IMSE Cervical Cage

K162003 · The Institute of Musculoskeletal Science & Education · ODP · Dec 21, 2016 · Orthopedic

Device Facts

• Record ID: K162003
• Device Name: IMSE Cervical Cage
• Applicant: The Institute of Musculoskeletal Science & Education
• Product Code: ODP · Orthopedic
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.

Device Story

IMSE Cervical Cage is an intervertebral body fusion device designed to maintain disc space distraction in the cervical spine. The device features a hollow center for autogenous bone graft placement and ridges on superior/inferior surfaces to grip endplates and prevent expulsion. It is used in conjunction with supplemental spinal fixation instrumentation (e.g., anterior cervical plates or posterior screws). The device is implanted by a surgeon in a clinical setting. It provides structural support to facilitate fusion, potentially alleviating neck pain of discogenic origin.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Constructed from PEEK (Solvay Zeniva ZA-500, ASTM F2026) with embedded tantalum x-ray markers (ASTM F560). Device is a hollow cage with surface ridges. Shipped non-sterile; validated for autoclave sterilization to SAL 10^-6 per ISO 17665.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis at one level (C3-C7) in the cervical spine, following six weeks of failed non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Camber Spine Coveris Cervical Cage (K133529)

Submission Summary (Full Text)

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

December 21, 2016

The Institute of Musculoskeletal Science & Education Mr. Ed McShane Director of Development 418 E. Lancaster Ave Wayne, Pennsylvania 19087

Re: K162003

Trade/Device Name: IMSE Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 1, 2016 Received: December 1, 2016

Dear Mr. McShane:

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 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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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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

### Vincent J. Devlin -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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### Indications for Use

510(k) Number (if known) K162003

Device Name IMSE Cervical Cage

#### Indications for Use (Describe)

When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C |

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C)

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# Traditional 510(k) Summary

as required by section 807.92(c).

## IMSE Cervical Cage K162003

| Revised | 12/20/16 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | The Institute of Musculoskeletal Science & Education |
| | 418 E. Lancaster Ave. |
| | Wayne, PA 19087 |
| Contact Person | Ed McShane |
| | Director of Development |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | IMSE Cervical Cage |
| Common Name | Intervertebral Body Fusion Device |
| Device Class | Class II |
| Classification Name<br>and Number | Intervertebral fusion device with bone graft, cervical<br>21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | ODP |
| Reason for 510k | New Device |
| Predicate Devices | Camber Spine Coveris Cervical Cage (K 133529) |
| Device Description | The IMSE Cervical Cage series of intervertebral body fusion devices<br>are used to maintain disc space distraction in skeletally mature adults<br>requiring intervertebral body fusion. They are designed to be used in<br>conjunction with supplemental spinal fixation instrumentation. The<br>series is comprised of cages of various fixed heights and shapes for<br>placement in the cervical spine. Each cage has a hollow center to |
| | allow placement of autograft inside of the cage. Ridges on the |
| | superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. |
| | The IMSE Cervical Cage of intervertebral body fusion devices are |
| | made from the PEEK (Solvay Zeniva ZA-500) radiolucent material with |
| | embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively. |

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| Indications for Use | When used as a cervical intervertebral fusion device, the IMSE Cervical Cage<br>is indicated for use at one level in the cervical spine, from C3-C7, in<br>skeletally mature patients who have had six weeks of non-operative<br>treatment for the treatment of degenerative disc disease (DDD) with up to<br>Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin<br>with degeneration of the disc confirmed by history and radiographic<br>studies. The device is intended for use with autogenous bone graft and with<br>supplemental fixation systems (such as anterior cervical plating systems, or<br>posterior screw systems) cleared for use in the cervical spine. |
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| | The implant is manufactured from ASTM2026 Solvay Zeniva |
|------------|---------------------------------------------------------|
| Materials: | ZA-500 implant grade Polyetheretherketone (PEEK) |

| Statement of<br>Technological<br>Comparison | IMSE Cervical Cage and its predicate devices have the same indications for<br>use, design, and test results. Both devices are manufactured using<br>materials with a long history of use in orthopaedic implants. |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the IMSE Cervical Cage is<br>substantially equivalent to other predicate devices. Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear ASTM F2077 Static and Dynamic Torsion ASTM F2077 Subsidence Test per ASTM F2267 Wear Debris ASTM F1877 Static Expulsion Test The results of these studies showed that the IMSE Cervical Cage met the acceptance<br>criteria. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test<br>Summary | No clinical tests were performed. |

| 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 IMSE Cervical Cage is substantially equivalent to its predicate devices. This conclusion is based upon the fact the IMSE Cervical Cage and its predicate devices have the same indications for use, design and technical characteristics, test results, and there are no different questions of safety and effectiveness. |
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