(59 days)
Not Found
No
The device description focuses on the materials, shapes, and sizes of bone plates and screws, and mentions ancillary instrumentation. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes
The device is described with an "Intended Use" that explicitly states it is used "to draw two or more aligned bone fragments together to facilitate healing in an adult patient," and lists indications for stabilization of fractures, joint fusions, osteotomies, and reconstruction of bones, all of which are therapeutic interventions.
No
The Tyber Medical Anatomical Plating System is used for surgical fixation of bone fragments to facilitate healing, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of titanium (plates and screws) and ancillary instrumentation, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The Tyber Medical Anatomical Plating System is described as a system of plates and screws made of titanium materials. Its intended use is to physically fix and stabilize bone fragments within the body to facilitate healing. This is an in vivo (within the body) application.
The device is a surgical implant used to treat bone fractures and other orthopedic conditions. It does not involve the analysis of biological specimens outside the body.
N/A
Intended Use / Indications for Use
The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories:
I. Forefoot System:
The Tyber Medical Forefoot Plating System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Tyber Medical Forefoot System is not for Spinal Use.
II. Mid & Hindfoot System:
The Tyber Medical Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/ large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.
The Tyber Medical Mid & Hindfoot System is not for Spinal Use.
III. Ankle Fracture System:
The Tyber Medical Ankle Fracture System is Indicated for Use in:
I). 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;
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 System is not for Spinal Use.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Tyber Medical Anatomical Plating System consists of the following categories:
- Forefoot System
- Mid & Hindfoot System
- Ankle Fracture System
A brief and concise description of each system is as follows:
Forefoot System
The Tyber Medical Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Forefoot System is offered both sterile and non-sterile for single-use.
Mid and Hindfoot System
The Tyber Medical Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include:
1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions.
The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Mid and Hindfoot System is offered both sterile and non- sterile for single-use.
Ankle Fracture System
The Tyber Medical Ankle Fracture 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 many locking plate types which include:
1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates – in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture System is offered both sterile and non- sterile for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot (Phalanges, Metatarsals, Cuneiform, Cuboid, Navicular, Talus, Calcaneus), Ankle (distal tibia, distal fibula)
Indicated Patient Age Range
Adult patient
Intended User / Care Setting
Prescription Use
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)
Nonclinical Testing Summary: There have been no changes to the design, material, technological characteristics or indications of the plating systems since receiving clearance in K162674. Therefore, nonclinical testing is not provided in this submission.
Clinical Test Summary: n/a
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.
BioPro Foot Plating Systems – K162674
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
January 20, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Tyber Medical LLC Jessica Stigliano Regulatory Affairs Specialist 83 South Commerce Way, Suite 310 Bethlehem, Pennsylvania 18017
Re: K193222
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: November 22, 2019 Received: November 22, 2019
Dear Jessica Stigliano:
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.
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
1
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 (OS) 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 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,
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) K193222
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 in an adult patient and is composed of the following bone plate categories:
I. Forefoot System:
The Tyber Medical Forefoot Plating System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Tyber Medical Forefoot System is not for Spinal Use.
II. Mid & Hindfoot System:
The Tyber Medical Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/ large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.
The Tyber Medical Mid & Hindfoot System is not for Spinal Use.
III. Ankle Fracture System:
The Tyber Medical Ankle Fracture System is Indicated for Use in:
I). 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;
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 System is not for Spinal Use.
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.
3
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4
Traditional 510(k) Summary
as required by section 807.92(c).
