Posterior Spinal Fixation System

K201737 · Shanghai Reach Medical Instrument Co, Ltd. · NKB · Jun 21, 2021 · Orthopedic

Device Facts

• Record ID: K201737
• Device Name: Posterior Spinal Fixation System
• Applicant: Shanghai Reach Medical Instrument Co, Ltd.
• Product Code: NKB · Orthopedic
• Decision Date: Jun 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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; pseudarthrosis; and/or failed previous fusion.

Device Story

Posterior Spinal Fixation System is a single-use surgical implant system for thoracolumbar spine stabilization and fusion. Components include pedicle screws, rods, and interconnecting devices made of titanium alloy (Ti-6Al-4V). System includes sets for open (RS8 LEGEND) and minimally invasive (RS8 LONG) surgery. Used in hospital settings by surgeons to provide internal fixation; implants are removed after stabilization is achieved. Device provides mechanical support to spinal segments to facilitate fusion. Benefits include stabilization of the spine in patients with degenerative, traumatic, or structural spinal conditions.

Clinical Evidence

No clinical study data submitted. Bench testing performed per ASTM F1717-18 and ASTM F1798-13 to evaluate static/dynamic compression, static tensile, static torsion, and interconnection mechanisms.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ISO 5832-3, GB/T 13810-2007. Surgical instruments: Stainless steel (17-4 PH), silica gel, POM, aluminum alloy. Components are anodized. Provided non-sterile; requires manual cleaning and steam sterilization. System includes pedicle screws, rods, and interconnecting devices for thoracolumbar fixation.

Indications for Use

Indicated for posterior, non-cervical spinal fixation as an adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, or failed previous fusion.

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

• CD HORIZON® Spinal System (K130646)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of an eagle, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.

June 21, 2021

Shanghai REACH Medical Instrument Co., Ltd Mingsha Ye Registration Manager Building 13, No. 999 Jiangyue Road, Minhang Shanghai, 201112 China

Re: K201737/S001

Trade/Device Name: Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 24, 2020 Received: June 25, 2020

Dear Mingsha Ye:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K201737

#### Device Name Posterior Spinal Fixation System

### Indications for Use (Describe)

The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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); tumor; pseudarthrosis; and/or failed previous fusion.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________

