(106 days)
Titan Tibial Nail (K003018)
No
The device description and performance studies focus on the mechanical properties, biocompatibility, and targeting accuracy of physical implants and instruments for fracture fixation. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML in medical devices.
Yes
The device is an internal fixation system for fractures, nonunions, and malunions, which are conditions that benefit from therapeutic intervention to stabilize and heal bone.
No
Explanation: The device is an internal fixation system (intramedullary nails, screws, and instruments) used for stabilizing fractures and correcting osteotomies. Its purpose is treatment and stabilization, not the diagnosis of a condition.
No
The device description explicitly states that the system includes sterile implants (intramedullary nails, compression screw, end caps) and non-sterile instruments (targeting devices, surgical instruments), which are physical hardware components.
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 clearly describes the device as an "internal fixation device" used for stabilizing bone fractures and related conditions in the tibia and femur. This is a surgical implant used in vivo (within the body).
- Device Description: The description details the components as "sterile implants (intramedullary nails... compression screw and end caps)" and "non-sterile instruments (targeting devices)". These are physical devices used in surgical procedures.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The provided text does not mention any testing of biological samples or diagnostic purposes.
The device described is a system for surgically fixing bone fractures, which falls under the category of orthopedic implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
T2 Alpha Tibia Nailing System
The indications for use of this internal fixation device include:
- Open and closed tibial fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections
- Fractures involving osteopenic and osteoporotic bone
- Nonunion and malunion
The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.
IMN Screws System
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
IMN Instruments System
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
T2 Alpha Femur Antegrade GT/PF Nailing System
The indications for use of these internal fixation devices include:
- Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- Femoral fixation required as a result of pathological disease
- Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
- Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty
- Nonunions and malunions
- Fractures involving osteopenic and osteoporotic bone
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
Device Description
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market:
- The T2 Alpha Tibia Nailing System,
- . Line extension of IMN Screws System (addition of advanced locking screws),
- . Line extension of IMN Instruments System (addition of surgical instruments),
- . Compatibility of T2 Alpha Femur Antegrade GT/PF Nailing System with IMN Screws System as well as IMN Instruments System, and devices of T2 Alpha Tibia Nailing System
The intended use and indications for use of existing T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System and IMN Instruments System previously cleared in K172774 remain unchanged.
This submission encompasses multiple systems (T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System and IMN Instruments System) that have similar intended use and will be used together during the surgical procedure.
T2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter, compression screw and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The T2 Alpha Tibia Nailing System will be used with the locking screws cleared in K003018 (Titan Tibial Nail) and K172774 (IMN Screws System). Further, End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with T2 Alpha Femur Antegrade GT/PF Nailing System (K172774). The T2 Alpha Tibia Nailing System will be used with the existing instruments previously cleared in K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Tibia Nailing System is intended for use with IMN Screws System and IMN Instruments System.
IMN Screws System
The IMN Screws System includes bone screws (locking screws previously cleared in K172774 and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.
IMN Instruments System
The IMN Instruments System includes distal targeting device femur antegrade previously cleared in K172774 as well as surgical instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K172774 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments.
The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws originally cleared in K003018 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K010801, T2 Femoral Nail System) as well as locking screws previously cleared in K172774 (IMN Screws System) and the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System). Further, it will be used with the existing instruments previously cleared in K172774 (IMN Instruments System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia, Femur
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)
T2 Alpha Tibia Nailing System
Non-clinical testing was performed for T2 Alpha Tibia Nailing System under worst case scenario to determine substantial equivalence. The following bench testing was conducted:
- Testing of mechanical properties per ASTM F1264
- Fatigue strength testing (proximal and distal)
- Cut-out testing
- Targeting accuracy testing
Testing demonstrated that T2 Alpha Tibia Nailing System is equivalent in mechanical performance to the predicate devices (K003018, K082770, and K040762).
Non-clinical testing has demonstrated that T2 Alpha Tibia Nailing System is MR Conditional.
Biocompatibility testing (ISO 10993-1, ISO 10993-5 and ISO 10993-18) was performed to evaluate the biological safety of T2 Alpha Tibia Nailing System according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. Testing demonstrated that T2 Alpha Tibia Nailing System is biocompatible.
