ORTHROS POSTERIOR STABILIZATION SYSTEM

K133366 · Camber Spine · NKB · Apr 8, 2014 · Orthopedic

Device Facts

• Record ID: K133366
• Device Name: ORTHROS POSTERIOR STABILIZATION SYSTEM
• Applicant: Camber Spine
• Product Code: NKB · Orthopedic
• Decision Date: Apr 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Orthros Posterior Stabilization System is 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 thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, Orthros Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

Device Story

Orthros Posterior Stabilization System is a pedicle screw system used for spinal immobilization and stabilization. The system consists of titanium alloy (ASTM F136) rods, monoaxial screws, polyaxial screws, and locking caps, along with manual surgical instruments. The device is used by surgeons in an operating room setting. Components are configured and rigidly locked to the patient's spine to provide stability as an adjunct to fusion. The system supports the spine during the healing process, potentially benefiting patients by correcting deformities or stabilizing instabilities. The device is non-sterile and requires autoclaving before use.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including static axial compression, static axial torsion, and dynamic axial compression per ASTM F1717-13, and screw pullout testing per ASTM F543-07.

Technological Characteristics

Implants are manufactured from Titanium Alloy (ASTM F136). Instruments are manufactured from medical grade stainless steels (303, 17-4, 420, 455, 465) and aluminum (6061-T2). The system is a mechanical pedicle screw spinal system consisting of rods, monoaxial/polyaxial screws, and locking caps. It is non-sterile and autoclaveable (SAL 10^-6 per ISO 17665).

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for thoracic, lumbar, and sacral/iliac (T1-S1/Ilium) instabilities or deformities including degenerative disc disease, degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and pseudarthrosis. Also indicated for severe (Grade 3-4) L5-S1 spondylolisthesis with autogenous bone graft, with fixation levels L3-sacrum/ilium.

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

• Corelink Tiger Spine System (K121728)
• Globus Medical Revere Stabilization System (K061202)
• Globus Medical Creo Stabilization System (K124058)
• Medtronic CD Horizon Legacy 4.5mm System (K113395)
• Synthes Pagea Monoaxial System (K052151)

Submission Summary (Full Text)

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K133366 - Page 1 of 4

Image /page/0/Picture/2 description: The image is a logo for Camber Spine Technologies. The logo consists of a stylized letter "C" in a black square on the left, and the words "Camber Spine Technologies" on the right. The words "Camber" and "Spine" are stacked on top of each other, and the word "Technologies" is below them.

## 510(k) Summary Traditional 510k

as required by section 807.92(c).

