(59 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for the Tyber Medical Anatomical Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials as would be the case for a novel drug or high-risk medical device.
Therefore, the document does not contain acceptance criteria related to device performance in a clinical study, nor does it describe a study proving the device meets such criteria.
Instead, the submission asserts that the Tyber Medical Anatomical Plating System is "substantially equivalent" to a predicate device, the BioPro Foot Plating Systems (K162674). This substantial equivalence is based on similarities in design, material, technological characteristics, and indications for use.
Here's a breakdown of why the requested information cannot be fully provided from this document:
-
Acceptance Criteria & Reported Device Performance: This document does not describe specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for the device that would be typically established in a study. The acceptance criteria for a 510(k) submission revolve around demonstrating equivalence to a predicate, not absolute clinical performance.
-
Study That Proves Device Meets Acceptance Criteria: No clinical study is described that tests the Tyber Medical Anatomical Plating System against specific performance criteria. The submission explicitly states: "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". This indicates that no new nonclinical or clinical testing was performed for this specific 510(k) submission to demonstrate performance.
Given this context, I cannot fill out the detailed table and answer the questions pertaining to clinical study design, sample sizes, expert involvement, and ground truth establishment, as the information is not present in the provided text.
The closest information related to "acceptance criteria" is that the device is considered substantially equivalent if it has the "same in design, material, technological characteristics and indications" as the predicate device. The "study" for this type of submission is primarily the comparison analysis and documentation provided to the FDA to support the claim of substantial equivalence.
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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
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 Nameand Number | Single/multiple component metallic bone fixation appliances andaccessories (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 followingcategories: |
| 1. Forefoot System | |
| 2. Mid & Hindfoot System | |
| 3. Ankle Fracture System |
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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
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| Tyber Medical Mid and Hindfoot System is offered both sterile andnon- sterile for single-use. |
|---|
| Ankle Fracture System |
| The Tyber Medical Ankle Fracture System is designed to address avariety of indications in ankle reconstruction mid-shaft and distaltibia/fibula fixation surgery. The system is composed of many lockingplate types which include:1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateralDistal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight LowContact Plates, and 6). Straight 1/3 Tubular Plates – in various plateshapes, lengths, Right & Left versions. The System will incorporate bothCortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm,3.5mm and 4.0mm sizes in various lengths. All plates are composed ofeither 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 Titaniummaterial (to ASTM F136) color anodized for sizing. |
| A full set of Ancillary Instrumentation is available with the system. TheTyber 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 Systemis to draw two or more aligned bone fragments together tofacilitate healing in an adult patient |
|---|---|
| Indications for Use | I. Forefoot System:The Tyber Medical Forefoot Plating System is Indicated for Use infixation of small bones and small bone fragments in the foot(Phalanges and Metatarsals) for stabilization of fractures, jointfusions, osteotomies, nonunions, malunions, reconstruction ofsmall bones, revision surgeries and replantations in an adultpatient.The Tyber Medical Forefoot Plating System is not for Spinal Use.II. Mid & Hindfoot System:The Tyber Medical Mid & Hindfoot Plating System is Indicated forUse in fixation of medium/large bones and medium/large bonemulti-fragments in the foot (Cuneiform, Cuboid, Navicular, Talusand Calcaneus) for stabilization of fractures, joint fusions,osteotomies, nonunions, malunions, reconstruction of |
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| 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 notlimited to, ankle fractures, perarticular fractures, corrective | medium/large bones, revision surgeries and replantations in anadult patient.The Tyber Medical Mid & Hindfoot Plating System is not for SpinalUse. |
|---|---|
| osteotomies, non-unions, intra- and extra- articular anddistal tibia fractures with a shaft extension, and malleolarfractures;2). In intra- and extra articular fractures, osteotomies, medialmalleolar fractures and non-unions of the metaphyseal anddiaphyseal region of the distal fibula;3). In distal tibia/fibula long bones which include themetaphyseal and diaphyseal regions of the tibia and fibulain 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 TestingSummary | There have been no changes to the design, material,technological characteristics or indications of the platingsystems 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). |
|---|---|
| ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.