(592 days)
No
The 510(k) summary describes intramedullary nails and their intended uses. The purpose of this submission is solely to add MR safety information and update the package insert for previously cleared devices. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, "interlocking intramedullary nails," is intended for the fixation of various types of fractures and for reconstruction, following tumor resection and grafting, which are therapeutic interventions.
No
This device is an intramedullary nail system, which is used for the fixation of bone fractures and fusions, indicating it is a therapeutic or reconstructive device, not a diagnostic one. The change to the 510(k) is to update MR safety information, which relates to the safety of the implanted device during MRI, not diagnostic capabilities of the device itself.
No
The device description explicitly states that the submission is for "Smith & Nephew Intramedullary Nail Systems," which are physical implants used for bone fixation. The purpose of this 510(k) is to add MR safety information to the labeling of these physical devices, not to introduce a new software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe the device as an implantable medical device used for the fixation of bone fractures and fusions. This involves surgical procedures on the human body.
- Device Description: The device is described as "Intramedullary Nail Systems," which are physical implants. The purpose of the 510(k) is to add MR safety information and update labeling for these implants.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
- Trigen Antegrade Tibial/Retrograde Femoral Nailing System: Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Intramedulary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures. In addition to the indications for intramedulary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).
- Trigen Tan/Fan Nailing System: Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability ( e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/ neck fractures. In addition to the indications for interlocking intramedulary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and SupracondylarNails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic fractures).
- Trigen Hindfoot Fusion Nail System: Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following; degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot: tibiocalcaneal arthrodesis of the ankle and sub-talar joints; ayascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; theumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe with trauma to the sub-talar joint.
- Trigen Humeral Nail System: The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, malalignments, pathological humeral fractures, and impending pathological fractures.
- Trigen Intertan Intertrochanteric Antegrade Nail System: The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral fractures; intertrochanteric fractures; and intracapsular fractures.
- Trigen Knee Fusion Nail System: Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDS
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 Intramedullary Nail Systems. The Smith & Nephew Intramedullary Nail Systems consist of the following previously cleared devices:
- Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. . 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006)
- The Trigen Antegrade Tibial/Retrograde Femoral Nailing System includes retrograde femoral, supercondylar, and tibial intramedullary nails, and nail cap. All described components are manufactured from titanium material.
- Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998, , K040929 S.E. 5/25/2004, ● and K111025 S.E. 7/1/2011)
- The Trigen Tan/Fan Nailing System includes trochanteric antegrade nails and femoral antegrade nails, femoral and tibial nails and low profile bone screws. All components are manufactured from titanium alloy.
- Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) .
- The Trigen Hindfoot Fusion Nail System includes right and left nail designs in 10 mm and 11.5 mm with nail lengths ranging from 16-25 ст.
- . Trigen Humeral Nail System (K032722 S.E. 10/1/2003)
- The Trigen Humeral Nail System includes both a proximal fracture nail - (8 mm diameter and 16 cm length) and a shaft fracture nail (8 to 10 mm diameter and 18 to 28 cm lengths) with features of a diverging proximal screw hole pattern for better stability. All components are made of titanium material.
- Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) ●
- The Trigen Intertan Intertrochanteric Antegrade Nail System includes right and left nail designs as well as a universal nail which can be used for both left or right side fracture. All described nails are manufactured from titanium material.
- . Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005)
- The Trigen Knee Fusion Nail System includes intramedullary interlocking nails with corresponding screws. All components are made of titanium material.
The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices as a part of this subject 510(k).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones, femoral head, knee joint, tibiotalar and talocalcaneal articulations of the hindfoot, ankle and sub-talar joints, humerus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 was conducted as per the FDA's guidance and the Standards listed below.
- FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20 May 2021.
- Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
- IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment –Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015).
- ASTM F2182-19e2, "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging" (2020).
- ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device".
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2213-2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
- ASTM F2119-07 (2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Key results: The only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of MR safety information to the labeling. These differences are not critical to the intended use of the subject devices and do not change the indications for use. Due to the supporting testing and evidence within this filing, it is concluded that the Smith & Nephew Intramedullary Nail Systems are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K981529 S.E. 7/9/1998, K051557 S.E. 6/30/2005, K061019 S.E. 6/6/2006, K040929 S.E. 5/25/2004, K111025 S.E. 7/1/2011, K043052 S.E. 11/24/2004, K032722 S.E. 10/1/2003, K040212 S.E. 2/20/2004, K050938 S.E. 5/4/2005
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
November 14, 2022
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 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.
