(210 days)
Intended Use:
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing.
Indications for Use:
Mini-Frag System
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion of short bones and small fragments of bone including, but not limited to, 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.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:
- · Fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular
fractures, corrective osteotomies, non-unions, intra- and extra-articular and distal tibia fractures with a shaft extension, and malleolar fractures;
· In intra- and extra-articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
- In distal tibia/fibula long bones which include the metaphyseal region of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.
The Tyber Medical Anatomical Plating System consists of this submission, with a brief description of each system below:
-
Tyber Medical Mini-Frag System
-
Tyber Medical Ankle Fracture/Fusion System
Mini-Frag System
The Tyber Medical Mini-Frag System offers a variety of plating options for the fixation of bone fragments. The system incorporates plates of various lengths, thicknesses, and configurations. The system also incorporates standard (non-locking) and locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized trays are available specific to the Tyber Medical Mini-Frag System. Other ancillary instrumentation is available that is not specific to the Tyber Medical Mini-Frag System.
The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing.
The subject devices are offered non-sterile.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system incorporates plates of varying lengths, thicknesses, and configurations. The system also incorporates standard (non-locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized drill guides and trays are available specific to the Tyber Medical Ankle Fracture/Fusion System. Other ancillary instrumentation is not specific to the Tyber Medical Ankle Fracture/Fusion System.
The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing. The subject devices are offered non-sterile.
This FDA 510(k) summary describes a submission for the Tyber Medical Anatomical Plating System, which is a line extension to a previously cleared device. As such, the focus of the submission is to demonstrate substantial equivalence to the predicate devices rather than proving the device meets novel acceptance criteria through a new clinical study.
Therefore, the information typically found in a study proving acceptance criteria (like sample size, ground truth establishment, MRMC studies, etc.) is not applicable in this case. The submission relies on non-clinical testing and comparison to predicate devices.
Here's the breakdown based on your request, highlighting what is and isn't applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a line extension of an existing device, the "acceptance criteria" are primarily related to demonstrating equivalence to the predicate devices for the specified indications for use and technological characteristics. The performance is assessed through non-clinical testing.
| Acceptance Criterion (Demonstrating Equivalence) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Indications for Use: Must be the same as the predicate devices. | Met: The subject device (Tyber Medical Anatomical Plating System - line extension) has the same indications for use as the predicate device(s). This is explicitly stated in the "Indications for Use Comparison" section: "The indications for use are the same for both the subject and predicate device(s)." |
| Intended Use: Must be the same as the predicate devices. | Met: The subject device has the same intended use as the predicate device(s). |
| Material: Must be the same or comparable, with performance demonstrated if different. | Met: Plates are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type II surface treatment. Screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing. These materials are characteristic of orthopedic implants and are the same as or comparable to those in the predicate devices, as implied by the statement: "The Tyber Medical Anatomical Plating System are substantially equivalent to the previously cleared Tyber Medical Anatomical Plating System in regards to... material." |
| Design and Operational Principles: Must be similar to the predicate devices, with performance demonstrated if there are differences. | Met: The line extension includes "additional plates, trays, and instrumentation to the Tyber Medical Anatomical Plating System." The submission states: "The additional plates, screws, and accessory instrumentation have similar technological characteristics as the previously cleared predicate devices." It also states: "The additional plates and screws were compared using analysis to the predicate devices in K222465. The submitted comprehensive evaluation of the subject plates and screws shows that no new worst case is being introduced in this line extension." |
| Biocompatibility: (Implicitly met by using established materials) | Met: Although not explicitly detailed in the summary, titanium alloys (Ti-6Al-4V ELI) are well-established biocompatible materials for orthopedic implants. |
| Mechanical Performance: (Implicitly met by comparison and analysis to predicate devices) | Met: "The additional plates and screws were compared using analysis to the predicate devices in K222465. The submitted comprehensive evaluation of the subject plates and screws shows that no new worst case is being introduced in this line extension." This implies that the mechanical properties of the new components are within acceptable ranges established by the predicate device. |
| MR Safety: Must be characterized if the device could be exposed to MR environments. | Met: An MR assessment was performed in accordance with ASTM F2052 (magnetically induced displacement force), ASTM F2213 (magnetically induced torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifacts). The device is deemed MR Conditional. |
| Sterilization: (Implicitly addressed for non-sterile devices) | Met: The subject devices are "offered non-sterile," indicating the sterilization methods are not a new concern but rather an established state for the device. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission relies on non-clinical testing and comparison to predicate devices. There is no "test set" of patient data in the context of a clinical study for this 510(k) line extension. The "test set" would refer to the components (plates, screws) that underwent mechanical and MR testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no "ground truth" establishment by experts in the context of a clinical study for this 510(k) line extension. The ground truth for mechanical behavior comes from engineering principles, ASTM standards, and the performance characteristics of the legally marketed predicate devices.
4. Adjudication method for the test set
- Not Applicable. As there is no clinical "test set" involving human interpretation or subjective assessment, no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a metallic bone fixation system (plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a metallic bone fixation system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by reference to recognized ASTM International standards for mechanical testing and MR compatibility (e.g., ASTM F136 for material, ASTM F2052, F2213, F2182, F2119 for MR safety) and the established safety and effectiveness of the legally marketed predicate devices. The comprehensive evaluation showed "no new worst case is being introduced."
