(72 days)
Not Found
No
The document describes a mechanical fixation system (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a system of plates and screws used for the fixation of fractures, osteotomies, malunions, replantations, and fusions, which are all therapeutic interventions aimed at treating medical conditions.
No
Explanation: The device is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions, which are treatment-oriented applications, not diagnostic ones.
No
The device description explicitly states it consists of titanium plates and screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Tyber Medical Mini-Frag System is described as a system of titanium plates and screws intended for the fixation of fractures, osteotomies, and fusions of bones. This is a surgical implant used directly on the patient's body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, the Tyber Medical Mini-Frag System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
short bones and small fragments of bone including the hand, wrist, foot, and ankle. non-load bearing long bone fragments.
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 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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 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 | lboyle@tybermed.com |
| 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.
4
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.