(29 days)
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
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.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The IMN Instruments System is intended to enable the implantation of intramedullary nail and screw.
A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.
The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).
The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).
The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct.
The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws.
This document describes a Special 510(k) Premarket Notification for modifications to existing intramedullary nailing systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, and IMN Instruments System). The submission's purpose is to demonstrate substantial equivalence to the previously cleared predicate device (K180436) for these modifications.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for modifications) | Reported Device Performance (supporting modifications) |
|---|---|
| Maintain packaging integrity and functionality for increased shelf-life. | Packaging testing performed using methods consistent with the predicate device. |
| No new worst-case scenarios identified through risk analysis. | Risk analysis (per DIN EN ISO 14971) demonstrated no new worst case. |
| Verification and validation methods for modifications are the same as for the original predicate device. | Same verification and validation methods applied as for the predicate (K180436). |
| Device remains as safe and effective as the predicate device. | Risk analysis demonstrated the subject device is as safe and effective as the predicate device. |
| Dimensional specifications meet established criteria. | Specification review and dimensional analysis performed using the same protocol as the original submission. |
| Acceptance criteria for dimensional changes are not altered from original device. | Acceptance criteria were not altered from those used for the original device. |
| No additional types of evaluation needed for dimensional changes. | No additional types of evaluation are needed for dimensional changes. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted." This indicates that there was no "test set" in the context of clinical performance evaluation. The data provenance supporting the modifications (shelf-life increase and dimensional changes) would be from in-house engineering and quality testing, likely conducted by Stryker Trauma GmbH in Schoenkirchen, Germany. These are likely retrospective data based on existing product infrastructure.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical testing was conducted and the performance data primarily relates to engineering and quality assessments for modifications, there is no mention of "experts" establishing ground truth in the context of a clinical test set. The validation would have been performed by qualified engineers and quality control personnel within Stryker Trauma GmbH.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication by experts was used for this Special 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The submission is for modifications to an existing device, and clinical efficacy was not under evaluation, nor was comparison with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable, as this device is a physical medical implant system, not a software algorithm or AI-powered device.
7. Type of Ground Truth Used:
The "ground truth" for this submission's modifications primarily relies on:
- Engineering specifications and data: For dimensional changes, ensuring the modified components still meet their intended design parameters.
- Packaging integrity and sterility data: For the shelf-life extension, ensuring the packaging maintains sterility and functionality over the new extended period.
- Risk analysis methodology: As per DIN EN ISO 14971, to confirm that the changes do not introduce new hazards or increase existing risks.
These are established through internal quality and engineering testing, not clinical outcomes, pathology, or expert consensus on patient data.
8. Sample Size for the Training Set:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, for the reasons stated above.
{0}------------------------------------------------
June 11, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Stryker Trauma GmbH Dr. Heike Gustke Staff Regulatory Affairs Specialist Prof-Kuentscher-Str. 1-5 24232 Schoenkirchen Germany
Re: K191271
Trade/Device Name: T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia 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: May 9, 2019 Received: May 13, 2019
Dear Dr. Heike 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known) K191271
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, 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
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 FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 1 of 4
{3}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
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)
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020. See PRA Statement below.
