Premier

K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · MNI · Apr 1, 2016 · Orthopedic

Device Facts

• Record ID: K160320
• Device Name: Premier
• Applicant: Shandong Weigao Orthopaedic Device Co., Ltd.
• Product Code: MNI · Orthopedic
• Decision Date: Apr 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft.

Device Story

Premier is a pedicle screw spinal system consisting of various titanium alloy components: fixed-angle screws, multi-axial screws, reduction screws, rods, crosslink plates, set screws, connectors, and hooks. Used in orthopedic surgery to provide posterior, non-cervical, pedicle fixation. Surgeons implant these components to stabilize and immobilize the spine during fusion procedures. The device acts as an internal fixation construct to support the spine while bone graft facilitates fusion. It is provided non-sterile and requires hospital-based steam sterilization before use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Titanium Alloy (Ti6Al4V) per ASTM F136-13. Components: Fixed-angle/multi-axial screws, rods, crosslink plates, connectors, hooks. Sterilization: Steam autoclave (SAL 10^-6) per ISO 17665-1:2006. Mechanical testing: ASTM F1717-13 (static/dynamic compression bending, static torsion).

Indications for Use

Indicated for skeletally mature patients requiring posterior, non-cervical, pedicle fixation for severe spondylolisthesis (grade 3 or 4) at L5-S1, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion, as an adjunct to spinal fusion with bone graft.

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

• XIA®3 Spinal System (K113666)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, 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 Company, Ltd % Ms. Diana Hong General Manager Mid-link Consulting Company, Ltd P.O. Box 120-119 Shanghai 200120 CHINA

Re: K160320

Trade/Device Name: Premier Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: February 1, 2016 Received: February 5, 2016

Dear Ms. Hong:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

April 1, 2016

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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" (21CFR 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 yours,

# 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)

K160320

Device Name Premier

#### Indications for Use (Describe)

The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications:severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K160320

- 1. Date of Preparation: 03/24/2016
- 2. Sponsor Identification

### Shandong Weigao Orthopaedic Device Co., Ltd. No. 26 Xiangjiang Road, Tourist Resorts Weihai Shandong 264203 China

Establishment Registration Number: 3006639944

Contact Person: Han Wang Position: R&D Vice Director Tel: [phone] Fax: [phone] Email: [e-mail]

- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Premier Common Name: General Spinal System

#### Regulatory Information

Primary Classification Name: Pedicle screw spinal system Primary Regulation Number: 21CFR 888.3070 Classification: II Product Codes: MNI, MNH Review Panel: Orthopedic

Subsequent Classification Name: Spinal interlaminal fixation orthosis Subsequent Regulation Number: 21CFR 888.3050 Classification: II Product Code: KWP Review Panel: Orthopedic

Intended Use Statement:

The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft.

#### Device Description

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, 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) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° 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:

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Requirements for the development, validation, and routine control of a sterilization process for medical devices.

- Identification of Primary Predicate Device న్.
510(k) Number: K113666 Product Name: XIA®3 Spinal System

- 6. Non-Clinical Test Conclusion
Non clinical tests and engineering rationales were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F 1717-13, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items

- A Static compression bending test
- > Dynamic compression bending test
- A Static torsion test
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- 8. Substantially Equivalent (SE) Comparison

| Item | Proposed Device | Predicate Device |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | MNI, MNH, KWP | OSH, MNH, MNI, KWP, NKB |
| Regulation<br>Number | 21 CFR part 888.3070, 21 CFR part<br>888.3050 | 21 CFR part 888.3070, 21 CFR part<br>888.3050 |
| Intended Use | The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: | The XIA®3 Spinal System is intended for use in the noncervical spine. When used an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA®3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally |
| | | mature patient in the treatment of the |
| | | following acute and chronic instabilities<br>or deformities |
| | | |
| | Severe spondylolisthesis (grade 3 or<br>4) of the L5-S1 vertebrae | Spondylolisthesis |
| | Trauma (i.e. fracture or dislocation) | Trauma |
| | Spinal stenosis | Spinal stenosis |
| | Curvatures (i.e. scoliosis, kyphosis,<br>and/or lordosis); | Curvatures (i.e. Scoliosis,<br>kyphosis,and/or lordosis) |
| | Tumor | Tumor |
| | Pseudoarthrosis; | Pseudoarthrosis |
| | Failed previous fusion. | Failed previous fusion |
| | The device is to be used in skeletally<br>mature patients, and for stabilization<br>and immobilization of the spine as an<br>adjunct to fusion with bone graft. | Degenerative disc disease (DDD)<br>(defined as back pain of discogenic<br>origin with degeneration of the disc<br>confirmed by history and radiographic<br>studies) |
| | Rod | Rod |
| | Multi Axial Screw | Multi Axial Screw |
| | Multi-Axial Reduction Screw | NA |
| Configuration | Fixed Angle Screw | Fixed Angle Screw |
| | Fixed Angle Reduction Screw | NA |
| | Planar Screw | Planar Screw |
| | Iliac Screw | Iliac Screw |
| | Crosslink Plate | Crosslink Plate |
| | Set Screw | Blocker |
| | Domino Connector | Domino Connector |
| | Lateral Connector | Lateral Connector |
| | Hook | Hook |
| Sterile | Steam | Steam |
| | 10^-6 | 10^-6 |

Table 1 Comparison of Technology Characteristics

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#### 9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.