(106 days)
The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.
The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.
The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.
The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.
Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.
The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.
Key points from the document regarding "performance":
- Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
- Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.
Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.
In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.
FDA 510(k) Clearance Letter - K251400
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 20, 2025
Stryker GmbH
Jackie Perri
Staff Specialist, Regulatory Affairs
Bohnackerweg 1
Selzach, 2545
Switzerland
Re: K251400
Trade/Device Name: T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
Regulation Number: 21 CFR 888.3020
Regulation Name: Intramedullary fixation rod
Regulatory Class: Class II
Product Code: HSB, HWC
Dated: May 6, 2025
Received: July 21, 2025
Dear Jackie Perri:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K251400 - Jackie Perri Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K251400 - Jackie Perri Page 3
Sincerely,
Joseph P. Russell -S
Digitally signed by Joseph P. Russell -S
Date: 2025.08.20 13:17:25 -04'00'
for: Farzana Sharmin, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K251400
Device Name
T2 Alpha Humerus Nailing System;
IMN Screws System;
T2 Nailing System
Indications for Use (Describe)
The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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Office of Chief Information Officer
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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."
Page 5
Stryker GmbH T2 Alpha Humerus & IMN Screws
510(k) Summary
K251400 - Page 1 of 3
510(k) Summary
Proprietary name: T2 Alpha Humerus Nailing System
IMN Screws System
T2 Nailing System
Common name: Rod, fixation, intramedullary, and accessories
Screw, fixation, bone.
Regulation Number: 21 CFR 888.3020: Intramedullary fixation rod
21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Product Code(s): HSB
HWC
Device Class: Class II
Sponsor: Stryker GmbH
Bohnackerweg 1
2545 Selzach, Switzerland
Contact Person: Jackie Perri
Staff Specialist, Regulatory Affairs
Stryker
325 Corporate Drive
Mahwah, NJ 07430
jackie.perri@stryker.com
Date Prepared: May 06, 2025
Predicate Device: Primary Predicate: T2 Nailing System (K032523)
Additional Predicate: Tornier Humeral Nail and Tornier Long Humeral Nail (K230352)
IMN Screws System (K213328)
Device Description: The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.
The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the
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Stryker GmbH T2 Alpha Humerus & IMN Screws
510(k) Summary
K251400 - Page 2 of 3
intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.
The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.
Indications for Use: The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.
The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.
The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.
Comparison to predicate device:
The intended use and indications of the T2 Alpha Humerus devices are comparable to those of the predicate devices. The subject device is introducing new nail diameters (10, 11, and 12 mm). The subject device implants and the predicate device implants are both sterile and manufactured from titanium alloy. There is no change in the fundamental scientific technology shared by both the subject and predicate devices.
The intended use and indications of the IMN Screw devices are identical to those of the predicate device. The advanced locking screw lengths of the subject device are shorter in length (Ø4mm – 20, 22.5, and 25 mm). The subject device implants and the predicate device implants are both sterile and manufactured from titanium alloy. There is no change in the fundamental scientific technology shared by both the subject and predicate devices.
The intended use and indications of the T2 devices are identical to those of the predicate device. The new sterile washers are similar to the current washer previously cleared in this system, made of titanium alloy as per ASTM F136. The subject device implants and the predicate device implants are both sterile and manufactured from titanium alloy. There is no change in the fundamental scientific technology shared by both the subject and predicate devices.
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Stryker GmbH T2 Alpha Humerus & IMN Screws
510(k) Summary
K251400 - Page 3 of 3
Performance Data:
Non-Clinical Performance:
The T2 Alpha Humerus Nailing system implants are single-use, sterile devices. These implants are sterilized using gamma irradiation. The T2 Alpha Humerus Nailing system also comprises instruments that are provided non-sterile.
The IMN Screws are single-use sterile devices. These screws are sterilized using gamma irradiation.
Comparative assessment of the predicate and reference systems demonstrated substantial equivalence. The following factors were considered:
- Dynamic 4 Point Bending
- Static 4 Point Bending
- Static Torsional Stiffness
- Targeting Accuracy
- Insertion Torque and Pull-out Force
- MR assessment of magnetically induced displacement force per ASTM F2052, magnetically induced torque per ASTM F2213, RF-induced heating per ASTM F2182, and image artifacts per ASTM F2119.
- Packaging tests were performed according to ISO 11607-1 and ISO 11607-2.
- Biocompatibility evaluation according to ISO 10993-1.
Clinical Performance:
Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices.
Conclusion:
The subject devices have similar intended use and indications for use as the predicate device. The subject devices use the same operating principle, incorporate the same basic design and labeling, and are manufactured and sterilized using the same materials and processes as the predicate device.
The performance analyses demonstrate that:
- Any differences do not raise different questions of safety and effectiveness; and
- The subject devices are at least as safe and effective as the legally marketed predicate device.
§ 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.