(30 days)
Not Found
No
The device description focuses on the materials, sizes, and mechanical components of bone plates, screws, and instruments. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes
The device is described as "Anatomical Plating System" intended to "bridge or otherwise stabilize bone fragments to facilitate healing" for fractures, osteotomies, nonunions, malunions, and fusions, which directly addresses medical conditions and aims to restore normal bodily function, classifying it as a therapeutic device.
No
This device is a plating system (screws, plates, washers) used to stabilize bone fragments, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of various bone plates, locking screws, washers, and instruments, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is a system of bone plates, screws, and instruments used for the surgical fixation of bone fractures, osteotomies, nonunions, malunions, replantations, and fusions. This is a surgical implant/device, not something used to test specimens outside the body.
The device is intended for direct surgical intervention on the human body to stabilize bone, which is the opposite of an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
Intended Use:
The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Fraq System and Ankle Fracture/ Fusion System with the following indications:
Indications for Use:
Mini-fraq System
The Tyber Medical Mini-Fraq System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions 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
Tyber Medical Ankle Fracture/Fusion System is indicated for Use in:
Fixation of fractures of the distal tibia included, 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 nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
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.
Product codes
HRS, HWC, HTN
Device Description
Note: The only subject devices of this Special 510(k) submission are the optional bone screw Washers are only to be used with the non-locking screws in the Mini-fraq and Ankle Fracture/Fusion Systems.
Tyber Medical Anatomical Plating System Information
The systems presented in this Special 510(k) submission consist of various bone plates, locking screws, washers, and instruments. The Tyber Medical Anatomical Plating System consists of the following categories:
1.Mini-frag System
2.Ankle Fracture/Fusion System
A description of each system is provided below:
Mini-frag/Small Bone System
The Tyber Medical Mini-frag System is designed to address a variety of indications for short bones and sincluding, but not limited to, the hand, wrist, foot and ankle.
The System will incorporate both Locking Screws and standard non-locking Screws in 2.0, 2.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.0mm sizes. All locking screws can be placed on-axis with the internal plate threads or up to 15 degrees off axis in any direction.
All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional bone screw washers 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 instruments are not specific to the system. The Tyber Medical Mini-frag/Small Bone System is offered both sterile and 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 will incorporate both locking Screws and standard non-locking screws in 2.7, 3.0, 3.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.7, 3.5, and 4.0mm sizes. All locking screws can be placed onaxis with the internal plate threads or up to 15 degrees off axis in any direction.
All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional screw washers 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 instruments are not specific to the system.
The Tyber Medical Ankle Fracture/Fusion 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
hand, wrist, foot, ankle, distal tibia, distal fibula, calcaneus
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)
All design contol activities, including verification, and other testing, demonstrates that adding optional screw Washers to the Tyber Medical Anatomical Plating System does not raise any questions of safety or performance and is substantially equivalent to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
May 31, 2024
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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Tyber Medical, LLC Nicole Merlini Regulatory Affairs Specialist 83 S Commerce Way Suite 310 Bethlehem, Pennsylvania 18017
Re: K241218
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: April 30, 2024 Received: May 1, 2024
Dear Nicole Merlini:
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 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.
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 mediation-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,
Tejen D. Soni -S
For
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
Submission Number (if known)
Device Name
Tyber Medical Anatomical Plating System
Indications for Use (Describe)
Intended Use:
The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Fraq System and Ankle Fracture/ Fusion System with the following indications:
Indications for Use:
Mini-fraq System
The Tyber Medical Mini-Fraq System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions 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
Tyber Medical Ankle Fracture/Fusion System is indicated for Use in:
Fixation of fractures of the distal tibia included, 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 nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
- 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)
The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Prepared on: 05/29/2024 Contact Details 21 CFR 807.92(a)(1) Tyber Medical, LLC Applicant Name 83 S Commerce Way Suite 310 Bethlehem PA 18017 United States Applicant Address 484-274-4471 Applicant Contact Telephone Mrs. Nicole Merlini Applicant Contact nmerlini@tybermed.com Applicant Contact Email Device Name 21 CFR 807.92(a)(2) Tyber Medical Anatomical Plating System Device Trade Name Single/multiple component metallic bone fixation appliances and Common Name accessories Plate, Fixation, Bone Classification Name 888.3030, 888.3040 Regulation Number HRS, HTN, HWC Product Code(s)
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
21 CFR 807.92(a)(4
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K153575 | Tyber Medical Trauma Screw System | HWC |
| K232652 | Tyber Medical Anatomical Plating System | HRS |
Device Description Summary
Note: The only subject devices of this Special 510(k) submission are the optional bone screw Washers are only to be used with the non-locking screws in the Mini-fraq and Ankle Fracture/Fusion Systems.
Tyber Medical Anatomical Plating System Information
The systems presented in this Special 510(k) submission consist of various bone plates, locking screws, washers, and instruments. The Tyber Medical Anatomical Plating System consists of the following categories:
1.Mini-frag System
2.Ankle Fracture/Fusion System
A description of each system is provided below:
Mini-frag/Small Bone System
The Tyber Medical Mini-frag System is designed to address a variety of indications for short bones and sincluding, but not limited to, the hand, wrist, foot and ankle.
The System will incorporate both Locking Screws and standard non-locking Screws in 2.0, 2.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.0mm sizes. All locking screws can be placed on-axis with the internal plate threads or up to 15 degrees off axis in any direction.
4
All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional bone screw washers 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 instruments are not specific to the system. The Tyber Medical Mini-frag/Small Bone System is offered both sterile and 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 will incorporate both locking Screws and standard non-locking screws in 2.7, 3.0, 3.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.7, 3.5, and 4.0mm sizes. All locking screws can be placed onaxis with the internal plate threads or up to 15 degrees off axis in any direction.
All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional screw washers 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 instruments are not specific to the system.
The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Intended Use:
The intended use of the Tyber Medical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. lt is composed of the Mini-Frag System and Ankle Fracture/ Fusion System with the following indications:
Indications for Use:
Mini-fraq System
The Tyber Medical Mini-Fraq System is indicated for fixation of fractures, nonunions, malunions, replantations, and fusions 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 Mini-frag System is not for Spinal Use.
Ankle Fracture/Fusion System
Tyber Medical Ankle Fracture/Fusion System is indicated for Use in:
-Fixation of fractures of the distal tibia included, but not limited 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 nonunions of the metaphyseal reqion of the distal fibula, and calcaneus;
•In distal tibia/fibula long bones which include the metaphyseal reqions of the tibia and fibula in the ankle. The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.
5
Indications for Use Comparison
The subject indications for use are within those of the primary predicate and identical to the additional predicate indications.
Technological Comparison
The subject plates and screws are identical to those cleared in the additional predicate system. The se in the primary predicate indications (aid in load distribution at the screw head/bone interface), design, dimensions, material, and operating principle.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
All design contol activities, including verification, and other testing, demonstrates that adding optional screw Washers to the Tyber Medical Anatomical Plating System does not raise any questions of safety or performance and is substantially equivalent to the predicate device(s).
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)