(59 days)
No
The summary describes a mechanical fracture fixation system with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device, consisting of various nailing systems (T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System), is intended for "temporary stabilization of bone segments or fragments until bone consolidation has been achieved" or to "provide temporary stabilization of various types of fractures, malunions and nonunion". These are direct interventions to treat medical conditions (fractures, malunions, nonunion of bone), thereby classifying it as a therapeutic device. It aids in healing and provides internal fixation for bones.
No
The device is an intramedullary nailing system intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved as stated in the "# Intended Use / Indications for Use" section. It is a fixation device, not a diagnostic one.
No
The device description explicitly states that the submission encompasses multiple systems that include sterile implants (intramedullary nails, compression screw, end caps) and non-sterile instruments (targeting devices), which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the systems are for "temporary stabilization of bone segments or fragments until bone consolidation has been achieved" and "to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia." This describes a surgical implant used within the body to aid in bone healing.
- Device Description: The device description details "sterile implants (intramedullary nails in various diameter and sizes, compression screw, and end caps) as well as non-sterile instruments (targeting devices)." These are physical devices used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) 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
T2 Alpha Femur Retrograde Nailing System
The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
The indications for use of this internal fixation device include:
- · Open and closed femoral fractures
- · Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections ●
- . Supracondylar fractures, including those with intra-articular extension
- . Fractures involving osteopenic and osteoporotic bone
- Fractures distal to a total hip prosthesis
- Periprosthetic fractures ●
- Nonunions and malunions .
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.
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 Compression Screw Femur may also be used in conjunction with the T2 Alpha Femur Retrograde System.
T2 Tibial Nailing System
The T2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Open and closed tibial fractures ●
- Pseudoarthrosis and correction osteotomy ●
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Nonunion and malunion .
The Locking Screws may also be used in conjunction with the T2 Alpha Systems.
T2 Femoral Nail System
The T2 Femoral Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty ●
- . Fractures distal to hip joint
- Nonunions and malunions ●
The Condyle Nut and Condyle Screws may also be used in conjunction with the T2 Alpha Femur Retrograde System.
T2 Supracondylar Nail System
The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
The T2 Supracondylar Nail System is indicated for:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures including those with intra-articular extension ●
- . Fractures distal to total hip prosthesis
- . Nonunions and malunions
The End Cap may also be used in conjunction with the T2 Alpha Femur Retrograde System.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Retrograde Nailing System and update the Indications for Use for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System to include the compatibility of components with the T2 Alpha Femur Retrograde Nailing System.
This submission encompasses multiple systems (T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System) that have similar intended use and will be used together during the surgical procedure.
The T2 Alpha Femur Retrograde Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6A14V ELI) as per ASTM F136.
Additionally, the T2 Alpha Femur Retrograde Nailing System will be used with the existing locking screws most recently cleared in K200880 (Titan Tibial Nailing System), the locking screws and advanced locking screws of IMN Screws System (K191271), the condyle screws and nuts most recently cleared in K200880 (T2 Femoral Nail System), the Compression Screw Femur most recently cleared in K191271 (T2 Alpha Antegrade GT/PF Nailing System), and the end caps most recently cleared in K200880 (T2 Supracondylar Nail System), The T2 Alpha Femur Retrograde Nailing System is intended for use with IMN Screws System and IMN Instruments System.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System most recently cleared in K191271 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, Set Screws) are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The set screws are manufactured from titanium alloy (Ti6A14V 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 most recently cleared in K200880 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K200880), the Lag Screw Recon of T2 Recon System (K200880), the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System (K191271), the locking screws and advanced locking screws of IMN Screws System (K191271), the distal targeting device femur antegrade of IMN Instruments System (K191271) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices).
T2 Tibia Nailing System
The T2 Tibial Locking Nail is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and various end caps are manufactured from titanium alloy and are used with the nails. The T2 Tibial Locking Nail is available in two versions, each differing from the other only in diameter, length and number and orientation of screw holes.
T2 Femoral Nail System
The T2 Femoral Nail is a cylindrical, cannulated titanium allow tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
T2 Supracondylar Nail System
The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Tibia
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)
The following performance data was provided in support of the substantial equivalence determination.
Comparative mechanical testing to the predicate systems demonstrated substantial equivalence. The following tests were performed:
- . Testing of mechanical properties per ASTM F1264 (static stiffness, static strength, and dynamic fatigue strength)
- Fatigue strength testing ●
- . Cut-out testing
- Targeting accuracy testing (targeting stiffness testing) ●
Mechanical testing demonstrated that the T2 Alpha Femur Retrograde Nailing System is equivalent to the predicate devices (K200880, K101622).
