Tyber Medical Trauma Screw

K252901 · Tyber Medical, LLC · HWC · Dec 31, 2025 · Orthopedic

Device Facts

• Record ID: K252901
• Device Name: Tyber Medical Trauma Screw
• Applicant: Tyber Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Dec 31, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use.

Device Story

Tyber Medical Trauma Screw; metallic bone fixation fastener; provides compression and fixation between adjacent bone segments. Available in thread diameters 1.5mm to 9.0mm; various thread configurations (full, long, short). Used by surgeons in clinical settings for orthopedic procedures. Device facilitates bone healing through mechanical stabilization. Includes associated washers and trays. Single-use only.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical comparative engineering analysis and biocompatibility evaluation leveraging previously cleared predicate devices.

Technological Characteristics

Metallic bone fixation fastener; thread diameters 1.5-9.0mm; full/long/short thread configurations. Materials and design equivalent to predicate devices. Intended for single use. Non-sterile/sterile status not specified; mechanical performance validated via comparative engineering analysis.

Indications for Use

Indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation in patients requiring bone stabilization appropriate for device size. Contraindicated for spinal use.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Tyber Medical Trauma Screw (K153575)
• Tyber Medical Trauma Screw (K192975)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 31, 2025

Tyber Medical LLC
Stacie Geffner-Atiya
Senior Regulatory Affairs Specialist
83 South Commerce Way, Suite 310
Bethlehem, Pennsylvania 18017

Re: K252901
Trade/Device Name: Tyber Medical Trauma Screw
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener
Regulatory Class: Class II
Product Code: HWC, HTN
Dated: December 23, 2025
Received: December 23, 2025

Dear Stacie Geffner-Atiya:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252901 - Stacie Geffner-Atiya
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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

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by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali

Shumaya Ali, M.P.H.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K252901 | ? |
| Please provide the device trade name(s). | | ? |
| Tyber Medical Trauma Screw | | |
| Please provide your Indications for Use below. | | ? |
| The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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| 510(k) #: K252901 | 510(k) Summary | Prepared on: 2025-12-31 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Tyber Medical LLC | |
| Applicant Address | 83 South Commerce Way, Suite 310 Bethlehem PA 18017 United States | |
| Applicant Contact Telephone | 201-923-0943 | |
| Applicant Contact | Ms. Stacie Geffner-Atiya | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Tyber Medical Trauma Screw | |
| Common Name | Bone Compression Screw | |
| Classification Name | Smooth or threaded metallic bone fixation fastener, Single/multiple component metallic bone fixation appliances and accessories. | |
| Regulation Number | 888.3040, 888.3030 | |
| Product Code(s) | HWC, HTN | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K153575 | Tyber Medical Trauma Screw | HWC |
| K192975 | Tyber Medical Trauma Screw | HWC |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| This traditional 510(k) submission adds configurations of the previously cleared Tyber Medical Trauma Screws under K192975 and K153575. The Tyber Medical Trauma Screw is designed to allow compression and fixation between two adjacent bone segments. The screw is available with thread diameters of 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, and 9.0mm. The screw is configured to have either full thread, long thread, or short thread. The multiple thread lengths come in various options which can assist to ensure fit for various bone sizes. General trauma screws are intended for compression and fixation of bone. This Submission also references Washers and Trays. The Trays are specific to the Tyber Medical Trauma Screws. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of bones appropriate for the size of the devices. Screws are intended for single use only. The Tyber Medical Trauma Screws are not for spinal use. | | |
| Indications for Use Comparison | | 21 CFR 807.92(a)(5) |
| The indications for use are similar for both the subject and predicate device(s). | | |

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Technological Comparison 21 CFR 807.92(a)(6)

A comparison of the subject devices and the predicate devices demonstrated that the Tyber Medical Trauma Screws, Washers and Trays are substantially equivalent to the previously cleared Tyber Medical Trauma Screw in regards to the intended use/indications for use, material, design, and operational principles.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Nonclinical Testing:
- Comparative engineering analysis demonstrated substantial equivalence to the predicate devices • • • •
(K153575, K192975) for the previously conducted mechanical testing.
- The biocompatibility evaluation of the subject device leveraged equivalence in materials and manufacturing to previously cleared implants (K153575, K192975).

Clinical Testing:
Not Applicable.

Conclusions:
The Tyber Medical Trauma Screws described in this submission have the similar indications for use, intended use, and the same materials as the predicate devices. The additional screws, washers and Trays (Caddy) have similar technological characteristics as the previously cleared predicate devices. The mechanical testing demonstrates the performance of the subject devices is equivalent to the predicate devices.