(335 days)
Not Found
No
The device description and intended use focus on the physical components (plates, screws, instrumentation) and their mechanical function in bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The Trident Extremity Fixation System is explicitly intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bone, which are all therapeutic interventions aimed at treating medical conditions.
No
Explanation: The device, the Trident Extremity Fixation System, consists of plates and screws intended for the stabilization and reconstruction of bone in the feet, hand, ankle, and toes. Its purpose is to physically fix and support bone structures, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is manufactured from titanium and includes plates, screws, and reusable instrumentation, which are all hardware components.
Based on the provided information, the Trident Extremity Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the stabilization of bone fractures, fusions, and reconstructions within the body (feet, hand, ankle, toes). This is a surgical implant used for structural support.
- Device Description: The description details plates and screws made of titanium, which are implantable components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The Trident Extremity Fixation System is an implantable medical device used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include:
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure)
- Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure)
- Primary and revision MTP fusion due to hallux rigidus and/or hallux valgus corrections
- Revision of failed first MTP arthroplasty implant 2nd, 3rd and 4th metatarsal weil osteotomy correction indications
- Metatarsal osteotomies to correct hallux valgus bunion indications
- Fractures of the fifth metatarsal bone in the foot
- Carpal bone fusions and fractures
Flatfoot Osteotomies:
- Lateral column lengthening (Evans osteotomy)
- Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton osteotomy)
- Medial displacement calcaneal osteotomy
- Midfoot/Hindfoot Arthrodesis/Fusions
- Lisfranc arthrodesis and/or stabilization
- 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions
- Navicular-Cuneiform (NC) joint fusions
- Talo-Navicular (TN) joint fusions
- Calcaneo-Cuboid (CC) joint fusions
- Medial column fusions (NC and 1st TMT)
The Trident Extremity Fixation System screws and plates are indicated for use with the Trident Plates and Screws of the same material. The locking and non-locking solid cortical screws, cannulated screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device.
Product codes
HRS, HWC
Device Description
The Subject device is manufactured from titanium conforming to ASTM F-136. The system includes plates in various sizes as well as locking and non-locking screws to be used with the plates. The bones screws are available in diameter sizes from 3.0 mm to 7.3 mm diameter and lengths from 10 mm to 100 mm. The system also includes reusable instrumentation for delivery of the implantable components. The Subject device has a similar range of sizes as its predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet, hand, ankle and toes. Specific examples include: first metatarsalcuneiform joint, first metatarsalphalangeal joint, fifth metatarsal bone, carpal bone, Midfoot/Hindfoot.
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)
Bench testing confirmed that the Subject device performed as intended and is at least equivalent to the predicate devices. Static 4-Point bending (ASTM F382-14) was conducted on the plates. Axial Pullout, Axial Pushout, Torque to Failure (ASTM F543) Static Three-Point Bend, and Dynamic Three-Point Bend (ASTM F1264) were performed on the screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151235, K991151, K991197, K151021
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2018
Trident Orthopedics % Al Memmolo Official Correspondent 6648 Surf Crest Street Carlsbad, California 92011
Re: K171690
Trade/Device Name: Trident Extremity Fixation 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: March 28, 2018 Received: March 30, 2018
Dear Al Memmolo:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K171690
Device Name
The Trident Extremity Fixation System
Indications for Use (Describe)
The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include:
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure)
- Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure)
- Primary and revision MTP fusion due to hallux rigidus and/or hallux valgus corrections
- Revision of failed first MTP arthroplasty implant 2nd, 3rd and 4th metatarsal weil osteotomy correction indications
- Metatarsal osteotomies to correct hallux valgus bunion indications
- Fractures of the fifth metatarsal bone in the foot
- Carpal bone fusions and fractures
Flatfoot Osteotomies:
- Lateral column lengthening (Evans osteotomy)
- Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton osteotomy)
- Medial displacement calcaneal osteotomy
- Midfoot/Hindfoot Arthrodesis/Fusions
- Lisfranc arthrodesis and/or stabilization
- 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions
- Navicular-Cuneiform (NC) joint fusions
- Talo-Navicular (TN) joint fusions
- Calcaneo-Cuboid (CC) joint fusions
- Medial column fusions (NC and 1st TMT)
The Trident Extremity Fixation System screws and plates are indicated for use with the Trident Plates and Screws of the same material. The locking and non-locking solid cortical screws, cannulated screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device.
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.