MR assessments of magnetically-induced displacement force, magnetically-induced torque, RFinduced heating, and image artifacts demonstrate that the T2 Alpha Femur Retrograde Nailing System is MR conditional (ASTM F2052 for magnetically induced displacement force, ASTM F2213 for magnetically induced torque, ASTM F2182 for RF heating, and ASTM F2119 for image artifacts).
The Bacterial Endotoxin Testing demonstrated that the sterile implants of T2 Alpha Femur Retrograde Nailing System meet the specified endotoxin limit.
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.
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
February 26, 2021
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Stryker GmbH Jemin Dedania Associate Manager Regulatory Affairs 325 Corporate Drive Mahwah. New Jersey 07430
Re: K203819
Trade/Device Name: T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System. T2 Tibial Nailing System. T2 Femoral System. T2 Supracondylar Nail System
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 28, 2020 Received: December 29, 2020
Dear Jemin Dedania:
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
1
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 Michael Owens 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
2
510(k) Number (if known) K203819
Device Name
T2 Alpha Femur Retrograde Nailing System
Indications for Use (Describe)
The indications for use of this internal fixation device include:
- · Open and closed femoral fractures
- · Pseudoarthrosis and correction osteotomy
- · Pathologic fractures, impending pathologic fractures, and tumor resections
- · Supracondylar fractures, including those with intra-articular extension
- · Fractures involving osteopenic and osteoporotic bone
- · Fractures distal to a total hip prosthesis
- · Periprosthetic fractures
- Nonunions and malunions
| 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."
3
510(k) Number (if known) K203819
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
The Compression Screw Femur may also be used in conjunction with the T2 Alpha Femur Retrograde 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."
4
| 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.
510(k) Number (if known)
K203819
Device Name T2 Tibial Nailing System
Indications for Use (Describe)
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted or closed technique and can be statically, dynamically and compressed locked.
The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- · Open and closed tibial fractures
- · Pseudoarthrosis and correction osteotomy
- · Pathologic fractures, impending pathologic fractures, and tumor resections
- · Nonunion and malunion
The Locking Screws may also be used in conjunction with the T2 Alpha Systems.
Type of Use (Select one or both, as applicable)
XPrescription 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 aqency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMBnumber."
5
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) K203819
Device Name T2 Femoral Nail System
Indications for Use (Describe)
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following:
- · Open and closed femoral fractures
- · Pseudoarthrosis and correction osteotomy
- · Pathologic fractures, impending pathologic fractures, and tumor resections
- · Supracondylar fractures, including those with intra-articular extension
- · Ipsilateral femur fractures
- · Fractures proximal to a total knee arthroplasty
- · Fractures distal to hip joint
- Nonunions and malunions
The Condyle Nut and Condyle Screws may also be used in conjunction with the T2 Alpha Femur Retrograde System.
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 OMBnumber."
6
| 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.
510(k) Number (if known) K203819
Device Name
T2 Supracondylar Nail System
Indications for Use (Describe)
The T2 Supracondylar Nail System is indicated for:
- · Open and closed femoral fractures
- · Pseudoarthrosis and correction osteotomy
- · Pathologic fractures, impending pathologic fractures, and tumor resections
- · Supracondylar fractures including those with intra-articular extension
- · Fractures distal to a total hip prosthesis
- Nonunions and malunions
The End Cap may also be used in conjunction with the T2 Alpha Femur Retrograde System.
Type of Use (Select one or both, as applicable)
XPrescription 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 OMBnumber."
