Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System

K233423 · Tyber Medical, LLC · HRS · Dec 21, 2023 · Orthopedic

Device Facts

• Record ID: K233423
• Device Name: Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System
• Applicant: Tyber Medical, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Dec 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. Mini-Frag System: The Tyber Medical Mini-Frag System is indicated for fixation of fractures, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.

Device Story

The Tyber Medical Anatomical Plating System is a line extension of the Mini-Frag System consisting of titanium plates (straight and T-plate) and 1.3mm locking/non-locking screws. The system is used by surgeons to bridge or stabilize bone fragments, facilitating healing in short bones and small fragments of the hand, wrist, foot, and ankle, as well as non-load bearing long bone fragments. The device is provided non-sterile and requires surgical implantation. It functions as a mechanical fixation appliance to maintain bone alignment during the healing process.

Clinical Evidence

No clinical testing was performed. Bench testing was conducted in conformance with ASTM F382 (metallic bone plates) and ASTM F543 (bone screws).

Technological Characteristics

Titanium bone plates and 1.3mm locking/non-locking screws. Mechanical fixation principle. Non-sterile. Testing performed per ASTM F382 and ASTM F543.

Indications for Use

Indicated for fixation of fractures, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone (hand, wrist, foot, ankle) and reduction/stabilization of non-load bearing long bone fragments. Contraindicated for spinal use.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• DePuy Synthes Variable Angle Locking Hand System (K150099)
• Tyber Medical, LLC. (K203817/K222465)

Submission Summary (Full Text)

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December 21, 2023

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 Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Tyber Medical, LLC. Lisa Boyle Director, Regulatory Affairs 83 South Commerce Way Suite 310 Bethlehem, Pennsylvania 18017

### Re: K233423

Trade/Device Name: Tyber Medical Anatomical Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 6, 2023 Received: October 10, 2023

### Dear Lisa Boyle:

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" (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).

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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 OS 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 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-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 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.

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

Sincerely,

## Shumaya Ali -S

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

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### Indications for Use

#### 510(k) Number (if known) K233423

#### Device Name

Tyber Medical Anatomical Plating System

#### Indications for Use (Describe)

Mini-Frag System:

The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The minifrag system is also intended for reduction and stabilization of non-load bearing long bone fragments.

The Tyber Medical Mini-frag System is not for Spinal Use.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| | 510(k) Summary | Prepared on: 2023-10-10 |
|--|----------------|-------------------------|
|--|----------------|-------------------------|

| Contact Details | 21 CFR 807.92(a)(1) |
|-----------------------------|------------------------------------------------------------------|
| Applicant Name | Tyber Medical, LLC. |
| Applicant Address | 83 South Commerce Way Suite 310 Bethlehem PA 18107 United States |
| Applicant Contact Telephone | 610-295-7984 |
| Applicant Contact | Mrs. Lisa Boyle |
| Applicant Contact Email | [e-mail] |

| Device Name | 21 CFR 807.92(a)(2) |
|---------------------|-----------------------------------------------------------------------------|
| Device Trade Name | Tyber Medical Anatomical Plating System |
| Common Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification Name | Plate, Fixation, Bone |
| Regulation Number | 888.3030 |
| Product Code | HRS |

| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|------------------------------------|---------------------|
|------------------------------------|---------------------|

| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-----------------|----------------------------------------------------------|--------------|
| K150099 | DePuy Synthes Variable Angle Locking Hand System | HRS |
| K203817/K222465 | Tyber Medical, LLC. | HRS |

## Device Description Summary

The Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System consists of titanium plates (straight and T-plate) and locking /non-lockingscrews (1.3mm) and are offered in a range of configurations to accommodate patient anatomy. The plates and screws are non-sterile.

21 CFR 807.92(a)(5)

# Intended Use/Indications for Use

The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing.

### Mini-Frag System:

The Tyber Medical Mini-Frag System is indicated for fixation of fractures, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.

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## Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications are similar in both the subject and predicate device(s).

## Technological Comparison

## 21 CFR 807.92(a)(6)

The subject device has the same technological characteristics (design, material, chemical composition and principle of operation) as the predicate device(s) identified above.

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

The mechanical testing for the subject devices were performed in conformance with the FDA currently-recognized version of ASTM F382 for metallic bone plates and ASTM F543 for bone screws.

No clinical testing was performed.

The Tyber Medical Anatomical Plating System (Mini-Frag Line Extension) is substantially equivalent to the predicate devices in material, basic design features, intended use, operation and performance. Any differences between the subject and predicate device are considered minor and do not raise different questions concerning safety, performance or effectiveness. From the evidence submitted in this 510(k), the subject devices are considered substantially equivalent to the predicate device.