TREND II Spinal Fixation System- STEP Series

K180226 · Paonan Biotech Co., Ltd. · NKB · Jul 25, 2018 · Orthopedic

Device Facts

• Record ID: K180226
• Device Name: TREND II Spinal Fixation System- STEP Series
• Applicant: Paonan Biotech Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Jul 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/liac spine (T1-Sacrum/Ilium) for the following indications: - Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - Degenerative Spondylolisthesis with objective evidence of neurologic impairment - Fractures - Dislocation - Scoliosis - Kyphosis - Spinal tumor - Failed previous fusion (pseudarthrosis)

Device Story

TREND II Spinal Fixation System- STEP Series consists of orthopedic implants including cannulated/non-cannulated screws, rods, set screws, hooks, and transverse links; used for posterior, non-cervical pedicle fixation of thoracic, lumbar, and sacral/iliac spine. System provides immobilization and stabilization of spinal segments as an adjunct to fusion using autograft. Implants are selected based on patient pathology. Used in clinical settings by surgeons; device provides mechanical support to spine to facilitate fusion and treat conditions like scoliosis, fractures, or degenerative disc disease. Benefits include spinal stabilization and correction of deformities.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing including static and dynamic axial compression bending tests, static torsion tests (ASTM F1717), and pullout tests (ASTM F543).

Technological Characteristics

Materials: Ti6Al4V (ASTM F136/ISO 5832-3). Components: cannulated/non-cannulated screws, rods, set screws, hooks, transverse links. Non-sterile. Mechanical testing per ASTM F1717 and ASTM F543.

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1-Sacrum/Ilium) for degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fractures, dislocation, scoliosis, kyphosis, spinal tumor, or pseudarthrosis.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Paonan Armstrong Posterior Spinal Fixation System (K161225)
• MYKRES Spinal System (K051704)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 the FDA logo, which 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.

July 25, 2018

Paonan Biotech Co., Ltd. Ms. Vivi Tsai Regulatory Affairs 3F. No. 50. Lane 258. Rueiguang Road Neihu District, Taipei City 114 TAIWAN

Re: K180226

Trade/Device Name: TREND II Spinal Fixation System- STEP Series Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: July 13, 2018 Received: July 13, 2018

Dear Ms. Tsai:

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, 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 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 (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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.

# Ronald P. Jean -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

510(k) Number (if known) K180226

Device Name

TREND II Spinal Fixation System - STEP Series

#### Indications for Use (Describe)

TREND II Spinal Fixation System - STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/liac spine (T1-Sacrum/Ilium) for the following indications:

- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)

- Degenerative Spondylolisthesis with objective evidence of neurologic impairment
- Fractures
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Failed previous fusion (pseudarthrosis)

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <input checked="true" type="checkbox"/> Research Use (Part 21 CFR 201.3 Subject to Discretion) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 201.3 Subject to Discretion) |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|

> 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

# ADMINISTRATIVE INFORMATION

| Manufacturer Name | Paonan Biotech Co.,Ltd. |
|------------------------------|-----------------------------------------------------------------------------------|
| Manufacturer Address | 3F, No.50, Lane.258, Rueiguang Rd.,<br>Neihu District, Taipei City, Taiwan,R.O.C. |
| DEVICE NAME | TREND II Spinal Fixation System- STEP Series |
| Contact Person/Date Prepared | Vivi Tsai/July 20, 2018 |

# Common / Classification Name

Thoracolumbosacral Pedicle Screw System, 21 CFR 888.3070, Class II

Product code: NKB

## Predicate Device

Primary predicate device: "Paonan" Armstrong Posterior Spinal Fixation System (K161225)