Tyber Medical Anatomical Plating System
K193222
| Submitted | 11/20/2019 |
|---|---|
| Submitter: | Tyber Medical LLC |
| 83 South Commerce Way, Suite 310 | |
| Bethlehem, PA 18017 | |
| Contact Person | Primary Contact: |
| Jessica Stigliano | |
| Regulatory Affairs Specialist | |
| Phone: 866-761-0933 (ext. 424) Fax: (866) 889-9914 | |
| Email: jstigliano@tybermed.com | |
| Secondary Contact: | |
| Mark Schenk | |
| V.P. Regulatory | |
| Phone: 610-849-0645 | |
| Email: mschenk@tybermed.com | |
| Trade Name | Tyber Medical Anatomical Plating System |
| Common Name | Plate, Fixation, Bone; Screw, Fixation, Bone |
| Device Class | Class II |
| Classification Name | |
| and Number | Single/multiple component metallic bone fixation appliances and |
| accessories (21 CFR 888.3030) | |
| Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) | |
| Classification Panel: | Orthopedic |
| Product Code | HRS/HWC |
| Predicate Devices | BioPro Foot Plating Systems – K162674 |
| Device Description | The Tyber Medical Anatomical Plating System consists of the following |
| categories: | |
| 1. Forefoot System | |
| 2. Mid & Hindfoot System | |
| 3. Ankle Fracture System |
5
A brief and concise description of each system is as follows:
Forefoot System
The Tyber Medical Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Forefoot System is offered both sterile and non-sterile for single-use.
Mid and Hindfoot System
The Tyber Medical Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include:
1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions.
The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.
A full set of Ancillary Instrumentation is available with the system. The
6
| Tyber Medical Mid and Hindfoot System is offered both sterile and
| non- sterile for single-use. |
|---|
| Ankle Fracture System |
| The Tyber Medical Ankle Fracture 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 many locking |
| plate types which include: |
| 1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral |
| Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low |
| Contact Plates, and 6). Straight 1/3 Tubular Plates – in various plate |
| shapes, lengths, Right & Left versions. The System will incorporate both |
| Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, |
| 3.5mm and 4.0mm sizes in various lengths. All plates are composed of |
| either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium |
| (to ASTM F136) materials with an Anodized Type II surface treatment. |
| All screws are composed of Medical Grade 6-4 Alloyed Titanium |
| material (to ASTM F136) color anodized for sizing. |
| A full set of Ancillary Instrumentation is available with the system. The |
| Tyber Medical Ankle Fracture System is offered both sterile and non- |
| sterile for single-use. |
| Intended Use | The intended use of the Tyber Medical Anatomical Plating System
is to draw two or more aligned bone fragments together to
facilitate healing in an adult patient |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | I. Forefoot System:
The Tyber Medical Forefoot Plating System is Indicated for Use in
fixation of small bones and small bone fragments in the foot
(Phalanges and Metatarsals) for stabilization of fractures, joint
fusions, osteotomies, nonunions, malunions, reconstruction of
small bones, revision surgeries and replantations in an adult
patient.
The Tyber Medical Forefoot Plating System is not for Spinal Use.
II. Mid & Hindfoot System:
The Tyber Medical Mid & Hindfoot Plating System is Indicated for
Use in fixation of medium/large bones and medium/large bone
multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus
and Calcaneus) for stabilization of fractures, joint fusions,
osteotomies, nonunions, malunions, reconstruction of |
7
| Ankle Fracture System:
III.
The Tyber Medical Ankle Fracture System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not
limited to, ankle fractures, perarticular fractures, corrective | medium/large bones, revision surgeries and replantations in an
adult patient.
The Tyber Medical Mid & Hindfoot Plating System is not for Spinal
Use. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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;
3). In distal tibia/fibula long bones which include the
metaphyseal and diaphyseal regions of the tibia and fibula
in the ankle.
The Tyber Medical Ankle Fracture System is not for Spinal Use. | |
| Statement of | The Tyber Medical Anatomical Plating System is the same in |
|---|---|
| Technological | design, material, technological characteristics and |
| Comparison and | indications when compared to the predicate, BioPro Foot |
| Fundamental Scientific | Plating Systems (K162674). |
| Technology |
| Nonclinical Testing
Summary | There have been no changes to the design, material,
technological characteristics or indications of the plating
systems since receiving clearance in K162674. Therefore,
nonclinical testing is not provided in this submission. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |
| Conclusion | The Tyber Medical Anatomical Plating System is the same in design, material, technological characteristics, and indications when compared to the BioPro Foot Plating Systems (K162674). |
|---|---|
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |