be used for adult and pediatic 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, humerus, ulna, radius, calcaneus, and clavicle.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatic patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and for fracture fixation of the firstion of the firstilula. 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 fenur osteotonies: 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 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 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.
D-Rad
The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.
TC-100
Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatic as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
Compression Hip Screw (CHS)
- Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more 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 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.
CONQUEST FN
CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
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, metatarsals, patella, ultar 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 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 non-unions of small bone fragments; arthrodeses of small ioints; bunionectomies and osteotomies; scaphoid and other carpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smith & Nephew 2.0mm OFX Screw is indicated for osteotomies of the lesser metatarsals, such as Well osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
Product codes
JDO, KTT, HRS, HWC, HTN, NDG, HTY
Device Description
The purpose of this Traditional 510(k) is to update the MR safety information 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
EVOS: small bones, small bone fragments, long bones, tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, clavicle, distal and proximal tibia, wrist
PERI-LOC: pelvic, small and long bone fractures, tibia, fibula, femur, pelvis, acetabulum, metacarpals, humerus, ulna, radius, calcaneus, clavicle, distal and proximal tibia, medial malleolus, fibula, distal ulna, olecranon, calcaneus, metatarsals, trochanteric region (intertrochanteric, reverse oblique trochanteric, transverse trochanteric, subtrochanteric), proximal femur, femoral neck (basi/transcervical, subcapital), forefoot, midfoot, hindfoot, distal tibia, talus, ankle, wrist
D-Rad: distal radius
TC-100: pelvic, small, and long bones, tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand, middle foot bones, calcaneus, hip
Compression Hip Screw (CHS): femoral neck, hip, femur
CONQUEST FN: femoral neck
Cannulated Screws: small bones, small joints, scaphoid, carpal bones, metatarsals, patella, ulnar styloid, capitellum, radial head, radial styloid, bone fragments, foot, ankle, intraarticular and extra-articular fractures, small bones, small bone fragments, small joints, phalanges, metacarpals, carpals of the hand
Indicated Patient Age Range
EVOS: adolescent (12-18 years), transitional adolescent (18-21 years), adults, pediatric
PERI-LOC: adult, pediatric, adolescent (12-18 years), transitional adolescent (18-21 years)
D-Rad: Not Specified
TC-100: adult, pediatric
Compression Hip Screw (CHS): Not Specified
CONQUEST FN: Not Specified
Cannulated Screws: Not Specified
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Magnetic resonance imaging (MRI) compatibility testing were 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:
- Magnetically induced displacement force (ASTM F2052)
- Magnetically induced torque (ASTM F2213)
- Radiofrequency (RF) induced heating (ASTM F2182)
- MR image artifact (ASTM F2119)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K933027, K952697, K954712, K993289, K210837, K152686, K172785, K193029, K210837, K132296, K161665, K210837, K140814, K162078, K170457, K170887, K173293, K181533, K190253, K201527, K201918, K203405, K210837, K033669, K051735, K061352, K062216, K071563, K072818, K080434, K082516, K083032, K090675, K092015, K100325, K110670, K120667, K132886, K143050, K152976, K210837, K123055, K993106, K210837, K060736, K111994, K133662, K210837
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 29, 2022
Smith & Nephew Inc. Rose Beifuss Senior Regulatory Affairs Manager 1450 E Brooks Rd Memphis, Tennessee 38116
Re: K213126
Trade/Device Name: Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated 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: August 19, 2022 Received: August 22, 2022
Dear Rose Beifuss:
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.
1
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 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.
For: Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
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 pediatic patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone 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.
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)
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, metacarpals, humerus, ulna, radius, calcaneus, and clavicle.
PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatic patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and for fracture fixation of the firstion of the firstilula. 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 fenur osteotonies: 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 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 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.
4
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
5
510(k) Number (if known) K213126
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### 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
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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 as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarsals, 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.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213126
Device Name
Compression Hip Screw (CHS)
Indications for Use (Describe)
- Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more 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 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.
| CHOOLEAN COLLEGIAL And Antitle AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA | Company of Area Annual Andrew of Children Company | ||
|---|---|---|---|
| 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.
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
8
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name CONQUEST FN
Indications for Use (Describe) CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.
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.