The Bacterial Endotoxin Testing demonstrated that the sterile implants of T2 Alpha Tibia Nailing System meet the specified endotoxin limit.
IMN Screws System
Non-clinical testing was performed for the advanced locking screws of IMN Screws System. The following bench testing was conducted:
- Testing of mechanical properties as per ASTM F543
Testing demonstrated that the advanced locking screws are equivalent in mechanical performance to the predicate device (K172774) and reference device (K003018).
Non-clinical testing has demonstrated that the advanced locking screws are MR Conditional.
Biocompatibility assessment (ISO 10993-1) was performed according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. It has been demonstrated that the advanced locking screws are biocompatible. The Bacterial Endotoxin Testing demonstrated that the advanced locking screws meet the specified endotoxin limit.
IMN Instruments System
Non-clinical testing was performed for the surgical instruments of IMN Instruments System. The following bench testing was conducted:
- Performance testing in cadaver lab, and
- Compatibility evaluation
Testing demonstrated that the surgical instruments are equivalent in performance to the predicate device (K172774).
Biocompatibility testing (ISO 10993-1, ISO 10993-5, and ISO 10993-18) was performed according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. It has been demonstrated that the surgical instruments are biocompatible.
T2 Alpha Femur Antegrade GT/PF Nailing System
Non-clinical testing was performed for T2 Alpha Femur Antegrade GT/PF Nailing System to determine substantial equivalence. Compatibility assessment demonstrated that T2 Alpha Femur Antegrade GT/PF Nailing System is suitable to be used with the advanced locking screws of IMN Screws System and the surgical instruments of IMN Instruments System as well as the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System.
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.
T2 Alpha Tibia Nailing System: Titan Tibial Nail (K003018), Zimmer Natural Nail System Tibial Nail (K082770), Synthes (USA) Tibial Nail System EX (K040762)
IMN Screws System: IMN Screws System (K172774)
IMN Instruments System: IMN Instruments System (K172774)
T2 Alpha Femur Antegrade GT/PF Nailing System: T2 Alpha Femur Antegrade GT/PF Nailing System (K172774)
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.
Titan Tibial Nail (K003018)
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
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.
June 6, 2018
Stryker Trauma GmbH Heike Gustke Staff Regulatory Affairs Specialist Prof-Kuentscher-Str. 1-5 Schoenkirchen, 24232 De
Re: K180436
Trade/Device Name: T2 Alpha Tibia Nailing System. T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: April 30, 2018 Received: May 4, 2018
Dear Dr. Gustke:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) |
Device Name
T2 Alpha Tibia Nailing System
Indications for Use (Describe)
The indications for use of this internal fixation device include:
-
Open and closed tibial fractures
-
Pseudoarthrosis and correction osteotomy
-
Pathologic fractures, impending pathologic fractures, and tumor resections
-
Fractures involving osteopenic and osteoporotic bone
-
Nonunion and malunion
The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.
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 FDA 3881 (7/17)
Page 1 of 1
3
Traditional 510(k) Premarket Notification
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K180436
Device Name
T2 Alpha Femur Antegrade GT/PF Nailing System
Indications for Use (Describe)
The indications for use of these internal fixation devices include:
-
Fixation of subtrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaff fractures
-
Femoral fixation required as a result of pathological disease
-
Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
-
Open and closed femoral fractures
-
Pseudoarthrosis and correction osteotomy
-
Pathologic fractures, impending pathologic fractures and tumor resections
-
Ipsilateral femur fractures
-
Fractures proximal to a total knee arthroplasty
-
Nonunions and malunions
-
Fractures involving osteopenic and osteoporotic bone
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 FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
4
Traditional 510(k) Premarket Notification
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K180436 |
|---|---|
| Device Name | IMN Screws System |
Indications for Use (Describe)
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
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 FDA 3881 (7/17)
5
Traditional 510(k) Premarket Notification
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
| ------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number (if known) | K180436 |
|---|---|
| -------------------------- | --------- |
Device Name
IMN Instruments System
Indications for Use (Describe)
The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.
