IRENE Thoracolumbar Fixation System

K172267 · Tianjin Zhengtian Medical Instrument Co., Ltd. · NKB · Mar 6, 2018 · Orthopedic

Device Facts

• Record ID: K172267
• Device Name: IRENE Thoracolumbar Fixation System
• Applicant: Tianjin Zhengtian Medical Instrument Co., Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Mar 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IRENE Thoracolumbar Fixation System provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Device Story

Thoracolumbar fixation system; provides spinal segment stabilization/immobilization as adjunct to fusion. Components include pedicle screws, reduction screws, titanium rods, and transverse connectors. Used in surgical settings by orthopedic/spinal surgeons. Device bridges spinal segments to provide mechanical support for fusion. Benefits include stabilization of acute/chronic spinal instabilities or deformities. Supplied non-sterile; requires moist heat sterilization by user prior to surgery.

Clinical Evidence

No clinical data presented. Substantial equivalence supported by bench testing (ASTM F1717-15) comparing mechanical properties to predicate.

Technological Characteristics

Materials: Titanium alloy (ASTM F136). Components: Pedicle screws, reduction screws, titanium rods, transverse connectors. Sterilization: Moist heat (ISO 17665-1) to SAL 10^-6. Single-use. No surface coatings. Mechanical testing per ASTM F1717-15.

Indications for Use

Indicated for patients requiring spinal stabilization/immobilization as an adjunct to fusion for trauma (fracture/dislocation), spinal curvatures (scoliosis/lordosis), spinal tumors, failed previous fusion, pseudarthrosis, or spinal stenosis. Contraindicated for pedicle screw fixation above T8.

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

• Devine Spinal System (K111690)

Submission Summary (Full Text)

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## March 6. 2018

Tianjin Zhengtian Medical Instrument Co., Ltd. Changli Ou Regulatory Affairs Specialist No. 318, Jingyi Road, Airport Economic Zone Tianjin, 300308 CHINA

Re: K172267

Trade/Device Name: IRENE Thoracolumbar Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: February 8, 2018 Received: February 8, 2018

Dear Changli Ou:

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 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K172267

Device Name

IRENE Thoracolumbar Fixation System

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

### Indications for Use (Describe)

IRENE Thoracolumbar Fixation System provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: ( ) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

| <span style="text-decoration: underline;"></span> | <span> <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# Section 7 - 510 (k) Summary

#### Date Prepared: Oct. 13th, 2017 A.

#### B. Submitter and Owner

Tianjin Zhengtian Medical Instrument Co., Ltd. No. 318, Jingyi Road, Airport Economic Zone, Tianjin, 300308, P. R. China Official Correspondent: Xiang Zhaojun, Regulatory Affairs Supervisor Tel: [phone] E-mail: [e-mail] Submission Contact: Ou, Changli, Regulatory Affairs Specialist Tel: [phone] Email: ouchangli(@naton.cn

Establishment Registration Number: 3010227982

#### C. Proposed Device

Propriety Name: IRENE Thoracolumbar Fixation System Common Name: Thoracolumbar Fixation System Classification: 21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System, Class II Product Code: NKB

#### Predicate Device D.

Trade Name: Devine Spinal System 510(k) Number: K111690 Classification Regulation: 21 CFR 888.3070 Product Code: MNH. MNI Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd

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#### E. Indications for Use

IRENE Thoracolumbar Fixation System provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

#### F. Device Description

The proposed device consists of pedicle screws, reduction screws, titanium rods and transverse connectors in various sizes, providing immobilization and stabilization of spinal segments through bridge connection between these components.

The proposed device is made of titanium alloy per ASTM F136, and is intended for single-use.

The proposed device includes three sub-systems, which are named as PLATINUM 5.5M Thoracolumbar Fixation System (NS2), TITANTM 5.5mm Thoracolumbar Fixation System and PLATINUM 6.35 Thoracolumbar Fixation System (NS3), all the devices use the same material and similar design principle, there are slight differences in design and parts size among these three sub-systems which does not raise different questions of safety and effectiveness. There is no surface modification or coating.

The proposed devices are supplied non-sterile. It is required to be sterilized via moist heat to reach a SAL of 106 prior to surgery. The sterilization method is presented in the instructions for use, which has been validated per ISO 17665-1.

#### G. Technological Characteristic Comparison

The Propose device is found to possess similar technological characteristics under the premises of sharing same intended use after comparing design, material, composition and other aspects, the detailed information is listed in Substantial Equivalence Discussion.

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#### H. Performance Data

## Mechanical Testing

Bench tests have been conducted to compare the mechanical properties of the proposed and predicate device according to:

ASTM F1717-15, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Three tests including static axial compression, dynamic axial compression, and static torsion were conducted according to the methods stipulated in above standard, results indicate that the mechanical properties of proposed device are no lower than that of the predicate device.

## Clinical Studies

No clinical data is presented in this submission

#### I. Conclusion

Based on the technological characteristics and non-clinical performance data, IRENE Thoracolumbar Fixation System is as safe and effective as the predicate device due to same intended use and similar technical characteristics.