K Number
K163422
Device Name
Shanghai Sanyou PEEK Cage System
Date Cleared
2017-09-18

(286 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5. The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use. The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.
Device Description
The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices: - Caro™ Cervical Cage System - Halis™ Lumbar Cage System - Lydia™ Anterior Lumbar Fusion System - . Dica™ Direction Changeable Lumbar Cage System All components are made of polyetheretherketone (PEEK). All fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical or lumbar spine. These Fusion Devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during intervertebral body fusion surgeries. All components have serrations on the superior and inferior surfaces of the implant to aid in fixation. The hollow geometry of the implants allows them to be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Radiopaque Markers manufactured from unalloyed tantalum have been embedded within the implant to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of device.
More Information

No
The device description and intended use focus on the physical characteristics and function of a PEEK cage system for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.

Yes

The device is a PEEK cage system designed to promote bone fusion and stabilize the spine in patients with degenerative disc disease, which clearly falls under the definition of a therapeutic intervention.

No

Explanation: The provided text describes the Shanghai Sanyou PEEK Cage System as an implantable device intended for spinal fusion, promoting bone fusion and providing support. It does not perform diagnostic functions; rather, it is a treatment device.

No

The device description clearly states that the device consists of physical components made of PEEK and tantalum, which are implanted into the spine. This is a hardware medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The provided text clearly describes the Shanghai Sanyou PEEK Cage System as a collection of implantable devices (cages) used for spinal fusion surgery. Their purpose is to provide structural support and promote bone fusion within the patient's body.
  • Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens outside of the body.

The device is a surgical implant used for treatment, not a diagnostic tool that analyzes samples.

N/A

Intended Use / Indications for Use

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

Product codes (comma separated list FDA assigned to the subject device)

ODP, MAX

Device Description

The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices:

  • Caro™ Cervical Cage System
  • Halis™ Lumbar Cage System
  • Lydia™ Anterior Lumbar Fusion System
  • . Dica™ Direction Changeable Lumbar Cage System

All components are made of polyetheretherketone (PEEK). All fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical or lumbar spine. These Fusion Devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during intervertebral body fusion surgeries. All components have serrations on the superior and inferior surfaces of the implant to aid in fixation. The hollow geometry of the implants allows them to be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Radiopaque Markers manufactured from unalloyed tantalum have been embedded within the implant to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine, lumbar spine (L2-S1, C2-T1)

Indicated Patient Age Range

skeletally mature

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Static and dynamic axial compression, static shear compression, static torsion and were completed for the Shanghai Sanyou PEEK Cage System according the ASTM F2077-14 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004. Additionally, subsidence testing was completed according to ASTM F2267-04. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K132897 – Medtronic Clydesdale® Spinal System, K072791 - Depuy Synthes Spine, OPAL Spacer, K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System, K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal System, K153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cervical Fusion System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K150765, ROI-C Fusion System, K121982, Sovereign Spinal System

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a representation of human figures.

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

September 18, 2017

Shanghai Sanyou Medical Co, Ltd % Christine Scifert Executive Vice President MRC/X, LLC 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119

Re: K163422

Trade/Device Name: Shanghai Sanyou PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: August 25, 2017 Received: August 30, 2017

Dear Ms. Scifert:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

Indications for Use

510(k) Number (if known) K163422

Device Name Shanghai Sanyou PEEK Cage System

Indications for Use (Describe)

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogence back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

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.

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4

510(k) Summary

Shanghai Sanyou PEEK Cage System September 8, 2017

| Company: | Manufacturing Facility and Headquarters:
Shanghai Sanyou Medical Co, LTD
1988 Jiatang Road
Jiading District, Shanghai, 201807, China |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturing Facility:
Shanghai Sanyou Medical Co, LTD
Rm 101/102/106/107
356 Renqing Rd, Building 3-1F,
Pudong New District, Shanghai 201201, China |
| Primary Contact: | Christine Scifert
Phone: 901-831-8053
christine.scifert@mrc-x.com |
| Company Contact: | David Fan, VP, Marketing
Phone: +86 21 58389980
Fax: +86 21 38682915
david.fan@sanyou-medical.com |
| Trade Name: | Shanghai Sanyou PEEK Cage System |
| Common Name: | Intervertebral Body Fusion Device with Bone Graft, Cervical
Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral Body Fusion Device) |
| Panel: | 87- Orthopedic |
| Product Code: | ODP, MAX |
| Primary
Predicate Device: | K132897 – Medtronic Clydesdale® Spinal System |
| Additional Predicate
Devices: | K072791 - Depuy Synthes Spine, OPAL Spacer
K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System
K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal System
K153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cervical Fusion
System |

