(227 days)
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing and is composed of the following bone plate categories:
Mini-frag/Small Bone System
The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments including, but are not limited to, the hand, wrist, foot and ankle.
The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use.
Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, osteotomies, nonunions, malunions, reconstruction of small, medium and large bones, revision surgeries and replantations in an adult patient.
The Tyber Medical Foot System is not for Spinal Use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is intended for osteotomies and non-unions, fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula.
The Tyber Medical Long Bone Fracture System is not for Spinal Use.
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
2). 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;
3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.
The Tyber Medical Anatomical Plating System consists of the following categories:
- Mini-frag/Small Bone System
- Foot System
- Long Bone Fracture System
- Ankle Fracture/Fusion System
Mini-frag/Small Bone System: Offers a variety of plates for fixation of bone fragments, including standard and locking compression plates and screws of varying lengths, thicknesses, and configurations. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary instrumentation is available. Offered sterile and non-sterile.
Foot System: Consists of a variety of plates with shapes and sizes designed for internal fixation of small bone fragments of the implants are designed to provide highly anatomic and versatile options for an array of fusions and stabilizations of small bones in the feet. Plates are available in various lengths, with straight, right and left configurations and numerous plate types. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.
Long Bone Fracture System: Consists of a straight low contact locking plate and a 1/3 locking tubular plate. Incorporates both Cortical locking and standard Cortical Non-locking screws. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.
Ankle Fracture/Fusion System: Designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. Composed of various locking plate types. Incorporates both Cortical Locking Screws and standard Cortical Non-locking Screws in various lengths. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.
The provided text is a 510(k) Pre-market Notification for the Tyber Medical Anatomical Plating System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and indications for use, rather than presenting clinical study results for specific performance metrics of an AI/ML powered device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not specify performance criteria in the context of an AI/ML study, nor does it report specific device performance metrics in comparison to such criteria.
- Sample size used for the test set and the data provenance: There is no mention of a test set for an AI/ML model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no AI/ML test set is described.
- Adjudication method for the test set: Not applicable.
- 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: This is not an AI-powered device, so such a study would not be presented here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
However, I can extract information related to non-clinical testing and the basis for proving substantial equivalence to acceptance criteria, which, in this context, are represented by the performance of predicate devices.
Acceptance Criteria and Study for the Tyber Medical Anatomical Plating System:
1. Table of Acceptance Criteria and the Reported Device Performance:
The "acceptance criteria" for this type of device (metallic bone fixation appliances) are primarily demonstrated through substantial equivalence to legally marketed predicate devices, meaning the new device performs similarly and is as safe and effective. The performance is assessed through non-clinical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from Nonclinical Testing) |
|---|---|
| Mechanical Performance and Fatigue Endurance (for Plates): Must demonstrate comparable mechanical properties to predicate devices according to established standards. | Testing according to ASTM F382-17, “Standard Specification and Test Method for Metallic Bone Plates,” has been completed on identified worst-case plates. The results demonstrate that the system (Tyber Medical Anatomical Plating System) is substantially equivalent to legally marketed predicates in terms of mechanical performance and fatigue endurance. |
| Mechanical Performance (for Screws): Must be comparable to predicate devices. | The proposed bone screws are comparable to the previously cleared Tyber Medical Trauma Screw System (K133842). These screws have identical major and minor thread diameters and thread profiles per size. No new worst-case scenario has been created, implying equivalent performance to previously cleared screws. |
| Biocompatibility: Materials must be biocompatible and safe for implantation. | Implicitly met by using standard materials (Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L)) that are well-established in similar predicate devices. The document states "similar in design, material, technological characteristics and indications when compared to the predicate devices." |
| Sterility: Must meet sterility requirements if offered sterile. | The system is offered "both sterile and non-sterile for single-use," which implies that appropriate sterilization validation would have been performed for the sterile versions, though details are not provided in this summary. This is a common requirement for medical devices and would be considered part of the overall acceptance criteria for safety and performance. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical count of plates or screws tested. The testing involved "identified worst-case plates" and screws. This implies a representative selection, but not a large "sample size" in the context of a clinical study or AI/ML performance evaluation.
- Data Provenance: The "study" is nonclinical (laboratory bench testing) conducted according to established ASTM standards. The provenance is internal testing performed by or for Tyber Medical LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a nonclinical bench testing submission for a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method for the test set:
This information is not applicable as this is a nonclinical bench testing submission.
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:
No – This section clearly states "Clinical Test Summary: n/a". The device is a bone plating system, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No – This is not an AI/ML device.
7. The type of ground truth used:
For mechanical testing, the "ground truth" is established by the specified parameters and methodologies within the ASTM F382-17 standard and the physical properties of the materials and designs under test. The comparison is against the performance of predicate devices as a benchmark for substantial equivalence.