# 510(k) Summary

| 510(k) Number: | K201737 | | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date: | December 28, 2020 | | |
| Submitter: | Shanghai REACH Medical Instrument Co., Ltd<br>Building 13,No.999 Jiangyue Road, Minhang District, 201114 Shanghai, PEOPLE'S<br>REPUBLIC OF CHINA<br>Establishment Registration Number: 3015487912 | | |
| Primary Contact: | Mingsha Ye, Registration Manager<br>Shanghai Reach Medical Instrument Co., Ltd<br>Building 13,No.999 Jiangyue Road, Minhang District, 201114 Shanghai, PEOPLE'S<br>REPUBLIC OF CHINA<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] | | |
| Subject Device: | Trade Name | Posterior Spinal Fixation System | |
| | Common Name | Thoracolumbosacral Pedicle Screw System | |
| | Regulation Number | 21 CFR 888.3070 | |
| | Classification Name | Thoracolumbosacral Pedicle Screw System | |
| | Regulatory Class | Class II | |
| | Product Codes | NKB | |
| | Regulation Medical Specialty | Orthopedic | |
| | 510(k) Review Panel | Orthopedic | |
| Predicate Device: | Manufacturer | Medtronic Sofamor Danek USA, Inc. | |
| | Trade Name | CD HORIZON® Spinal System | |
| | 510(k) Number | K130646 | |
| | Regulation Number | 21 CFR 888.3070 | |
| | Regulation Name | Thoracolumbosacral Pedicle Screw System | |
| | Regulatory Class | Class II | |
| | Product Codes | NKB, KWP, KWQ, MNH, MNI | |
| | Regulation Medical Specialty | Orthopedic | |
| | 510(k) Review Panel | Orthopedic | |
| FDA Guidance Documents | The following FDA guidance documents were consulted to prepare this premarket<br>notification:<br>Guidance for Industry and FDA Staff: Spinal System 510(k)s, issued May 3, 2004 Guidance on Medical Device Patient Labeling, issued April 19, 2001 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016 Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, issued December 11, 2014 | | |
| Intended Use /<br>Indications for Use | The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as<br>an adjunct to fusion for the following indications: degenerative disc disease (defined<br>as back pain of discogenic origin with degeneration of the disc confirmed by history<br>and radiographic studies); Spondylolisthesis; trauma (i.e., fracture or dislocation);<br>spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor;<br>pseudarthrosis; and/or failed previous fusion. | | |
| Device Description | The Posterior Spinal Fixation System is a single-use system for surgical fixation of the<br>spine. It is made up of pedicle screws, rods, and interconnecting devices. The<br>implanted parts confer stabilization and fusion of two or more spinal segments and are<br>to be removed once their stabilizing function is no longer required. The implantable<br>devices are manufactured from titanium alloy and are provided non-sterile. | | |
| | The Posterior Spinal Fixation System includes the following sets:<br>RS8 LEGEND (designed for open surgery) RS8 LONG (designed for minimally invasive surgery) | | |
| | Each set comprises of different rods, screws, set screws, and accessory parts, including<br>various lengths and diameters of reduction screws. Both sets are designed for internal<br>posterior thoracolumbar fixation of the spine. Patient diagnosis and individual<br>conditions should be taken into consideration when selecting the surgical option. | | |
| Mechanism of Action | The Posterior Spinal Fixation System is a medical device system for surgical fixation<br>of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The<br>implanted parts confer stabilization and fusion of two or more spinal segments and are<br>to be removed once their stabilizing function is no longer required. | | |
| Applicant | Shanghai REACH Medical Instrument,<br>Co., Ltd. | Medtronic Sofamor Danek USA, Inc. | |
| Device Name | Posterior Spinal Fixation System | CD HORIZON® Spinal System | |
| Intended Use /<br>Indications for Use | The Posterior Spinal Fixation System is<br>intended for posterior, non-cervical<br>fixation as an adjunct to fusion for the<br>following indications: degenerative disc<br>disease (defined as back pain of discogenic<br>origin with degeneration of the disc<br>confirmed by history and radiographic<br>studies); Spondylolisthesis; trauma (i.e.,<br>fracture or dislocation); spinal stenosis;<br>curvatures (i.e., scoliosis, kyphosis and/or<br>lordosis); tumor; pseudarthrosis; and/or<br>failed previous fusion. | The CD HORIZON® Spinal System<br>with or without SEXTANT®<br>instrumentation is intended for posterior,<br>non-cervical fixation as an adjunct to<br>fusion for the following indications:<br>degenerative disc disease (defined as<br>back pain of discogenic origin with<br>degeneration of the disc confirmed by<br>history and radiographic studies);<br>Spondylolisthesis; trauma (i.e., fracture<br>or dislocation); spinal stenosis;<br>curvatures (i.e., scoliosis, kyphosis<br>and/or lordosis); tumor; pseudarthrosis;<br>and/or failed previous fusion.<br>Except for hooks, when used as an<br>anterolateral thoracic/lumbar system, the<br>CD HORIZON® Spinal System may<br>also be used for the same indications as<br>an adjunct to fusion.<br>With the exception of degenerative disc<br>disease, the CD HORIZON®<br>LEGACY™ 3.5mm rods and the CD<br>HORIZON® Spinal System PEEK rods<br>and associated components may be used<br>for the aforementioned indications in<br>skeletally mature patients as an adjunct<br>to fusion. The 3.5mm rods may be used<br>for the specific pediatric indications<br>below. | |
| | | When used for posterior non-cervical<br>pedicle screw fixation in pediatric<br>patients, the CD HORIZON® Spinal<br>System implants are indicated as an<br>adjunct to fusion to treat adolescent<br>idiopathic scoliosis. Additionally, the<br>CD HORIZON® Spinal System is<br>intended to treat pediatric patients<br>diagnosed with the following conditions:<br>Spondylolisthesis/spondylolysis and<br>fracture caused by tumor and/or trauma.<br>These devices are to be used with<br>autograft and/or allograft. Pediatric<br>pedicle screw fixation is limited to a<br>posterior approach. | |
| | | The CD HORIZON SPIRE™ Plate is a<br>posterior, single level, non-pedicle<br>supplemental fixation device intended<br>for use in the non-cervical spine (T1-S1)<br>as an adjunct to fusion in skeletally<br>mature patients. It is intended for plate<br>fixation/attachment to spinous processes<br> | |
| | |…