7
510(k) Summary
| I. SUBMITTER | |
|---|---|
| Sponsor: | Stryker GmbH |
| Bohnackerweg 1 | |
| 2545 Selzach / Switzerland | |
| Contact Person: | Jemin Dedania |
| Associate Manager, Regulatory Affairs | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: 201-831-6461 | |
| Fax: 201-831-6020 | |
| Date Prepared: | February 23, 2021 |
| II. DEVICE | |
| Name of Device: | T2 Alpha Femur Retrograde Nailing System |
| T2 Alpha Femur Antegrade GT/PF Nailing System | |
| T2 Tibial Nailing System | |
| T2 Femoral Nail System | |
| T2 Supracondylar Nail System | |
| Common Name: | T2 Alpha Femur Retrograde Nailing System |
| Rod, fixation, intramedullary and accessories | |
| T2 Alpha Femur Antegrade GT/PF Nailing System | |
| Rod, fixation, intramedullary and accessories | |
| T2 Tibial Nailing System | |
| Tibial Nail | |
| T2 Femoral Nail System | |
| Intramedullary Nail, Femoral Nail | |
| T2 Supracondylar Nail System | |
| Intramedullary Nail |
8
| Regulation Number / Name: | T2 Alpha Femur Retrograde Nailing System
21CFR 888.3020 (Intramedullary fixation rod) |
|---------------------------|------------------------------------------------------------------------------------------------------|
| | T2 Alpha Femur Antegrade GT/PF Nailing System
21CFR 888.3020 (Intramedullary fixation rod) |
| | T2 Tibial Nailing System
21CFR 888.3020 (Intramedullary fixation rod) |
| | T2 Femoral Nail System
21CFR 888.3020 (Intramedullary fixation rod) |
| | T2 Supracondylar Nail System
21CFR 888.3020 (Intramedullary fixation rod) |
| Product Code: | T2 Alpha Femur Retrograde Nailing System
HSB (Rod, fixation, intramedullary and accessories) |
| | T2 Alpha Femur Antegrade GT/PF Nailing System
HSB (Rod, fixation, intramedullary and accessories) |
| | T2 Tibial Nailing System
HSB (Rod, fixation, intramedullary and accessories) |
| | T2 Femoral Nail System
HSB (Rod, fixation, intramedullary and accessories) |
| | T2 Supracondylar Nail System
HSB (Rod, fixation, intramedullary and accessories) |
Regulatory Class:
Class II
III. PREDICATE DEVICE
| Primary Predicate: | T2 Supracondylar Nail System (K200880) |
|---|---|
| Additional Predicates: | T2 Femoral Nail (K200880) |
| Zimmer Natural Nail System Retrograde | |
| Femoral Nails (K101622) | |
| T2 GTN (K200880) | |
| T2 Tibial Nailing System (K200880) | |
| T2 Alpha Femur Antegrade GT/PF Nailing System | |
| (K191271) |
9
IV. DEVICE DESCRIPTION
This Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance to market the T2 Alpha Femur Retrograde Nailing System and update the Indications for Use for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System to include the compatibility of components with the T2 Alpha Femur Retrograde Nailing System.
This submission encompasses multiple systems (T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral Nail System, and T2 Supracondylar Nail System) that have similar intended use and will be used together during the surgical procedure.
The T2 Alpha Femur Retrograde Nailing System is a fracture fixation system and includes sterile implants (intramedullary nails in various diameter and sizes, compression screw, and end caps) as well as non-sterile instruments (targeting devices). The femoral nails, compression screw and end caps are made of titanium alloy (Ti6A14V ELI) as per ASTM F136.
Additionally, the T2 Alpha Femur Retrograde Nailing System will be used with the existing locking screws most recently cleared in K200880 (Titan Tibial Nailing System), the locking screws and advanced locking screws of IMN Screws System (K191271), the condyle screws and nuts most recently cleared in K200880 (T2 Femoral Nail System), the Compression Screw Femur most recently cleared in K191271 (T2 Alpha Antegrade GT/PF Nailing System), and the end caps most recently cleared in K200880 (T2 Supracondylar Nail System), The T2 Alpha Femur Retrograde Nailing System is intended for use with IMN Screws System and IMN Instruments System.
T2 Alpha Femur Antegrade GT/PF Nailing System
The T2 Alpha Femur Antegrade GT/PF Nailing System most recently cleared in K191271 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).
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The sterile implants (Femoral Nail GT, Femoral Nail PF, Compression Screw Femur, and End Cap GT/PF, Set Screws) are made of titanium alloy (Ti6A14V ELI) per ASTM F136. The set screws are manufactured from titanium alloy (Ti6A14V 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 most recently cleared in K200880 (Titan Tibial Nail) that have subsequently also received clearance for use in locking femoral nailing systems (K200880), the Lag Screw Recon of T2 Recon System (K200880), the End Cap Lower Extremity and the Nail Holding Screw Tibia / Femur PF of T2 Alpha Tibia Nailing System (K191271), the locking screws and advanced locking screws of IMN Screws System (K191271), the distal targeting device femur antegrade of IMN Instruments System (K191271) as well as the surgical instruments of IMN Instruments System and T2 Instruments System (510(k) exempt devices).
T2 Tibia Nailing System
The T2 Tibial Locking Nail is a cylindrical tube manufactured from titanium alloy and slightly bowed to accommodate the shape of the tibia. Locking screws, compression screws and various end caps are manufactured from titanium alloy and are used with the nails. The T2 Tibial Locking Nail is available in two versions, each differing from the other only in diameter, length and number and orientation of screw holes.
T2 Femoral Nail System
The T2 Femoral Nail is a cylindrical, cannulated titanium allow tube, slightly bowed to accommodate the shape of the femur. The T2 Femoral Nail may be inserted into the femoral canal using either a retrograde or antegrade surgical approach.
