Trident Extremity Fixation System

K171690 · Trident Orthopedics · HRS · May 8, 2018 · Orthopedic

Device Facts

• Record ID: K171690
• Device Name: Trident Extremity Fixation System
• Applicant: Trident Orthopedics
• Product Code: HRS · Orthopedic
• Decision Date: May 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Trident Extremity Fixation System comprises titanium plates and screws (locking, non-locking, solid cortical, cannulated, headless) for orthopedic bone fixation; used by surgeons in clinical settings for fracture stabilization, osteotomy, and arthrodesis; system includes reusable instrumentation for implant delivery; provides mechanical stability to bone segments to facilitate healing and reconstruction; device size range (3.0-7.3mm diameter; 10-100mm length) allows selection based on anatomical site and patient needs.

Clinical Evidence

Bench testing only. Testing included static 4-point bending (ASTM F382-14) for plates; axial pullout, axial pushout, torque to failure (ASTM F543), and static/dynamic 3-point bending (ASTM F1264) for screws.

Technological Characteristics

Materials: Titanium (ASTM F-136). Components: Plates, locking/non-locking solid cortical screws, cannulated screws, headless screws. Dimensions: 3.0-7.3mm diameter, 10-100mm length. Mechanical testing standards: ASTM F382-14, ASTM F543, ASTM F1264. Reusable instrumentation included.

Indications for Use

Indicated for stabilization of fresh fractures, revision procedures, joint fusion, and bone reconstruction in feet, hands, ankles, and toes. Includes specific procedures: Lapidus fusion, MTP fusion, hallux valgus/rigidus correction, Weil osteotomy, 5th metatarsal fractures, carpal fusions, flatfoot osteotomies (Evans, Cotton, calcaneal), and midfoot/hindfoot arthrodesis (Lisfranc, TMT, NC, TN, CC joints).

Regulatory Classification

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.

Predicate Devices

• Medline Foot Plates and Screws (K151235)
• Vilex Cannulated Bone Screw/DuVal Cannulated Bone Screw (K991151, K991197)
• Osteomed Cannulated Screw System (K151021)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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## 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.

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## 510(k) Summary (as required by 21 CFR 807.92)

| Date Prepared | May 8, 2018 |
|----------------|------------------------------------------------|
| Manufacturer | Trident Orthopedics |
| Address | 212 Copperwood Court<br>Millersville, MD 21108 |
| Contact Person | Al Austin |
| Address | 212 Copperwood Court<br>Millersville, MD 21108 |
| Telephone | 410-903-9038 |
| Fax | 410-544-3547 |
| email | [e-mail] |

| Trade Name | Trident Extremity Fixation System |
|---------------------|--------------------------------------------------------------------------------|
| Common Name | Bone Screw |
| Panel Code | Orthopaedics/87 |
| Classification Name | Single/multiple component metallic bone fixation appliances and<br>accessories |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | HRS: Plate, Fixation, Bone<br>HWC: Screw, Fixation, Bone |

| Predicate Devices | 510(k) # | Manufacturer |
|------------------------------------------------------------------------------------|---------------------|-----------------|
| Primary Predicate:<br>Medline Foot Plates and Screws | K151235 | Medline |
| Secondary Predicate:<br>Vilex Cannulated Bone Screw/DuVal<br>Cannulated Bone Screw | K991151,<br>K991197 | Vilex, Inc. |
| Secondary Predicate:<br>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<br>Intended Use | The Trident Extremity Fixation System consisting of plates and screws are<br>intended for use in stabilization and fixation of fresh fractures, revision<br>procedures, joint fusion and reconstruction of bone of the feet, hand, ankle<br>and toes. Specific examples include: |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion<br>procedure)<br>- Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure) |
| | - Primary and revision MTP fusion due to hallux rigidus and/or hallux<br>valgus corrections |

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## 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<br>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<br>use with the Trident Plates and Screws of the same material. The locking<br>and non-locking solid cortical screws, cannulated screws and headless<br>screws are also indicated for bone reconstruction, osteotomy, arthrodesis,<br>joint fusion, fracture repair and fracture fixation, appropriate for the size of<br>the device. |

| Technological<br>Characteristics<br>and Substantial<br>Equivalence | Documentation and performance testing was provided to demonstrate that<br>the Subject device is substantially equivalent to the Predicate Medline<br>Foot Plates and Screws (K151235) and the Predicate Vilex Cannulated<br>Bone Screw/DuVal Cannulated Bone Screw (K991151, K991197). The<br>Subject device is substantially equivalent to the predicate devices in<br>intended use, indications for use, materials, technological characteristics,<br>and labeling. |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Performance Data | Bench testing confirmed that the Subject device performed as intended<br>and is at least equivalent to the predicate devices. Static 4-Point bending<br>(ASTM F382-14) was conducted on the plates. Axial Pullout, Axial<br>Pushout, Torque to Failure (ASTM F543) Static Three-Point Bend, and<br>Dynamic Three-Point Bend (ASTM F1264) were performed on the screws. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on the intended use indication for cemented or hybrid<br>fixation, the subject device is substantially equivalent to the predicate<br>devices. |

| Conclusion | Based on the intended use, indications for use, technological<br>characteristics, materials, and comparison to predicate devices, the<br>Subject device has been shown to be substantially equivalent to legally<br>marketed predicate devices. |
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