## Orthros Posterior Stabilization System K133366 Prepared 3/5/14

| Submitter: | Camber Spine |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 90 S. Newtown Street Rd., Suite #10 |
| | Newtown Square, PA 19073 |
| Contact Person | Dan Pontecorvo |
| | President |
| | Phone: [phone], Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | Orthros Posterior Stabilization System |
| Common Name | Pedicle Screw System |
| Device Class | Class III |
| Classification Name<br>and Number | Orthosis, Spondylolistheses Spinal System , 21 CFR 888.3070<br>Orthosis, Spinal Pedicle Fixation, 21 CFR 888.3070 |
| Classification Panel: | Orthopedic |
| Product Code | NKB , MNI , MNH, KWQ |
| Reason for 510k | New Device |
| Predicate Devices | Corelink Tiger Spine System (K121728), Globus Medical Revere |
| | Stabilization System (K061202), Globus Medical Creo Stabilization |
| | System (K124058), Medtronic CD Horizon Legacy 4.5mm System |
| | (K113395) and Synthes Pagea Monoaxial System (K052151) |
| Device Description | Orthros Posterior Stabilization System consist of a variety of shapes<br>and sizes of rods, monoaxial screws, polyaxial screws, locking caps<br>and associated manual surgical instruments. Implant components can<br>be rigidly locked into a variety of configurations for the individual<br>patient and surgical condition. Polyaxial screws are intended for<br>posterior and anterior use. Rods and monoaxial screws may be used<br>anteriorly or posteriorly. Locking caps and locking set screws are used<br>to connect screws to the rod. The rods are composed of titanium<br>alloy, as specified in ASTM F136. All other implants are composed of<br>titanium alloy, as specified in ASTM F136. |
| Intended Use | Orthros Posterior Stabilization System is intended to provide<br>immobilization and stabilization of spinal segments in skeletally<br>mature patients as an adjunct to fusion in the treatment of the<br>following acute and chronic instabilities or deformities of thoracic,<br>lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease<br>(defined as discogenic back pain with degeneration of disc confirmed<br>by history and radiographic studies), degenerative spondylolisthesis<br>with objective evidence of neurological impairment, fracture,<br>dislocation, scoliosis, kyphosis, spinal tumor, and failed previous<br>fusion (pseudarthrosis).<br>In addition, Orthros Posterior Stabilization System is intended for<br>treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1<br>vertebra in skeletally mature patients receiving fusion by autogenous<br>bone graft, having implants attached to the lumbosacral spine and/or<br>ilium with removal of the implants after attainment of a solid fusion.<br>Levels of pedicle screw fixation for these patients are L3-<br>sacrum/ilium. |
| Materials: | All implants are manufactured out of Titanium Alloy, specifically TAV-<br>per ASTM F136. Supporting instrumentation is manufactured out of<br>medical grade Stainless Steels including: 303, 17-4, 420, 455 & 465<br>alloys. Aluminum, specifically 6061-T2 is also used on some<br>instruments. |

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K133366 - Page 3 of 4

·

1

| | Orthros Posterior Stabilization System and its predicate devices have the |
|---------------|----------------------------------------------------------------------------|
| Statement of | same indications for use, similar design, principles of operation and test |
| Technological | results. Both devices are manufactured using materials with a long |
| Comparison | history of use in orthopedic implants. |

| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the Orthros Posterior<br>Stabilization System<br>System is substantially equivalent to other predicate devices.<br>Static Axial Compression Bend Test per ASTM F1717-13 Static Axial Torsion Test per ASTM F1717-13 Dynamic Axial Compression Bend Test per ASTM F1717-13 Screw Pullout Testing per ASTM F543-07 The results of these studies showed that the Orthros Posterior Stabilization System met<br>the acceptance criteria. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test<br>Summary | No clinical tests were performed. |

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and the control of the country of

| Sterilization Information | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implants | The Implant will be shipped non-sterile and will be autoclaveable, validation testing of<br>the process was conducted (using the half-cycle method) to a Sterility Assurance Level<br>(SAL) of 10-6 per ISO 17665. |
| Instruments and<br>Case | The instrument and case will be shipped non-sterile and will be autoclaveable,<br>validation testing of the process was conducted (using the half-cycle method) to a<br>Sterility Assurance Level (SAL) of 10-6 per ISO 17665. |

| Conclusion | The Orthros Posterior Stabilization System is substantially equivalent to its predicate devices. This conclusion is based upon the fact the Orthros Posterior Stabilization System and its predicate devices have the same indications for use, have a similar design, principles of operation and technical characteristics, similar test results, and any differences do not raise new questions of safety and effectiveness. |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

1. September 2017 11:40

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 8, 2014

Camber Spine Technologies Mr. Daniel A. Pontecorvo President 90 South Newton Street Road, Suite 10 Newton Square, Pennsylvania 19073

Re: K133366

Trade/Device Name: Orthros Posterior Stabilization System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWO Dated: March 6, 2014 Received: March 7, 2014

Dear Mr. Pontecorvo:

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 device-related 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.

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Page 2 - Mr. Daniel A. Pontecorvo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

### 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) K133366

Device Name

Orthros Posterior Stabilization System

#### Indications for Use (Describe)

Orthros Posterior Stabilization System is intended to provide immobilization 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 thoracic, lumbar, and sacral/iliac spine (TI-S1/Ilium): degenerative discogenic back pain with degeneration of disconfirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, Orthros Posterior System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

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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