Smith & Nephew, Inc. Michelle Huettner Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K210980
Trade/Device Name: Smith & Nephew Intramedullary Nail Systems Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, JDS Dated: November 8, 2022 Received: November 8, 2022
Dear Michelle Huettner:
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 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
1
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 mediation-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,
Digitally signed by Farzana Earzana Sharmin -9 Sharmin -S
For Victoria Lilling, M.D. Assistant Division Director DHT6A: Division of Joint Arthroplasty 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) K210980
Device Name
Trigen Antegrade Tibial/Retrograde Femoral Nailing System
Indications for Use (Describe)
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Intramedulary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.
In addition to the indications for intramedulary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 comblete 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."
3
510(k) Number (if known) K210980
Device Name
Trigen Tan/Fan Nailing System
Indications for Use (Describe)
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability ( e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/ neck fractures.
In addition to the indications for interlocking intramedulary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and SupracondylarNails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic 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
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
4
510(k) Number (if known) K210980
Device Name Trigen Hindfoot Fusion Nail System
Indications for Use (Describe)
Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following; degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot: tibiocalcaneal arthrodesis of the ankle and sub-talar joints; ayascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; theumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe with trauma to the sub-talar joint.
| 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
"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: 06/30/2023
See PRA Statement below.
5
510(k) Number (if known) K210980
Device Name Trigen Humeral Nail System
Indications for Use (Describe)
The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, malalignments, pathological humeral fractures, and impending pathological 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
6
510(k) Number (if known) K210980
Device Name
Trigen Intertan Intertrochanteric Antegrade Nail System
Indications for Use (Describe)
The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral fractures; intertrochanteric fractures; and intracapsular 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
7
510(k) Number (if known) K210980
Device Name Trigen Knee Fusion Nail System
Indications for Use (Describe) Knee Fusion Nails are intended for intramedullary knee arthrodesis.
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
8
510(k) Summary
| Submitted by: | Smith & Nephew, Inc. |
|---|---|
| Orthopaedic Division | |
| 7135 Goodlett Farms Parkway | |
| Cordova, Tennessee 38016 | |
| Date of Submission: | November 7, 2022 |
| Contact Person: | Senior Manager, Regulatory Affairs |
| Email: Rose.Beifuss@smith-nephew.com | |
| Phone: (385) 253-2551 | |
| Name of Device: | Smith & Nephew Intramedullary Nail Systems |
| Trigen Antegrade Tibial/Retrograde Femoral | |
| Nailing System Trigen Tan/Fan Nailing System Trigen Hindfoot Fusion Nail System Trigen Humeral Nail System Trigen Intertan Intertrochanteric Antegrade Nail | |
| System Trigen Knee Fusion Nail System | |
| Common Name: | Intramedullary Nails |
| Device Classification Name and | |
| Reference: | 21 CFR 888.3020 – Intramedullary fixation rod with |
| corresponding Product Code HSB |
9
21 CFR 888.3030 – Single/multiple component metallic bone fixation appliances and accessories with corresponding Product Codes JDS
| Device Class: | Class II |
|---|---|
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSB - Intramedullary fixation rod |
| JDS - Single/multiple component metallic bone fixation | |
| appliances and accessories | |
| Predicate Device: | Smith & Nephew Intramedullary Nail Systems |
| • Trigen Antegrade Tibial/Retrograde Femoral | |
| Nailing System (K981529 S.E. 7/9/1998, K051557 | |
| S.E. 6/30/2005 and K061019 S.E. 6/6/2006) | |
| • Trigen Tan/Fan Nailing System (K981529 S.E. | |
| 7/9/1998 K040929 S.E.5/25/2004, and K111025 | |
| S.E. 7/1/2011) | |
| • Trigen Hindfoot Fusion Nail System (K043052 | |
| S.E. 11/24/2004) | |
| • Trigen Humeral Nail System (K032722 S.E. | |
| 10/1/2003) | |
| • Trigen Intertan Intertrochanteric Antegrade Nail | |
| System (K040212 S.E. 2/20/2004) | |
| • Trigen Knee Fusion Nail System (K050938 S.E. | |
| 5/4/2005) |
10
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 Intramedullary Nail Systems. The Smith & Nephew Intramedullary Nail Systems consist of the following previously cleared devices:
- Trigen Antegrade Tibial/Retrograde Femoral Nailing System (K981529 S.E. . 7/9/1998, K051557 S.E. 6/30/2005 and K061019 S.E. 6/6/2006)
- The Trigen Antegrade Tibial/Retrograde Femoral Nailing System includes retrograde femoral, supercondylar, and tibial intramedullary nails, and nail cap. All described components are manufactured from titanium material.