T2 Supracondylar Nail System
The T2 Supracondylar Nails are retrograde nails with a one-piece round profiled shaft design. The nails are cannulated and have a closed-section design with proximal rounded end. The T2 Supracondylar Nail is available in two versions: Short and Long. The T2 Supracondylar nails are
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available in lengths from 170 mm to 440 mm and in diameters from 9 mm to 14 mm. The T2 Supracondylar Nail System offers nails in varying lengths, a combination of locking screws, condyle screws, nuts and end caps.
V. INTENDED USE
T2 Alpha Femur Retrograde Nailing System
The T2 Alpha Femur Retrograde Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
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 Tibial Nailing System
The T2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
T2 Femoral Nail System
The T2 Femoral Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
T2 Supracondylar Nail System
The T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
VI. INDICATION FOR USE
T2 Alpha Femur Retrograde Nailing System
The indications for use of this internal fixation device include:
- . Open and closed femoral fractures
- . Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures and tumor resections ●
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- . Supracondylar fractures, including those with intra-articular extension
- . Fractures involving osteopenic and osteoporotic bone
- Fractures distal to a total hip prosthesis
- Periprosthetic fractures ●
- Nonunions and malunions .
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 ●
The Compression Screw Femur may also be used in conjunction with the T2 Alpha Femur Retrograde System.
T2 Tibial Nailing System
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Open and closed tibial fractures ●
- Pseudoarthrosis and correction osteotomy ●
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
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- Nonunion and malunion .
The Locking Screws may also be used in conjunction with the T2 Alpha Systems.
T2 Femoral Nail System
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- Supracondylar fractures, including those with intra-articular extension
- Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty ●
- . Fractures distal to hip joint
- Nonunions and malunions ●
The Condyle Nut and Condyle Screws may also be used in conjunction with the T2 Alpha Femur Retrograde System.
T2 Supracondylar Nail System
The T2 Supracondylar Nail System is indicated for:
- . Open and closed femoral fractures
- Pseudoarthrosis and correction osteotomy
- Pathologic fractures, impending pathologic fractures, and tumor resections ●
- Supracondylar fractures including those with intra-articular extension ●
- . Fractures distal to total hip prosthesis
- . Nonunions and malunions
The End Cap may also be used in conjunction with the T2 Alpha Femur Retrograde System.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Device comparison demonstrated that the T2 Alpha Femur Retrograde Nailing System, is substantially equivalent to the existing nails of the T2 Supracondylar Nail System (K200880), the
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T2 Femoral Nail (K200880), and the Zimmer Natural Nail System Retrograde Femoral Nails (K101622). The subject device and the predicate devices have the same 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 have the same technological characteristics, which include:
- Intramedullary nailing systems to provide a fracture fixation of the femur, ●
- 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. ●
VIII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Comparative mechanical testing to the predicate systems demonstrated substantial equivalence. The following tests were performed:
- . Testing of mechanical properties per ASTM F1264 (static stiffness, static strength, and dynamic fatigue strength)
- Fatigue strength testing ●
- . Cut-out testing
- Targeting accuracy testing (targeting stiffness testing) ●
Mechanical testing demonstrated that the T2 Alpha Femur Retrograde Nailing System is equivalent to the predicate devices (K200880, K101622).
MR assessments of magnetically-induced displacement force, magnetically-induced torque, RFinduced heating, and image artifacts demonstrate that the T2 Alpha Femur Retrograde Nailing System is MR conditional (ASTM F2052 for magnetically induced displacement force, ASTM F2213 for magnetically induced torque, ASTM F2182 for RF heating, and ASTM F2119 for image artifacts).
The Bacterial Endotoxin Testing demonstrated that the sterile implants of T2 Alpha Femur Retrograde Nailing System meet the specified endotoxin limit.
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IX. CLINICAL TESTING
No clinical testing of the T2 Alpha Femur Retrograde Nailing System has been conducted.
X. CONCLUSION
T2 Alpha Femur Retrograde Nailing System
The T2 Alpha Femur Retrograde Nailing System is substantially equivalent to the previously cleared T2 Supracondylar Nail System (K200880) primary predicate system and the T2 Femoral Nail (K200880), T2 GTN (K200880), and the Zimmer Natural Nail System Retrograde Femoral Nails (K101622) additional predicates.
T2 Supracondylar Nail System, T2 Femoral Nail System, and T2 Tibial Nailing System
The subject T2 Supracondylar Nail System, T2 Femoral Nail System, and T2 Tibial Nailing System are substantially equivalent to the predicate T2 Supracondylar Nail System, T2 Femoral Nail System, and T2 Tibial Nailing System (K200880) 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 (K191271)) identified in this premarket notification.