8. The sample size for the training set:
Not applicable – This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable – This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the date August 13, 2021. The text is written in a simple, sans-serif font. The date is presented in a clear and straightforward manner. The text is horizontally aligned and evenly spaced.
Tyber Medical LLC Mark F. Schenk Vice President of Regulatory & Quality 83 South Commerce Way Suite 310 Bethlehem. Pennsylvania 18017
Re: K203817
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: July 13, 2021 Received: July 14, 2021
Dear Mark F. Schenk:
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 (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 located 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.
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K203817
Device Name
Tyber Medical Anatomical Plating System
Indications for Use (Describe)
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing and is composed of the following bone plate categories:
Mini-frag/Small Bone System
The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments including, but are not limited to, the hand, wrist, foot and ankle.
The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use.
Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, osteotomies, nonunions, malunions, reconstruction of small, medium and large bones, revision surgeries and replantations in an adult patient.
The Tyber Medical Foot System is not for Spinal Use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is intended for osteotomies and non-unions, fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula.
The Tyber Medical Long Bone Fracture System is not for Spinal Use.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K203817
Device Name Tyber Medical Anatomical Plating System
Indications for Use (Describe) (Continued)
Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). 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;
3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion Plating 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
{4}------------------------------------------------
Traditional 510(k) Summary
as required by section 807.92(c).
Tyber Medical Anatomical Plating System
K203817
| Submitted | 8/13/21 |
|---|---|
| Submitter: | Tyber Medical LLC83 South Commerce Way, Suite 310Bethlehem, PA 18017 |
| Contact Person | Mark SchenkV.P. RegulatoryPhone: 610-849-0645Email: mschenk@tybermed.com |
| Trade Name | Tyber Medical Anatomical Plating System |
| Common Name | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Device Class | Class II |
| Classification Nameand Number | Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030) - PrimarySmooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Classification Panel: | Orthopedic |
| Product Code | HRS, HWC |
Predicate Devices
| System | Primary Predicate | Additional Predicates |
|---|---|---|
| Mini-frag/Small Bone | Tyber Medical Anatomical Plating System (K193222) | ORTHOLOC® 3Di Small Bones Plating System (K163039) |
| Foot System | Tyber Medical Anatomical Plating System (K193222) | ORTHOLOC® 3Di Foot Plating Reconstruction System (K152974) |
| Long Bone Fracture System | Tyber Medical Anatomical Plating System (K193222) | AxSOS 3 Ti; Stryker Plating System (K162439) |
| Ankle Fracture/Fusion System | Tyber Medical Anatomical Plating System (K193222) | Baby Gorilla/Gorilla Plating System (190365) |
| System | Primary Predicate | Reference Predicates |
|---|---|---|
| Screws | Tyber Medical Anatomical Plating System (K193222) | Tyber Medical Trauma Screw System (K133842) |
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K203817 Page 2 of 5
Device Description
The Tyber Medical Anatomical Plating System consists of the following categories:
-
- Mini-frag/Small Bone System
-
- Foot System
-
- Long Bone Fracture System
-
- Ankle Fracture/Fusion System
A brief and concise description of each system is as follows:
Mini-frag/Small Bone System
The Tyber Medical Mini-frag/Small Bone System offers a variety of plates for fixation of bone fragments. The system incorporates a series of standard and locking compression plates and screws of varying lengths, thicknesses, and configurations including 1). Straight Fracture Plates, 2). T-shape Fracture Plates, 3). Y-shape Fracture Plates, 4). L-shape Fracture Plates, 5). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8). Oblique Fracture Compression Plates, 9). Double Y-Shape Plates, 10). Zig-Zag Plates, 11). Partial Zig-Zag Plates, 12). Mesh Plates
The System will incorporate both Cortical Locking Screws and standard Cortical Non-Locking Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6AI-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary instrumentation is available with the system. The Tyber Medical Minifrag/Small Bone System is offered both sterile and non-sterile for single-use.
Foot System
The Tyber Medical Foot System consists of a variety of plates with shapes and sizes designed for internal fixation of small bone fragments of the implants are designed to provide highly anatomic and versatile options for an array of fusions and stabilizations of small bones in the feet. The plates are available in various lengths, with straight, right and left configurations. Plate types consist of 1). TMT-I Fusion Plates, 2). Open Wedge Plates, 3). Navicular Plates, 4). Cuboid Plates, 5). Lateral Talar Neck Plates, 7). 5th Metatarsal Jones Fracture Plates, 8). 5th Metatarsal Fracture Compression Plates, 9). 5th Metatarsal Avulsion Fracture Plates, 10). Medial Talar Neck Plates, 11). Distal Medial Column Plates, 12). ORIF Calcaneal Plates, 13). ORIF Standard Calcaneal Plates, 14). Rectangular Plates, 15). X-Plates, 16). Cotton Plates, 17). Dwyer Plates, 18). MTP Fusion Plates, 19). MTP Fusion Revision Plates, 20). Stepped Lapidus Plates, 21). Plantar TMT Plates, 22). Medial Column Plates, 23). Evans Osteotomy Plates, 24). TMT-I Medial Fusion Plates, 25). Sinus Tarsi Plates, 26). 1st 200 Ray Lisfranc Joint Plates, 27). 200 and 30 Ray Lisfranc Joint Plates, 28). Perimeter Calcaneus Plates, 29). Navicular Cuneiform Plates, 30). Talonavicular Plates.