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 FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
6
Section 9: 510(k) Summary I. SUBMITTER
| I. SUBMITTER | | Regulation Number / Name: | T2 Alpha Tibia Nailing System
21CFR 888.3020 (Intramedullary fixation rod)
T2 Alpha Femur Antegrade GT/PF Nailing System
21CFR 888.3020 (Intramedullary fixation rod)
IMN Screws System
21CFR 888.3040 (Smooth or threaded metallic bone fixation
fastener)
IMN Instruments System
21CFR 888.3020 (Intramedullary fixation rod) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Stryker Trauma GmbH
Prof.-Kuentscher-Str. 1-5
24232 Schoenkirchen / Germany | Product Code: | T2 Alpha Tibia Nailing System
HSB (Rod, fixation, intramedullary and accessories)
T2 Alpha Femur Antegrade GT/PF Nailing System
HSB (Rod, fixation, intramedullary and accessories)
IMN Screws System
HWC (Screw, fixation, bone)
IMN Instruments System
HSB (Rod, fixation, intramedullary and accessories) |
| Contact Person: | Dr. Heike Gustke
Staff Regulatory Affairs Specialist
Prof.-Kuentscher-Str. 1-5
24232 Schoenkirchen / Germany
heike.gustke@stryker.com
Phone: +49 4348 702 637
Fax: +49 4348 702 8637 | Regulatory Class: | Class II |
| Date Prepared: | February 5, 2018 | | |
| II. DEVICE | | | |
| Name of Device: | T2 Alpha Tibia Nailing System
T2 Alpha Femur Antegrade GT/PF Nailing System
IMN Screws System
IMN Instruments System | | |
| Common Name: | T2 Alpha Tibia Nailing System
Rod, fixation, intramedullary and accessories
T2 Alpha Femur Antegrade GT/PF Nailing System
Rod, fixation, intramedullary and accessories
IMN Screws System
Screw, fixation, bone
IMN Instruments System
Rod, fixation, intramedullary and accessories | | |
7
III. PREDICATE DEVICE
IMN Screws System
| T2 Alpha Tibia Nailing System | |
|---|---|
| Primary predicate device: | Titan Tibial Nail (K003018) |
| Additional predicate devices: | Zimmer Natural Nail System Tibial Nail (K082770) |
| Synthes (USA) Tibial Nail System EX (K040762) |
| Predicate device: | IMN Screws System (K172774) |
|---|---|
| Reference device: | Titan Tibial Nail (K003018) |
8
Traditional 510(k) Premarket Notification
IMN Instruments System
| Predicate device: | IMN Instruments System (K172774) |
|---|---|
| ------------------- | ---------------------------------- |
T2 Alpha Femur Antegrade GT/PF Nailing System
Predicate device: T2 Alpha Femur Antegrade GT/PF Nailing System (K172774)
IV. DEVICE DESCRIPTION
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market:
- The T2 Alpha Tibia Nailing System, ●
- . Line extension of IMN Screws System (addition of advanced locking screws),
- . Line extension of IMN Instruments System (addition of surgical instruments),
- . Compatibility of T2 Alpha Femur Antegrade GT/PF Nailing System with IMN Screws System as well as IMN Instruments System, and devices of T2 Alpha Tibia Nailing System
The intended use and indications for use of existing T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System and IMN Instruments System previously cleared in K172774 remain unchanged.
This submission encompasses multiple systems (T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System and IMN Instruments System) that have similar intended use and will be used together during the surgical procedure.
T2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter, compression screw and end caps) as well as non-sterile instruments (targeting devices). The sterile implants are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The T2 Alpha Tibia Nailing System will be used with the locking screws cleared in K003018 (Titan Tibial Nail) and K172774 (IMN Screws System). Further, End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with T2 Alpha Femur Antegrade GT/PF Nailing System (K172774). The T2 Alpha Tibia Nailing System will be used with the existing instruments previously cleared in
9
K131365 (T2 Tibial Nailing System) and 510(k) exempt devices. The T2 Alpha Tibia Nailing System is intended for use with IMN Screws System and IMN Instruments System.
IMN Screws System
The IMN Screws System includes bone screws (locking screws previously cleared in K172774 and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6A14V ELI) as per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Instruments System.
IMN Instruments System
The IMN Instruments System includes distal targeting device femur antegrade previously cleared in K172774 as well as surgical instruments that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System and IMN Screws System.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K172774 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw, set screws and end caps) as well as non-sterile instruments.