Page 2 of 4
{4}------------------------------------------------
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)
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
"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
Page 3 of 4
{5}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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
"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
Page 4 of 4
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
{6}------------------------------------------------
Special 510(k) Premarket Notification
| Section 9: 510(k) Summary | |
|---|---|
| I. SUBMITTER | |
| Sponsor: | Stryker Trauma GmbHProf.-Kuentscher-Str. 1-524232 Schoenkirchen / Germany |
| Contact Person: | Dr. Heike GustkeStaff Regulatory Affairs SpecialistProf.-Kuentscher-Str. 1-524232 Schoenkirchen / Germanyheike.gustke@stryker.comPhone: +49 4348 702 637Fax: +49 4348 702 8637 |
| Date Prepared: | April 15, 2019 |
| II. DEVICE | |
| Name of Device: | T2 Alpha Femur Antegrade GT/PF Nailing SystemT2 Alpha Tibia Nailing SystemIMN Screws SystemIMN Instruments System |
| Common Name: | T2 Alpha Femur Antegrade GT/PF Nailing SystemRod, fixation, intramedullary and accessoriesT2 Alpha Tibia Nailing SystemRod, fixation, intramedullary and accessoriesIMN Screws SystemScrew, fixation, boneIMN Instruments SystemRod, fixation, intramedullary and accessories |
| Regulation Number / Name: | T2 Alpha Femur Antegrade GT/PF Nailing System21CFR 888.3020 (Intramedullary fixation rod) |
| Stryker Trauma GmbH - T2 Alpha/IMN Systems | Special 510(k) Premarket Notification |
| T2 Alpha Tibia Nailing System | |
| 21CFR 888.3020 (Intramedullary fixation rod) | |
| IMN Screws System | |
| 21CFR 888.3040 (Smooth or threaded metallic bone fixationfastener) | |
| IMN Instruments System | |
| 21CFR 888.3020 (Intramedullary fixation rod) | |
| Product Code: | T2 Alpha Femur Antegrade GT/PF Nailing System |
| HSB (Rod, fixation, intramedullary and accessories) | |
| T2 Alpha Tibia Nailing System | |
| HSB (Rod, fixation, intramedullary and accessories) | |
| IMN Screws System | |
| HWC (Screw, fixation, bone) | |
| IMN Instruments System | |
| HSB (Rod, fixation, intramedullary and accessories) | |
| Regulatory Class: | Class II |
{7}------------------------------------------------
III. PREDICATE DEVICE
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System (K180436)
IV. DEVICE DESCRIPTION
A Special 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436. Modifications include an increase of shelf-life from 5 years to 10 years for the sterile implants and a change of dimensional specifications for the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF.
The intended use and indications for use of existing T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System previously cleared in K180436 remain unchanged.
This submission encompasses multiple systems (T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System and IMN Instruments System) that have similar intended use and will be used together during the surgical procedure.
{8}------------------------------------------------
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (femoral nails in various diameter and sizes, compression screw femur, set screws and end caps) as well as non-sterile instruments (targeting devices).
The sterile implants (Femoral Nail GT, Femoral Nail PF, Compression Screw Femur, and End Cap GT/PF) are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The set screws are manufactured from titanium alloy (Ti6Al4V ELI) per ASTM F136 and PEEK. The targeting devices are manufactured from stainless steel. PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers.
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), the Lag Screw Recon of T2 Recon System (K032898), the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System (K180436), the locking screws and advanced locking screws of IMN Screws System (K180436), the distal targeting device femur antegrade of IMN Instruments System (K180436) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices).
T2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System previously cleared in K180436 is a fracture fixation system and includes sterile implants (tibial nails in various diameter, compression screw tibia and end caps) as well as non-sterile instruments (targeting devices).
The sterile implants (Tibial Nail, Compression Screw Tibia, End Cap Tibia, and End Cap Lower Extremity) are made of titanium alloy (Ti6Al4V ELI) per ASTM F136. The adapters and nail holding screws will be manufactured from stainless steel. The Targeting Arm Tibia and Adjusting Device Tibia are made of stainless steel, PEEK unreinforced as well as PEEK with 30% and 50% carbon fibers. The Distal Targeting Arm Tibia is made of PEEK with 30% and 50% carbon fibers.
The T2 Alpha Tibia Nailing System will be used with the locking screws (K003018, Titan Tibial Nail), the locking screws and advanced locking screws of IMN Screws System (K180436), the surgical instruments of T2 Tibial Nailing System (K131365) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices). Further, the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System can be used with the T2 Alpha Femur Antegrade GT/PF Nailing System (K180436).
IMN Screws System
The IMN Screws System previously cleared in K180436 includes bone screws (locking screws and advanced locking screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. The screws are made of titanium alloy (Ti6Al4V ELI) per ASTM F136. The IMN Screws System is intended for use with T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System and IMN Instruments System.