- Trigen Tan/Fan Nailing System (K981529 S.E. 7/9/1998, , K040929 S.E. 5/25/2004, ● and K111025 S.E. 7/1/2011)
- The Trigen Tan/Fan Nailing System includes trochanteric antegrade nails and femoral antegrade nails, femoral and tibial nails and low profile bone screws. All components are manufactured from titanium alloy.
- Trigen Hindfoot Fusion Nail System (K043052 S.E. 11/24/2004) .
- The Trigen Hindfoot Fusion Nail System includes right and left nail designs in 10 mm and 11.5 mm with nail lengths ranging from 16-25 ст.
- . Trigen Humeral Nail System (K032722 S.E. 10/1/2003)
- The Trigen Humeral Nail System includes both a proximal fracture nail - (8 mm diameter and 16 cm length) and a shaft fracture nail (8 to 10 mm diameter and 18 to 28 cm lengths) with features of a diverging proximal screw hole pattern for better stability. All components are made of titanium material.
- Trigen Intertan Intertrochanteric Antegrade Nail System (K040212 S.E. 2/20/2004) ●
- The Trigen Intertan Intertrochanteric Antegrade Nail System includes right and left nail designs as well as a universal nail which can be used for both left or right side fracture. All described nails are manufactured from titanium material.
- . Trigen Knee Fusion Nail System (K050938 S.E. 5/4/2005)
11
- The Trigen Knee Fusion Nail System includes intramedullary interlocking nails with corresponding screws. All components are made of titanium material.
The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices as a part of this subject 510(k).
Indications for Use
Trigen Antegrade Tibial/Retrograde Femoral Nailing System
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.
In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).
12
Trigen Tan/Fan Nailing System
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/ neck fractures.
In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic fractures).
Trigen Hindfoot Fusion Nail System
Indications for the TRIGEN Hindfoot Fusion Nail (HFN) include the following: degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations of the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the sub-talar joint.
13
Trigen Humeral Nail System
The TRIGEN Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
Trigen Intertan Intertrochanteric Antegrade Nail System
The TRIGEN InterTAN nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.
Trigen Knee Fusion Nail System
Knee Fusion Nails are intended for intramedullary knee arthrodesis.
Technological Characteristics
The overall device design and material of the subject devices are the predicate Smith & Nephew Intramedullary Nail Systems cleared under the premarket notifications listed in Table 5.1.
14
Substantial Equivalence Information
The Smith & Nephew Intramedullary Nail Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to the commercially available predicate devices listed in Table 5.1 below.
| Manufacturer | Description | Submission
Number | Clearance
Date | Product
Code |
|----------------|--------------------------------------------------------------|-------------------------------|-----------------------------------|-----------------|
| Smith & Nephew | Trigen Antegrade Tibial/Retrograde
Femoral Nailing System | K981529
K051557
K061019 | 7/9/1998
6/30/2005
6/6/2006 | JDS |
| Smith & Nephew | Trigen Hindfoot Fusion Nail System | K043052 | 11/24/2004 | HSB |
| Smith & Nephew | Trigen Tan/Fan Nailing System | K981529K0409
29K111025 | 7/9/1998
5/25/2004
7/1/2011 | JDS
HSB |
| Smith & Nephew | Trigen Humeral Nail System | K032722 | 10/1/2003 | HSB |
| Smith & Nephew | Trigen Intertan Intertrochanteric
Antegrade Nail System | K040212 | 2/20/2004 | JDS |
| Smith & Nephew | Trigen Knee Fusion Nail System | K050938 | 5/4/2005 | JDS |
Table 5.1: Substantially Equivalent Predicates to the Intramedullary Nail Systems
15
Performance Data
Below listed Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed below.
-
- FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20 May 2021.
-
- Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016
-
- IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment –Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015).
-
- ASTM F2182-19e2, "Standard Test Method for Measurement of Radio Frequency
-
- Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging" (2020).
-
- ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device".
-
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
-
- ASTM F2213-2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
-
- ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
-
- ASTM F2119-07 (2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Conclusion
In summary, the only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of MR safety information to the labeling. These differences are not critical to the intended use of the subject devices and do not change the indications for use. Due to the supporting testing and evidence within this filing, it is concluded that the Smith & Nephew Intramedullary Nail Systems are substantially equivalent to the predicate devices.