The T2 Alpha Femur Antegrade GT/PF Nailing System will be used with the locking screws originally cleared in K003018 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K010801, T2 Femoral Nail System) as well as locking screws previously cleared in K172774 (IMN Screws System) and the T2 Lag Screw Recon previously cleared in K032898 (T2 Recon Nail System). Further, it will be used with the existing instruments previously cleared in K172774 (IMN Instruments System) and 510(k) exempt devices. The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for use with IMN Screws System and IMN Instruments System.
10
Traditional 510(k) Premarket Notification
V. INTENDED USE
T2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
IMN Screws System
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
IMN Instruments System
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
VI. INDICATION FOR USE
T2 Alpha Tibia Nailing System
The indications for use of this internal fixation device include:
- . Open and closed tibial fractures
- . Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- . Fractures involving osteopenic and osteoporotic bone
- . Nonunion and malunion
The End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF may also be used in conjunction with the T2 Alpha Femur Antegrade GT/PF Nailing System.
IMN Screws System
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
11
IMN Instruments System
The IMN Instruments System is intended to enable the implantation and extraction of intramedullary nail and screw.
T2 Alpha Femur Antegrade GT/PF Nailing System
The indications for use of these internal fixation devices include:
- . Fixation of subtrochanteric, intertrochanteric, ipsilateral neck/shaft, comminuted proximal femoral shaft fractures
- . Femoral fixation required as a result of pathological disease
- . Temporary stabilization of fractures of the femoral shaft ranging from the femoral neck to the supracondylar regions of the femur
- . Open and closed femoral fractures
- . Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures and tumor resections
- . Ipsilateral femur fractures
- . Fractures proximal to a total knee arthroplasty
- . Nonunions and malunions
- Fractures involving osteopenic and osteoporotic bone ●
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
T2 Alpha Tibia Nailing System
Device comparison demonstrated that the T2 Alpha Tibia Nailing System is substantially equivalent to the previously cleared Titan Tibial Nail (K003018), Zimmer Natural Nail System Tibial Nail (K082770) and Synthes (USA) Tibial Nail System EX (K040762) in regards to intended use, indications for use, technological characteristics (design features, material and performance) as well as operating principle.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- . Intramedullary nailing systems to provide a fracture fixation of the tibia,
- Nail and screw design (length, diameter, and shape), and .
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-
Nails, compression screw and end caps manufactured from titanium alloy (Ti6Al4V ELI) . as per ASTM F136.
The following technological difference exists between the subject and predicate devices: -
Hole configurations in proximal and distal part of nail. .
The difference has been addressed through performance testing which demonstrates that the subject device is as safe and effective as the predicate devices.
IMN Screws System
Device comparison demonstrated that the IMN Screws System is substantially equivalent to the previously cleared IMN Screws System (K172774) in regards to intended use, indications for use, technological characteristics (material and performance) as well as operating principle. The reference device (Titan Tibial Nail System, K003018) is suitable to provide technical information to help address the safety and effectiveness of a new technological characteristic. At a high level, the subject device and predicate device are based on the following same technological elements:
- Stabilization of intramedullary nail-bone construct, .
- . Used for proximally and distally locking of nail-bone construct,
- . Design (length and diameter), and
- . Manufactured from titanium alloy (Ti6A14V ELI) as per ASTM F136.
The following technological difference exists between the subject and predicate devices:
- . Thread design
The difference has been addressed through performance testing which demonstrates that the subject device is as safe and effective as the predicate devices.
IMN Instruments System
Device comparison demonstrated that the IMN Instruments System is substantially equivalent to the previously cleared IMN Instruments System (K172774) in regards to intended use, indications for use, technological characteristics as well as operating principle.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- Used for the implantation and extraction of intramedullary nail and screw, and .
- Compatibility with T2 Alpha nailing systems and IMN Screws System.
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T2 Alpha Femur Antegrade GT/PF Nailing System
Device comparison demonstrated that the T2 Alpha Femur Antegrade GT/PF Nailing System is substantially equivalent to the previously cleared T2 Alpha Femur Antegrade GT/PF Nailing System (K172774) in regards to intended use, technological characteristics (design features, material and performance) as well as operating principle.