{9}------------------------------------------------
IMN Instruments System
The IMN Instruments System includes the distal targeting device femur antegrade previously cleared in K180436. There are also associated surgical instruments (class I devices) that support the implantation and extraction of intramedullary nails and screws. The IMN Instruments System is intended for use with T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System and IMN Screws System.
V. INTENDED USE
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.
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 of intramedullary nail and screw.
VI. INDICATION FOR USE
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
{10}------------------------------------------------
Special 510(k) Premarket Notification
- Fractures proximal to a total knee arthroplastv ●
- Nonunions and malunions
- . Fractures involving osteopenic and osteoporotic bone
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.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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 (K180436) regarding 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 long bone, ●
- Nail and screw design (length, diameter, and shape), ●
- Nails, compression screw and end caps manufactured from titanium alloy (Ti6Al4V ELI) ● per ASTM F136.
- Set screws are manufactured from titanium alloy (Ti6Al4V ELI) per ASTM F136 and . PEEK,
{11}------------------------------------------------
- Hole configurations in proximal and distal part of nail, and .
- Locking configurations. .
T2 Alpha Tibia Nailing System
Device comparison demonstrated that the T2 Alpha Tibia Nailing System is substantially equivalent to the previously cleared T2 Alpha Tibia Nailing System (K180436) regarding 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 ●
- Nails, compression screw and end caps manufactured from titanium alloy (Ti6Al4V ELI) . per ASTM F136.
- Hole configurations in proximal and distal part of nail, and
- . Locking configurations.
IMN Screws System
Device comparison demonstrated that the IMN Screws System is substantially equivalent to the previously cleared IMN Screws System (K180436) regarding 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:
- . Stabilization of intramedullary nail-bone construct,
- . Used for proximally and distally locking of nail-bone construct,
- Design (length, diameter, thread design), and
- . Manufactured from titanium alloy (Ti6Al4V ELI) per ASTM F136.
IMN Instruments System
Device comparison demonstrated that the IMN Instruments System is substantially equivalent to the previously cleared IMN Instruments System (K180436) regarding 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. o
{12}------------------------------------------------
VIII. PERFORMANCE DATA
The submitter of this Special 510(k) is the manufacturer of the predicate device.
Increase of shelf-life from 5 years to 10 years for the sterile implants
The packaging testing was performed using methods consistent with the predicate device to ensure the packaging integrity and to support that the packaging preserves the functionality and safety of the device throughout its declared shelf-life.
A risk analysis was performed as per DIN EN ISO 14971 to assess the impact of the modification on the devices. The records of risk analysis process are retained in design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate device (K180436). The risk analysis demonstrated that the subject device is as safe and effective as the predicate device.
Change of dimensional specifications of the Advanced Locking Screw, Targeting Arm Femur GT and Targeting Arm Femur PF
The specification review and dimensional analysis were performed using the same protocol as the original submission for collecting and assessing the data. The acceptance criteria were not altered from those used for the original device. No additional types of evaluation are needed.
A risk analysis was performed as per DIN EN ISO 14971 to assess the impact of the modification on the devices. The records of risk analysis process are retained in design history file. The evaluation demonstrated that the subject device did not present a new worst case and that the same verification and validation methods were applied to the subject device in comparison to the previously cleared predicate device (K180436). The risk analysis demonstrated that the subject device is as safe and effective as the predicate device.
IX. CLINICAL TESTING
T2 Alpha Femur Antegrade GT/PF Nailing System
No clinical testing of the T2 Alpha Femur Antegrade GT/PF Nailing System has been conducted.
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.
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Special 510(k) Premarket Notification
X. CONCLUSION
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 (K180436)) identified in this premarket notification.
T2 Alpha Tibia Nailing System
The T2 Alpha Tibia Nailing System is substantially equivalent to the predicate device (T2 Alpha Tibia Nailing System (K180436)) identified in this premarket notification.
IMN Screws System
The IMN Screws System is substantially equivalent to the predicate device (IMN Screws System (K180436) identified in this premarket notification.
IMN Instruments System
The IMN Instruments System is substantially equivalent to the predicate device (IMN Instruments System (K180436)) identified in this premarket notification.
§ 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.