Premier

K170861 · Shandong Weigao Orthopaedic Device Co., Ltd. · NKB · Aug 4, 2017 · Orthopedic

Device Facts

• Record ID: K170861
• Device Name: Premier
• Applicant: Shandong Weigao Orthopaedic Device Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Aug 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

Device Story

Premier Spinal System is a pedicle screw system for spinal stabilization; consists of fixed-angle screws, multi-axial screws, reduction screws, rods, crosslink plates, set screws, iliac screws, connectors, and hooks. Used by surgeons in clinical settings to immobilize spinal segments as an adjunct to fusion. Implants are made of titanium alloy; provided non-sterile and require hospital-based autoclave sterilization. Device provides mechanical support to the spine to facilitate fusion and treat instabilities/deformities.

Clinical Evidence

Bench testing only; no clinical data provided. Performance determined via engineering rationales comparing subject device to predicate systems.

Technological Characteristics

Materials: Titanium Alloy (Ti6Al4V) per ASTM F136-13. Components: fixed/multi-axial screws, rods, crosslinks, connectors, hooks. Sterilization: Moist heat (autoclave) per ISO 17665-1:2006 to SAL 10^-6. Non-sterile delivery.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral (T1-S1) instabilities or deformities, including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, scoliosis, kyphosis, lordosis, tumor, and pseudoarthrosis.

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

• Weigao Orthopaedic Premier (K160320)
• EXPEDIUM® Spine System (K101070)
• Vitality® Spinal Fixation System (K150896)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shandong Weigao Orthopaedic Device Co., Ltd. % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

August 4, 2017

Re: K170861

Trade/Device Name: Premier Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: July 5, 2017 Received: July 6, 2017

Dear Mr. Eggleton:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Mark N. Melkerson -S

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) K170861

Device Name Premier

#### Indications for Use (Describe)

The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

| Device Trade Name: | Premier |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Shandong Weigao Orthopaedic Device Co., Ltd.<br>No. 26 Xiangjiang Road, Tourist Resorts<br>Weihai, Shandong China 264203<br>[phone] |
| Contact: | Han Wang<br>R&D Vice Director<br>Shandong Weigao Orthopaedic Device Co., Ltd.<br>No. 26 Xiangjiang Road, Tourist Resorts<br>Weihai, Shandong China 264203 |
| Prepared by: | Mr. Justin Eggleton<br>Senior Director, Spine Regulatory Affairs<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | July 5, 2017 |
| Classification: | 21 CFR §888.3070, Thoracolumbosacral pedicle screw system |
| Class: | II |
| Product Codes: | NKB, KWP |
| Predicate Device: | Weigao Orthopaedic Premier (K160320) |
| Additional Predicate<br>Devices: | EXPEDIUM® Spine System (K101070)<br>Vitality® Spinal Fixation System (K150896) |

## Indications for Use:

The Premier is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

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## Device Description:

The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks.

It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

## Predicate Device:

The subject Premier is substantially equivalent to the primary predicate device Premier (K160320) and additional predicate devices EXPEDIUM® Spine System (K101070) and Vitality@ Spinal Fixation System (K150896) with respect to indications, design, materials, function, and performance.

#### Performance Testing:

The performance of the subject Premier System was determined based on a series of engineering rationales compared to the predicate devices cited in the previous section

#### Substantial Equivalence:

The subject Premier System is substantially equivalent to the primary predicate device Premier (K160320) and additional predicate devices EXPEDIUM® Spine System (K101070) and Vitality® Spinal Fixation System (K150896) with respect to indications, design, materials, function, and performance.