| | Subjective Device | Primary Predicate<br>Device | Additional predicates |
|----------------------------|-------------------------------------------------|--------------------------------------------------------|-------------------------------|
| System name | TREND II Spinal Fixation System-<br>STEP Series | "Paonan" Armstrong Posterior<br>Spinal Fixation System | MYKRES Spinal System |
| 510(k) Number | -- | K161225 | K051704 |
| Manufacturer | PAONAN | PAONAN | Showa Ika |
| Materials | Ti6Al4V | Ti6Al4V | Ti6Al4V |
| Classification | 888.3070 | 888.3070 | 888.3070 |
| Product Code | NKB | NKB | MNI |
| Subsequent<br>Product Code | N/A | N/A | KWP, MNH |
| Required<br>Standard | Ti6Al4V-ISO 5832-3, ASTMF 136 | Ti6Al4V-ISO 5832-3, ASTMF 136 | Ti6Al4V-ISO 5832-3, ASTMF 136 |
| Application | thoracic, lumbar to sacrum | thoracic, lumbar to sacrum | thoracic, lumbar to sacrum |
| Intend Use | To provide | To provide | To provide |

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| | immobilization and<br>stabilization for<br>posterior, non-<br>cervical, pedicle<br>fixation of the<br>thoracic, lumbar, and<br>sacral/iliac spine (T1 –<br>Sacrum/Ileum) in<br>skeletally mature<br>patients. | immobilization and<br>stabilization for<br>posterior, non-<br>cervical, pedicle<br>fixation of the<br>thoracic, lumbar, and<br>sacral/iliac spine (T1 –<br>Sacrum/Ileum) in<br>skeletally mature<br>patients. | immobilization and<br>stabilization for<br>posterior, non-<br>cervical, pedicle and<br>non-pedicle fixation<br>of the thoracic,<br>lumbar, and sacral<br>spine in skeletally<br>mature patients. |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication | Degenerative disc diseases Degenerative Spondylolisthesis Fractures Dislocation Scoliosis kyphosis Spinal tumor Failed previous fusion<br>(pseudarthrosis) | Degenerative disc diseases Degenerative Spondylolisthesis Fractures Dislocation Scoliosis kyphosis Spinal tumor Failed previous fusion<br>(pseudarthrosis) | Degenerative Spondylolisthesis Fractures Dislocation Scoliosis kyphosis Spinal tumor Failed previous fusion<br>(pseudarthrosis) |
| Component | Cannulated screw, non-<br>cannulated screw, rod, set screw,<br>hook, transverse link | Cannulated screw,<br>mono-axial screw,<br>poly-axial screw,<br>block, washer, rod,<br>link, connector, set<br>screw | rods, mono-axial<br>screw, poly-axial<br>screw, hooks and<br>connectors |
| Sterilization | Non-sterile | Non-sterile | Non-sterile |
| Mechanical Test | Static and dynamic<br>compression test,<br>Static Torsional Test per<br>ASTM F1717, and Pullout Test per<br>ASTM F543 | Static and dynamic<br>compression<br>bending Test, Static<br>Torsional Test per<br>ASTM F1717<br>Axial gripping<br>capacity test and<br>Axial torque<br>gripping capacity<br>test per ASTM<br>F1798 | Static compression,<br>static torsion, and<br>dynamic<br>compression per<br>ASTM F1717 |

### Device Description

TREND II Spinal Fixation System- STEP Series includes cannulated screw, non-cannulated screw, rod, set screw, hook, and transverse link. Different types or sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology

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of individual patients. The system components are manufactured from Ti6Al4V based which complies with ASTM F136 /ISO 5832-3.

#### Indications for Use

TREND II Spinal Fixation System- STEP Series is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion using autograft. This system is intended for posterior, non-cervical pedicle fixation of the thoracic, lumbar, and sacral/iliac spine (T1 – Sacrum/Ilium) for the following indications:

- Degenerative disc diseases (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Degenerative Spondylolisthesis with objective evidence of neurologic impairment.
- Fractures
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Failed previous fusion (pseudarthrosis)

#### Performance Data:

Mechanical testing including static/dynamic axial compression bending test and static torsion test for spinal corpectomy model were conducted referring to ASTM F1717 to demonstrate substantial equivalence to the predicate system. In addition, pullout test of multiaxial screw was performed according to ASTM F543. The results demonstrate substantial equivalence of TREND II Spinal Fixation System- STEP Series to the predicate device(s).

## Conclusion of Substantial Equivalence:

The TREND II Spinal Fixation System- STEP Series has been demonstrated to be substantially equivalent to the predicate(s) with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device(s).