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
9
510(k) Number (if known)
K213126
Device Name Cannulated Screws
Indications for Use (Describe)
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, ultar 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 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 non-unions of small bone fragments; arthrodeses of small ioints; bunionectomies and osteotomies; scaphoid and other carpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smith & Nephew 2.0mm OFX Screw is indicated for osteotomies of the lesser metatarsals, such as Well osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
| 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Image /page/10/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of "We are" is the text "smith&nephew" in orange. The logo is clean and modern, with a focus on the company name.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | August 19, 2022 |
| Contact Person and Address: | Rose Beifuss
Senior Manager, Regulatory Affairs
T 385-253-2551 |
| Name of Device: | Smith & Nephew, Inc. Plates and Screws
Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP
Mini-Mod, Compression Hip Screw (CHS),
CONQUEST FN, and cannulated screws |
| Common Name: | Bone Plates and Screws |
| Device Classification Name
and Reference: | 21 CFR 888.3030 Single/multiple component
metallic bone fixation appliances and accessories. |
| | 21 CFR 888.3040 Smooth or threaded metallic
bone fixation fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JDO, KTT, HRS, HTN, NDG, HWC, HTY |
| Predicate Device: | 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
Device Description
The purpose of this Traditional 510(k) is to update the MR safety information 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.
Indication for Use
Indications for use of the Smith & Nephew, Inc. Plates and Screws are the following:
Compression Hip Screw (CHS)
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- 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.)
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- Trochanteric or subtrochanteric fractures with appropriate additional postoperative precautions about weight bearing and more than sedentary activity.
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- 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.
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.
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.
The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.
PERI-LOC
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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 (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 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 reqion 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.
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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, fibula, 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.
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 guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards listed below:
-
- Magnetically induced displacement force (ASTM F2052)
-
- Magnetically induced torque (ASTM F2213)
-
- Radiofrequency (RF) induced heating (ASTM F2182)
-
- MR image artifact (ASTM F2119)
Substantial Equivalence Information
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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) | |||
|---|---|---|---|
| Svstem | |||
| Manufacturer | Description | Submission | |
| Number | Clearance Date | ||
| Smith & Nephew, | |||
| Inc. | Smith & Nephew | ||
| Compression Hip Screw | |||
| (CHS) | K933027 | 02/22/1994 | |
| K952697 | 09/12/1995 | ||
| K954712 | 10/31/1995 | ||
| K993289 | 12/20/1999 | ||
| K210837 | 06/29/2021 |
Table 5.2: Substantially Equivalent Predicates to the CONQUEST FN System
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|--------------------------------------|----------------------|----------------|
| Smith & Nephew,
Inc. | Smith & Nephew
CONQUEST FN System | K152686 | 03/17/2016 |
| Smith & Nephew, | Smith & Nephew | K172785 | 12/22/2017 |
| Inc. | CONQUEST FN System | K193029 | 02/28/2020 |
| | | K210837 | 06/29/2021 |
Table 5.3: Substantially Equivalent Predicates to the External Fixation Systems
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|----------------------|-------------------------------|----------------------------------------|
| Smith & Nephew,
Inc. | D-Rad Plating System | K132296
K161665
K210837 | 01/07/2014
11/15/2016
06/29/2021 |
Table 5.4: Substantially Equivalent Predicates to the EVOS Plating System
| Manufacturer | Description | Submission
Number | 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 |
| | | K190253 | 03/11/2019 |
| | | K201527 | 07/22/2020 |
| | | K201918 | 11/16/2020 |
| | | K203405 | 01/27/2021 |
| | | K210837 | 06/29/2021 |
Table 5.5: Substantially Equivalent Predicates to the subject Systems
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|-------------------------------------------------------------------------------|----------------------|----------------|
| Smith & Nephew,
Inc. | Peri-Loc Periarticular and
Variable-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 |
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| 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 |
| K210837 | 06/29/2021 |
| Table 5.6: Substantially Equivalent Predicates to the TC-100 Screw and Plating System | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | --------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|------------------------------------|-------------------------------|----------------------------------------|
| Smith & Nephew,
Inc. | TC-100 Screw and Plating
System | K123055
K993106
K210837 | 01/25/2013
12/09/1999
06/29/2021 |
Table 5.7: Substantially Equivalent Predicates to the Cannulated Screws
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|-------------------|----------------------|----------------|
| Smith & Nephew,
Inc. | Cannulated Screws | K060736 | 04/18/2006 |
| | | K111994 | 10/11/2011 |
| | | K133662 | 5/15/2014 |
| | | K210837 | 06/29/2021 |
Conclusion
In summary, the only differences between the subject devices and what was previously cleared is the updated MR safety 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.