8. The sample size for the training set
- Not Applicable. This submission is for a medical device (bone plates and screws), not an AI algorithm. There is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no AI algorithm or training set, this question is not relevant.
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March 19, 2025
Tyber Medical, LLC Chelsea Smith Regulatory Affairs Manager 89 South Commerce Way. Suite 310 Bethlehem, Pennsylvania 18017
Re: K242486
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, HTN Dated: February 14, 2025 Received: February 14, 2025
Dear Chelsea Smith:
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 (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.
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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).
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 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.
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-device-advicecomprehensive-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-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-regulatory
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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).
Sincerely,
Thomas Mcnamara -S
For: Christopher Ferreira, M.S. 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
Submission Number (if known)
Device Name
Tyber Medical Anatomical Plating System
Indications for Use (Describe)
Intended Use:
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing.
Indications for Use:
Mini-Frag System
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion of short bones and small fragments of bone including, but not limited to, 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.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:
- · Fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular
fractures, corrective osteotomies, non-unions, intra- and extra-articular and distal tibia fractures with a shaft extension, and malleolar fractures;
· In intra- and extra-articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
- In distal tibia/fibula long bones which include the metaphyseal region of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion 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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510(k) #:
510(k) Summary
Prepared on: 2024-10-07
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Tyber Medical, LLC | |||
|---|---|---|---|---|
| Applicant Address | 89 South Commerce Way, Suite 310 Bethlehem PA 18017 United States | |||
| Applicant Contact Telephone | 267-671-7014 | |||
| Applicant Contact | Mrs. Chelsea Smith | |||
| Applicant Contact Email | csmith@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 andaccessories | |||
| Classification Name | Plate, Fixation, Bone | |||
| Regulation Number | 888.3030 | |||
| Product Code(s) | HRS, HWC, HTN | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K232652 | Tyber Medical Anatomical Plating System | HRS | ||
| K241218 | Tyber Medical Anatomical Plating System | HRS | ||
| K233423/K222465 | Tyber Medical Anatomical Plating System | HRS |
This traditional 510(k) is a line extension to the Tyber Medical Anatomical Plating System previously cleared under K232652, K241218, and K233423/K222465. The line extension includes additional plates, trays, and instrumentation to the Tyber Medical Anatomical Plating System.
The Tyber Medical Anatomical Plating System consists of this submission, with a brief description of each system below:
-
Tyber Medical Mini-Frag System
-
Tyber Medical Ankle Fracture/Fusion System
Mini-Frag System
The Tyber Medical Mini-Frag System offers a variety of plating options for the fixation of bone fragments. The system incorporates plates of various lengths, thicknesses, and configurations. The system also incorporates standard (non-locking) and locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized trays are available specific to the Tyber Medical Mini-Frag System. Other ancillary instrumentation is available that is not specific to the Tyber Medical Mini-Frag System.
The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing.
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The subject devices are offered non-sterile.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system incorporates plates of varying lengths, thicknesses, and configurations. The system also incorporates standard (non-locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized drill guides and trays are available specific to the Tyber Medical Ankle Fracture/Fusion System. Other ancillary instrumentation is not specific to the Tyber Medical Ankle Fracture/Fusion System.
The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing. The subject devices are offered non-sterile.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Intended Use:
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing.
Indications for Use:
Mini-Frag System
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, non-unions, malunions, replantations, and fusion of short bones and small fragments of bone including, but not limited to, 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.
Ankle Fracture/Fusion System The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:
· Fixation of fractures of the distal tibia including, but not imited to, ankle fractures, corrective osteotomies, nonunions, intra- and extra-articular and distal tibia fractures with a shaft extension, and malleolar fractures;
· In intra-and extra-articular fractures, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
- In distal tibia/fibula long bones which include the metaphyseal region of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.
Indications for Use Comparison
The indications for use are the same for both the subject and predicate device(s).
Technological Comparison
A comparison of the subject devices and the predicate devices demonstrated that the Tyber Medical Anatomical Plating System are substantially equivalent to the previously cleared Tyber Medical Anatomical Plating System 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:
The additional plates and screws were compared using analysis to the predicate devices in K222465. The submitted comprehensive evaluation of the subject plates and screws shows that no new worst case is being introduced in this line extension.
An MR assessment was perform for magnetically induced displacement force in accordance with ASTM F2052, magnetically induced torque in accordance with ASTM F2213, RF-induced heating in accordance with ASTM F2182, and image artifacts in accordance with ASTM F2119 demonstrating that The Tyber Medical Anatomical Plating System is MR Conditional.
Clinical Testing:
Image /page/5/Picture/25 description: The image contains the text "21 CFR 807.92(a)(6)". This text likely refers to a specific section of the Code of Federal Regulations (CFR), specifically Title 21, Part 807, Section 92, subsection (a), paragraph (6). The CFR is a codification of the general and permanent rules and regulations published in the Federal Register by the departments and agencies of the federal government.
21 CER 807.92(a)(5)
21 CFR 807.92(a)(5)
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Not Applicable.
Conclusions:
The Tyber Medical Anatomical Plating System described in this submission have the same indications for use, intended use, and materials as the predicate devices. The additional plates, screws, and accessory instrumentation have similar technological characteristics as the previously cleared predicate devices. The evidence submitted in this 510(k) demonstrates is substantially equivalent to the predicate devices.
§ 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.