{6}------------------------------------------------
The system will incorporate both Cortical locking and standard Cortical Non-locking screws. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6AI-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Foot System is offered both sterile and non-sterile for single-use.
Long Bone Fracture System
The Tyber Medical Long Bone Fracture System consists of a straight low contact locking plate and a 1/3 locking tubular plate. The system will incorporate both Cortical locking and standard Cortical Non-locking screws. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Long Bone Fracture System is offered both sterile and non-sterile for single-use.
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 is composed of various locking plate types which include 1). Posterior Tibia Plate, 2). Fibula Plate, 3). Medial Tibia Plate, 5). Anterolateral Tibia Plate, 6). Medial Malleolus Hook Plate, 7). Medial Malleolus Plate, 8). Fibula Hook Plate, Straight, 9). Fibula Hook Plate, Anatomic, 10). Anterior Tibia Plate, 11). Anterior TT Plate, 12). Anterolateral TT Plate, 13). Lateral TT Plate, 14). Lateral TTC Plate, 15). Posterior TTC Plate, 16). Posterolateral Tibia Plate, 17). Posteromedial Tibia Plate, 18). Trimalleolar Plate, 19). Posterior Fibular Plate.
The System will incorporate both Cortical Locking Screws and standard Cortical Non-locking Screws in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6AI-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile for single-use.
| Intended Use | The intended use of the Tyber Medical Anatomical Plating System is todraw two or more aligned bone fragments together to facilitate healing. |
|---|---|
| Indications for Use | Mini-frag/Small Bone SystemThe Tyber Medical Mini-Frag/Small Bone System is intended for fixationof fractures, osteotomies, nonunions, replantations, and fusions of smallbones and small bone fragments including, but are not limited to, thehand, wrist, foot and ankle. |
| The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use. | |
| Foot System | |
| The Tyber Medical Foot System is Indicated for Use in fixation of smallbones and small bone fragments in the foot (Phalanges andMetatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus andCalcaneus) for stabilization of fractures, joint fusions, osteotomies,nonunions, malunions, reconstruction of small, medium and largebones, revision surgeries and replantations in an adult patient.The Tyber Medical Foot System is not for Spinal Use. | |
| Long Bone Fracture System | |
| The Tyber Medical Long Bone Fracture System is intended forosteotomies and non-unions, fixation of fractures of the clavicle,scapula, olecranon, humerus, radius, ulna, fibula.The Tyber Medical Long Bone Fracture System is not for Spinal Use. | |
| Ankle Fracture/Fusion System | |
| The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:1). Fixation of fractures of the distal tibia included, but not limited to,ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaftextension, and malleolar fractures;2). In intra- and extra articular fractures, osteotomies, medial malleolarfractures and non-unions of the metaphyseal and diaphyseal region ofthe distal fibula, and calcaneus;3). In distal tibia/fibula long bones which include the metaphyseal anddiaphyseal regions of the tibia and fibula in the ankle.The Tyber Medical Ankle Fracture/Fusion Plating System is not for SpinaUse. |
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| Statement ofTechnologicalComparison andFundamental ScientificTechnology | The Tyber Medical Anatomical Plating System is similar indesign, material, technological characteristics andindications when compared to the predicate devices. |
|---|---|
| ----------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Nonclinical TestingSummary | Testing according to ASTM F382-17, “Standard Specificationand Test Method for Metallic Bone Plates,” has beencompleted on the identified worst-case plates to characterizethe mechanical performance and fatigue endurance of the |
|---|---|
| -------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{8}------------------------------------------------
| Tyber Medical Anatomical Plating System. Results of the testing demonstrate that the system is substantially equivalent to legally marketed predicates. | |
|---|---|
| The proposed bone screws are comparable to the previously cleared Tyber Medical Trauma Screws. These screws have identical major and minor thread diameters and thread profiles per size. No new worst case has been created. | |
| Clinical Test Summary | n/a |
| Conclusion | The Tyber Medical Anatomical Plating System is similar in design, material, technological characteristics, and indications when compared 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.