At a high level, the subject device and predicate devices are based on the following same technological elements:
- . Intramedullary nailing systems to provide a fracture fixation of the long bone,
- Nail and screw design (length, diameter, and shape),
- . Nails, compression screw and end caps manufactured from titanium alloy (Ti6Al4V ELI) as per ASTM F136,
- Set screws are manufactured from titanium alloy (Ti6A14V ELI) as per ASTM F136 and . PEEK,
- . Hole configurations in proximal and distal part of nail, and
- Locking configurations. ●
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
T2 Alpha Tibia Nailing System
Non-clinical testing was performed for T2 Alpha Tibia Nailing System under worst case scenario to determine substantial equivalence. The following bench testing was conducted:
- . Testing of mechanical properties per ASTM F1264
- . Fatigue strength testing (proximal and distal)
- . Cut-out testing
- . Targeting accuracy testing
Testing demonstrated that T2 Alpha Tibia Nailing System is equivalent in mechanical performance to the predicate devices (K003018, K082770, and K040762).
Non-clinical testing has demonstrated that T2 Alpha Tibia Nailing System is MR Conditional.
Biocompatibility testing (ISO 10993-1, ISO 10993-5 and ISO 10993-18) was performed to evaluate the biological safety of T2 Alpha Tibia Nailing System according to FDA Guidance
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'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. Testing demonstrated that T2 Alpha Tibia Nailing System is biocompatible.
The Bacterial Endotoxin Testing demonstrated that the sterile implants of T2 Alpha Tibia Nailing System meet the specified endotoxin limit.
IMN Screws System
Non-clinical testing was performed for the advanced locking screws of IMN Screws System. The following bench testing was conducted:
- Testing of mechanical properties as per ASTM F543 ●
Testing demonstrated that the advanced locking screws are equivalent in mechanical performance to the predicate device (K172774) and reference device (K003018).
Non-clinical testing has demonstrated that the advanced locking screws are MR Conditional.
Biocompatibility assessment (ISO 10993-1) was performed according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. It has been demonstrated that the advanced locking screws are biocompatible. The Bacterial Endotoxin Testing demonstrated that the advanced locking screws meet the specified endotoxin limit.
IMN Instruments System
Non-clinical testing was performed for the surgical instruments of IMN Instruments System. The following bench testing was conducted:
- . Performance testing in cadaver lab, and
- . Compatibility evaluation
Testing demonstrated that the surgical instruments are equivalent in performance to the predicate device (K172774).
Biocompatibility testing (ISO 10993-1, ISO 10993-5, and ISO 10993-18) was performed according to FDA Guidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'. It has been demonstrated that the surgical instruments are biocompatible.
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T2 Alpha Femur Antegrade GT/PF Nailing System
Non-clinical testing was performed for T2 Alpha Femur Antegrade GT/PF Nailing System to determine substantial equivalence. Compatibility assessment demonstrated that T2 Alpha Femur Antegrade GT/PF Nailing System is suitable to be used with the advanced locking screws of IMN Screws System and the surgical instruments of IMN Instruments System as well as the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System.
IX. CLINICAL TESTING
T2 Alpha Tibia Nailing System
No clinical testing of the T2 Alpha Tibia Nailing System has been conducted.
IMN Screws System
No clinical testing of the IMN Screws System has been conducted.
IMN Instruments System
No clinical testing of the IMN Instruments System has been conducted.
T2 Alpha Femur Antegrade GT/PF Nailing System
No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted.
X. CONCLUSION
T2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System is substantially equivalent to the predicate devices (Titan Tibial Nail (K003018), Zimmer Natural Nail System Tibial Nail (K082770), and Synthes (USA) Tibial Nail System EX (K040762)) identified in this premarket notification.
IMN Screws System
The IMN Screws System is substantially equivalent to the predicate device (IMN Screws System (K172774) identified in this premarket notification.
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IMN Instruments System
The IMN Instruments System is substantially equivalent to the predicate device (IMN Instruments System (K172774)) identified in this premarket notification.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System is substantially equivalent to the predicate device (T2 Alpha Femur Antegrade GT/PF Nailing System (K172774)) identified in this premarket notification.