5

Device Description:

The Shanghai Sanyou PEEK Cage System consists of four different models of fusion devices:

  • Caro™ Cervical Cage System
  • Halis™ Lumbar Cage System
  • Lydia™ Anterior Lumbar Fusion System
  • . Dica™ Direction Changeable Lumbar Cage System

All components are made of polyetheretherketone (PEEK). All fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the cervical or lumbar spine. These Fusion Devices consist of PEEK cages of various heights, widths and lengths, which can be inserted between two lumbar or cervical vertebral bodies to give support and correction during intervertebral body fusion surgeries. All components have serrations on the superior and inferior surfaces of the implant to aid in fixation. The hollow geometry of the implants allows them to be packed with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

Radiopaque Markers manufactured from unalloyed tantalum have been embedded within the implant to allow for visualization in radiographic images. Associated instruments are available to facilitate the implantation of device.

Several additional predicates and reference devices are identified and are used to support the substantial equivalence of the individual components of the Shanghai Sanyou PEEK Cage System as described in Table 1 below.

Predicate Devices
Predicate DevicePredicate
UsageSubject Device SupportedRationale for Support
K132897, Clydesdale
Spinal SystemLumbarHalis™ Lumbar Cage SystemEquivalent size range, anatomic
usage, and implantation approach
K072791, OPAL SpacerLumbarHalis™ Lumbar Cage SystemEquivalent size range, anatomic
usage, and implantation approach
K094025, Crescent
Spinal SystemLumbarDica™ Direction Changeable
Lumbar Cage SystemEquivalent size range, anatomic
usage, and implantation approach
K151128, Capstone
Spinal SystemLumbarHalis™ Lumbar Cage SystemEquivalent size range, anatomic
usage, and implantation approach
K153373, Cornerstone
Spinal SystemCervicalCaro™ Cervical Cage SystemEquivalent size range, anatomic
usage, and implantation approach
Reference Devices
Reference DeviceReference
UsageSubject Device SupportedRationale for Support
K150765, ROI-C Fusion
SystemCervicalCaro™ Cervical Cage SystemEquivalent size range, anatomic
usage, and implantation approach
K121982, Sovereign
Spinal SystemLumbarLydia™ Anterior Lumbar
Fusion SystemEquivalent size range, anatomic
usage, and implantation approach

Table 1. Predicate and Reference Devices

6

Indications for Use:

The Halis™ Lumbar Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires use of interbody fusion combined with supplemental fixation. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have had six months of non-operative treatment prior to surgery. The Halis™ Lumbar Cage System is intended to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation. The devices may be implanted through several surgical approaches: transforaminal, posterior, oblique, and direct lateral. When implanted through the direct lateral approach, the Halis™ Lumbar Cage System is only indicated for use in levels L2-L5.

The Caro™ Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to surgery. Caro™ Cervical Cage System implants are placed via an anterior approach and is to be used with autogenous bone graft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are intended to be used with supplemental fixation.

The Lydia™ Anterior Lumbar Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The devices are intended to be used with supplemental fixation. This device is not intended for cervical spine use.

The Dica™ Direction Changeable Lumbar Cage System is indicated for interbody fusion with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six months of non-operative treatment prior to surgery. The devices are intended to be used with supplemental fixation.

Performance Testing:

Static and dynamic axial compression, static shear compression, static torsion and were completed for the Shanghai Sanyou PEEK Cage System according the ASTM F2077-14 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004. Additionally, subsidence testing was completed according to ASTM F2267-04. Performance testing demonstrates that the subject device meets or exceeds performance of predicate devices demonstrating that the subject devices are substantially equivalent to the predicate devices.

7

Substantial Equivalence:

The subject systems components are similar in sizes, materials and geometry to the predicate components. The subject components have the same indications as the predicate components. The subject devices are substantially equivalent to the predicate devices.

K132897 – Medtronic Clydesdale® Spinal System

K072791 – Depuy Synthes Spine, OPAL Spacer

K094025 – Medtronic Sofamor Danek, CRESCENT™ Spinal System

K151128 – Medtronic Sofamor Danek, CAPSTONE® Spinal System

K153373 – Medtronic Sofamor Danek, CORNERSTONE® PSR Cervical Fusion System