TRIGEN META-TAN Trochanteric Antegrade Nail
Device Facts
| Record ID | K243364 |
|---|---|
| Device Name | TRIGEN META-TAN Trochanteric Antegrade Nail |
| Applicant | Smith & Nephew, Inc. |
| Product Code | HSB · Orthopedic |
| Decision Date | Dec 9, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures. In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.
Device Story
The TRIGEN META-TAN Trochanteric Antegrade Nail is an intramedullary fixation rod designed to aid normal fracture healing of the femur. The device is implanted by a surgeon in a clinical setting to provide mechanical stabilization of femoral fractures. It features proximal holes/slots to accept screws that thread into the femoral head, providing compression and rotational stability. The nail is manufactured from Ti-6Al-4V, available in lengths from 30 to 50 cm, and is provided gamma-sterilized for single-use. The device functions as a mechanical support structure; it does not involve electronic inputs, software, or algorithmic processing. Clinical benefit is derived from the stabilization of bone fragments to facilitate healing.
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by bench testing, including MR compatibility testing per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013).
Technological Characteristics
Material: Ti-6Al-4V. Dimensions: 30-50 cm length (2 cm increments). Sterilization: Gamma. Mechanical fixation via intramedullary rod and femoral head screws. MR compatibility standards: ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, ASTM F2119-07(2013).
Indications for Use
Indicated for fixation of femoral fractures in patients with simple long bone, comminuted, spiral, segmental, supracondylar, subtrochanteric, intertrochanteric, or intracapsular fractures occurring between the proximal third and distal fourth of the femur.
Regulatory Classification
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.
Predicate Devices
- SURESHOT TAN NAILS AND ACCESSORIES (K092748)
Related Devices
- K040462 — TRIGEN TROCHANTERIC ANTEGRADE NAIL · Smith & Nephew, Inc. · Mar 23, 2004
- K123569 — ANTEGRADE FEMORAL NAIL · Advanced Orthopaedic Solutions, Inc. · May 24, 2013
- K013563 — LONG TROCHANTERIC NAIL SYSTEM · DePuy Orthopaedics, Inc. · Dec 27, 2001
- K040212 — TRIGEN INTERTAN · Smith & Nephew, Inc. · Feb 20, 2004
- K161466 — ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System · Orthofix Srl · Jan 24, 2017
Submission Summary (Full Text)
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December 9, 2024
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Smith & Nephew, Inc. Jessica Roach Regulatory Affairs Specialist II 1450 E Brooks Road Memphis, Tennessee 38116
Re: K243364
Trade/Device Name: TRIGEN META-TAN Trochanteric Antegrade Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: October 29, 2024 Received: October 29, 2024
Dear Jessica Roach:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2024.12.09
17:54:39 -05'00'
Farzana Sharmin, PhD Assistant 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
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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K243364
Device Name
TRIGEN META-TAN Trochanteric Antegrade Nail
Indications for Use (Describe)
TRIGEN META-TAN Trochanteric Antegrade Nail
The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.
In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric 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)
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| 510(k) #: | 510(k) Summary | K243364 - Page 1 of 2<br>Prepared on: 2024-12-09 | |
|------------------------------------|----------------------------------------------------------|--------------------------------------------------|---------------------|
| Contact Details | | | |
| | | | 21 CFR 807.92(a)(1) |
| Applicant Name | Smith & Nephew, Inc. | | |
| Applicant Address | 1450 E Brooks Road Memphis TN 38116 United States | | |
| Applicant Contact Telephone | 978-474-6318 | | |
| Applicant Contact | Ms. Jessica Roach | | |
| Applicant Contact Email | jessica.roach@smith-nephew.com | | |
| Device Name | | | 21 CFR 807.92(a)(2) |
| Device Trade Name | TRIGEN META-TAN Trochanteric Antegrade Nail | | |
| Common Name | Intramedullary fixation rod | | |
| Classification Name | Rod, Fixation, Intramedullary And Accessories | | |
| Regulation Number | 888.3020 | | |
| Product Code(s) | HSB, HWC | | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | Product Code |
| K092748 | SURESHOT TAN NAILS AND ACCESSORIES | | HSB, HWC |
| | | | |
| | | | |
## Device Description Summary
The device in scope of this submission is the TRIGEN META-TAN Trochanteric Antegrade Nail.
TRIGEN META-TAN Trochanteric Antegrade Nails are intended to be used as aids to normal fracture healing of the femur. They are made from Ti-6Al-4V material and available in a nail size range of 30 to 50 cm in 2 cm increments. They are Gamma sterlized and intended for single-use only.
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(5)
# Intended Use/Indications for Use
TRIGEN META-TAN Trochanteric Antegrade Nail
The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.
In addition, TRIGEN META-TAN Nails cortain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; and intracapsular fractures.
Indications for Use Comparison
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The subject TRIGEN META-TAN Trochanteric Antegrade Nail indications fall within the predicate devices' indications for use.
# Technological Comparison
## 21 CFR 807.92(a)(6)
The overall technological characteristic including device devices are similar to the subject devices are similar to that of the predicate Smith & Nephew system cleared under the premarket notification SURESHOT TAN (K092748, 04/26/2010).
As result, all relevant testing makes references to existing information previously provided to the agency.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
• MR Compatibility per ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013) (META-TAN Nail)
No clinical tests were performed to support safety and efficacy of the subject device.
The performance bench tests were used as a basis for the determination of substantial equivalence. The results of the equivalence testing demonstrate acceptable outcomes. The results of these tests show that when compared to the subject device has met the required criteria and there are no additional risks.
