(90 days)
Not Found
No
The 510(k) summary describes a traditional bone plating system and does not mention any AI or ML components or functionalities.
Yes
The device is a plating system (bone plates, screws, and instruments) indicated for fixation of fractures, fusions, non-unions, malunions, or osteotomies of the radius, ulna, and hand, which are therapeutic interventions.
No
Explanation: The device is a plating system designed to fix fractures, fusions, non-unions, malunions, or osteotomies of bones. It describes a treatment or fixation method, not a diagnostic one.
No
The device description explicitly states that the system consists of "various bone plates, screws, and instruments," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the fixation of fractures, fusions, non-unions, malunions, or osteotomies of the radius, ulna, and hand. This describes a surgical implant used within the body to stabilize bones.
- Device Description: The device consists of bone plates, screws, and instruments. These are physical components used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used directly on the body.
N/A
Intended Use / Indications for Use
The Tyber Medical Distal Radius Plating System includes the Tyber Medical Distal Radius, Forearm, and Fragment-Specific plates, which are indicated for fixation for fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The Tyber Medical Distal Radius System is not for Spinal Use.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Tyber Medical Distal Radius Plating System presented in this 510(k) submission consist of various bone plates, screws, and instruments.
The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.
All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L).
A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system.
The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius, ulna, and hand.
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)
No clinical testing was performed.
The mechanical testing for the subject devices were performance with the FDA currently recognized version of ASTM F382 for metallic bone plates and ASTM F543 for metallic bone screws in the system, mechanical testing was unnecessary as the minor differences from the predicate screws did not create a new worst-case screw design (major diameter, minor diameter, and shaft thread shape are the same). An engineering analysis showed that the subject plate improved resistance to bending due to the higher moment of ine Tyber Medical Distal Radius System 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.
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.
K203871, K142906, K193222/K222465
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
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December 4, 2023
Tyber Medical, LLC. Lisa Boyle Director, Regulatory Affairs 83 South Commerce Way Suite 310 Bethlehem, Pennsylvania 18036
Re: K232693
Trade/Device Name: Tyber Medical Distal Radius 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: August 31, 2023 Received: September 5, 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"
1
(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 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) K232693
Tyber Medical Distal Radius Plating System
Indications for Use (Describe)
The Tyber Medical Distal Radius Plating System includes the Tyber Medical Distal Radius, Forearm, and Fragment-Specific plates, which are indicated for fixation for fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The Tyber Medical Distal Radius 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: 2023-11-27
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 | 6102957984 | |
| Applicant Contact | Mrs. Lisa Boyle | |
| Applicant Contact Email | lboyle@tybermed.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Tyber Medical Distal Radius Plating System | |
| Common Name | Plate, Fixation, Bone; Screw, Fixation, Bone | |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories - Primary | |
| Smooth or threaded metallic bone fixation fastener | ||
| Regulation Number | 888.3030 (primary), 888.3040 (secondary) | |
| Product Code | HRS/HWC | |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K203871 | Tyber Medical Anatomical Plating System | HRS |
| K142906 | Medartis AG APTUS Wrist 2.5mm System | HRS |
| K193222/K222465 | Tyber Medical Anatomical Plating System | HRS |
| Device Description Summary 21 CFR 807.92(a)(4) | ||
| The Tyber Medical Distal Radius Plating System presented in this 510(k) submission consist of various bone plates, screws, and instruments. | ||
| Distal Radius Plating System | ||
| The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand. |
The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.
All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L).
A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system.
The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.
4
Intended Use/Indications for Use
Tyber Medical Distal Radius Plating System
The Tyber Medical Distal Radius Plating System includes the Tyber Medical Distal Radius, Forearm, and Fragment-Specific plates, which are indicated for fixation for fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.
The Tyber Medical Distal Radius System is not for Spinal Use.
Indications for Use Comparison
The indications are similar in both the subject and predicate device(s).
Technological Comparison
The subject device has the same technological characteristics (design, material 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)
No clinical testing was performed.
The mechanical testing for the subject devices were performance with the FDA currently recognized version of ASTM F382 for metallic bone plates and ASTM F543 for metallic bone screws in the system, mechanical testing was unnecessary as the minor differences from the predicate screws did not create a new worst-case screw design (major diameter, minor diameter, and shaft thread shape are the same). An engineering analysis showed that the subject plate improved resistance to bending due to the higher moment of ine Tyber Medical Distal Radius System 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.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)