Keos Lumbar IBFD

K163386 · Keos · MAX · Apr 10, 2017 · Orthopedic

Device Facts

• Record ID: K163386
• Device Name: Keos Lumbar IBFD
• Applicant: Keos
• Product Code: MAX · Orthopedic
• Decision Date: Apr 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

Device Story

Intervertebral body fusion device (cage) used to maintain disc space distraction during spinal fusion; implanted via TLIF (single cage) or PLIF (two cages) approach at L2-S1 levels. Device features hollow center for autogenous bone graft; superior/inferior ridges grip endplates to prevent expulsion. Used in conjunction with cleared supplemental spinal fixation systems (pedicle screws, plates, rods). Intended for use in surgical settings by orthopedic or neurosurgeons. Benefits include spinal stabilization and fusion support for patients with discogenic pain.

Clinical Evidence

No clinical data.

Technological Characteristics

Materials: PEEK-OPTIMA and PEEK-OPTIMA LT120HA (ASTM F2026); tantalum x-ray markers (ASTM F560). Form factor: Cages of various fixed heights/shapes. Sterilization: Non-sterile, autoclaveable (ISO 17665, SAL 10^-6).

Indications for Use

Indicated for spinal fusion at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis or retrolisthesis. Includes patients with prior non-fusion spinal surgery. Requires 6 months 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

• Keos Lumbar IBFD (K160631)

Submission Summary (Full Text)

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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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a stacked, flowing manner.

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

April 10, 2017

Keos Mark Schenk Director of QA/RA 1824 Colonial Village Lane Lancaster, Pennsylvania 17601

Re: K163386

Trade/Device Name: Keos Lumbar IBFD Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 15, 2017 Received: March 17, 2017

Dear Mr. Schenk:

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

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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,

# Mark N. Melkerson -S

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) K163386

Device Name Keos Lumbar IBFD

#### Indications for Use (Describe)

Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft.

Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Keos Lumbar IBFD can be used in one of two methods:

Transforaminal Lumbar Interbody Fusion (TLIF)

Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforminal approached surgery.

Posterior Lumbar Interbody Fusion (PLIF)

Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

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

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## Traditional 510(k) Summary

as required by section 807.92(c).

| Submitter: | Keos<br>1824 Colonial Village Lane<br>Lancaster, PA 17601 |
|----------------|-----------------------------------------------------------|
| Contact Person | Mark F Schenk |
| | Director of QA/RA |
| | Phone: [phone] |
| | Email: [e-mail] |
| Date Updated | 4/7/17 |

| Trade Name | Keos Lumbar IBFD |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Intervertebral body fusion device |
| Device Class | Class II |
| Classification Name<br>and Number | Intervertebral Fusion Device With Bone Graft, Lumbar<br>intervertebral fusion device with bone graft, cervical<br>21 CFR 888.3080 |
| Classification Panel: | Orthopedic |
| Product Code | MAX |
| Reason for 510k | Update Cleaning Instructions |
| Predicate Devices | K160631, Keos Lumbar IBFD |

| Device Description | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The series of intervertebral body fusion devices are used to maintain<br>disc space distraction in skeletally mature adults requiring<br>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 spine. There are different cages designed for<br>specific regions of the spine and approaches to the spine. Each cage<br>has a hollow center to allow placement of graft material inside of the<br>cage. Ridges on the superior and inferior surfaces of the device help<br>to grip the endplates and prevent expulsion. |
| | The series of intervertebral body fusion devices are made from the<br>PEEK radiolucent material and HA enhanced PEEK with embedded<br>tantalum x-ray markers as specified in ASTM F2026 and ASTM F560,<br>respectively. |

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| Indications for Use | Keos Lumbar IBFD is indicated for spinal fusion procedure at one<br>or two contiguous levels (L2-S1) in skeletally mature patients<br>with degenerative disc disease (DDD). DDD is defined as<br>discogenic pain with degeneration of the disc confirmed by<br>patient history and radiographic studies. DDD may also have up |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Keos Lumbar IBFD is intended to be used with supplemental<br>spinal fixation systems that have been cleared for lumbosacral<br>spine (i.e. posterior pedicle screws and rod systems, anterior<br>plate systems, and anterior screw and rod systems). The<br>device(s) is intended to be used with autogenous bone graft. |
| | Patients should have at least six (6) months of non-operative<br>treatment prior to treatment with an intervertebral cage. |
| | The Keos Lumbar IBFD can be used in one of two methods: |
| | Transforaminal Lumbar Interbody Fusion (TLIF)<br>Used as a TLIF, a single device is implanted in the appropriate<br>location (L2-S1) to provide support for a transforaminal<br>approached surgery. |
| | Posterior Lumbar Interbody Fusion (PLIF)<br>Used as a PLIF, two devices are implanted in the appropriate<br>locations (L2-S1) to provided support to the spine for a posterior<br>surgery. |

| | Materials: | The implant is manufactured from ASTM F2026 implant grade PEEK-<br>OPTIMA and PEEK-OPTIMA LT120HA (PEEK-OPTIMA HA Enhanced). |
|--|------------|------------------------------------------------------------------------------------------------------------------------------|
|--|------------|------------------------------------------------------------------------------------------------------------------------------|

| Statement of<br>Technological<br>Comparison | Keos Lumbar IBFD and its predicate devices have the same indications for use, same design, and test results. The purpose of this submission is to document the cleaning validation for the previously cleared devices. |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Nonclinical Test<br>Summary | The following tests were performed to demonstrate that the Keos Lumbar IBFD is<br>substantially equivalent to other predicate devices.<br><br>Static and Dynamic Compression Test per ASTM F2077 X-ray Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), and X-<br>ray photoelectron Spectroscopy (XPS) were used to evaluate the effects of<br>cleaning on the implants. The results of these studies showed that the Keos Lumbar IBFD met the acceptance<br>criteria. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test<br>Summary | No clinical tests were performed. |

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

| | The Keos Lumbar IBFD is substantially equivalent to its predicate devices. This |
|------------|------------------------------------------------------------------------------------------|
| Conclusion | conclusion is based upon the fact the Keos Cage and its predicate devices have the |
| | same indications for use, have a same design and technical characteristics, similar test |
| | results, and any differences do not raise question of safety and effectiveness. |