3
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
510(k) Summary (as required by 21 CFR 807.92)
| Date Prepared | May 8, 2018 |
|---|---|
| Manufacturer | Trident Orthopedics |
| Address | 212 Copperwood Court |
| Millersville, MD 21108 | |
| Contact Person | Al Austin |
| Address | 212 Copperwood Court |
| Millersville, MD 21108 | |
| Telephone | 410-903-9038 |
| Fax | 410-544-3547 |
| telosusa@aol.com |
| Trade Name | Trident Extremity Fixation System |
|---|---|
| Common Name | Bone Screw |
| Panel Code | Orthopaedics/87 |
| Classification Name | Single/multiple component metallic bone fixation appliances and |
| accessories | |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | HRS: Plate, Fixation, Bone |
| HWC: Screw, Fixation, Bone |
| Predicate Devices | 510(k) # | Manufacturer |
|---|---|---|
| Primary Predicate: | ||
| Medline Foot Plates and Screws | K151235 | Medline |
| Secondary Predicate: | ||
| Vilex Cannulated Bone Screw/DuVal | ||
| Cannulated Bone Screw | K991151, | |
| K991197 | Vilex, Inc. | |
| Secondary Predicate: | ||
| Osteomed Cannulated Screw System | K151021 | Osteomed, Corp. |
| Description | The Subject device is manufactured from titanium conforming to ASTM F-136. The system includes plates in various sizes as well as locking and non-locking screws to be used with the plates. The bones screws are available in diameter sizes from 3.0 mm to 7.3 mm diameter and lengths from 10 mm to 100 mm. The system also includes reusable instrumentation for delivery of the implantable components. The Subject device has a similar range of sizes as its predicate. |
|---|---|
| ------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Indications and
Intended Use | The Trident Extremity Fixation System consisting of plates and screws are
intended for use in stabilization and fixation of fresh fractures, revision
procedures, joint fusion and reconstruction of bone of the feet, hand, ankle
and toes. Specific examples include: |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion
procedure)
- Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure) |
| | - Primary and revision MTP fusion due to hallux rigidus and/or hallux
valgus corrections |
5
K171690
| - Revision of failed first MTP arthroplasty implant |
|---|
| 2nd, 3rd and 4th metatarsal weil osteotomy correction indications |
| Metatarsal osteotomies to correct hallux valgus bunion indications |
| Fractures of the fifth metatarsal bone in the foot |
| Carpal bone fusions and fractures |
| Flatfoot Osteotomies: |
| - Lateral column lengthening (Evans osteotomy) |
| - Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton |
| osteotomy) |
| - Medial displacement calcaneal osteotomy |
| Midfoot/Hindfoot Arthrodesis/Fusions |
| - Lisfranc arthrodesis and/or stabilization |
| - 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions |
| - Navicular-Cuneiform (NC) joint fusions |
| - Talo-Navicular (TN) joint fusions |
| - Calcaneo-Cuboid (CC) joint fusions |
| - Medial column fusions (NC and 1st TMT) |
| The Trident Extremity Fixation System screws and plates are indicated for |
| use with the Trident Plates and Screws of the same material. The locking |
| and non-locking solid cortical screws, cannulated screws and headless |
| screws are also indicated for bone reconstruction, osteotomy, arthrodesis, |
| joint fusion, fracture repair and fracture fixation, appropriate for the size of |
| the device. |
| Technological
Characteristics
and Substantial
Equivalence | Documentation and performance testing was provided to demonstrate that
the Subject device is substantially equivalent to the Predicate Medline
Foot Plates and Screws (K151235) and the Predicate Vilex Cannulated
Bone Screw/DuVal Cannulated Bone Screw (K991151, K991197). The
Subject device is substantially equivalent to the predicate devices in
intended use, indications for use, materials, technological characteristics,
and labeling. |
| -------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Performance Data | Bench testing confirmed that the Subject device performed as intended
and is at least equivalent to the predicate devices. Static 4-Point bending
(ASTM F382-14) was conducted on the plates. Axial Pullout, Axial
Pushout, Torque to Failure (ASTM F543) Static Three-Point Bend, and
Dynamic Three-Point Bend (ASTM F1264) were performed on the screws. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on the intended use indication for cemented or hybrid
fixation, the subject device is substantially equivalent to the predicate
devices. |
| Conclusion | Based on the intended use, indications for use, technological
characteristics, materials, and comparison to predicate devices, the
Subject device has been shown to be substantially equivalent to legally
marketed predicate devices. |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|