Tyber Medical PT Interbody Spacer

K182284 · Tyber Medical, LLC · ODP · Jan 18, 2019 · Orthopedic

Device Facts

• Record ID: K182284
• Device Name: Tyber Medical PT Interbody Spacer
• Applicant: Tyber Medical, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jan 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cervical System Indications: The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.

Device Story

Interbody fusion device; used in cervical spine (C2-T1) to stabilize vertebral segments. Implanted by surgeons during spinal fusion procedures; requires supplemental fixation. Device consists of PEEK-Optima spacer with plasma-sprayed commercially pure titanium coating. Filled with autograft or allogenic bone graft to promote fusion. New configurations feature larger inclination angles and extra-large sizes; open lumen and surface teeth geometry remain consistent with existing system. Used in clinical settings (OR). Benefits patient by providing structural support and facilitating fusion in cases of instability, trauma, or degenerative disease.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing including static and dynamic compression, compression-shear, and torsion testing per ASTM F2077, plus expulsion testing and pyrogenicity testing per ST72:2011.

Technological Characteristics

Materials: PEEK-Optima with plasma-sprayed commercially pure titanium coating. Trials: stainless steel. Mechanical testing: ASTM F2077 (static/dynamic compression, compression-shear, torsion). Biocompatibility: Pyrogenicity per ST72:2011. Form factor: Interbody spacer with open lumen and surface teeth.

Indications for Use

Indicated for skeletally mature patients with cervical disc disease (radiculopathy/myelopathy, herniated disc, osteophyte formation), instability, trauma (fractures), deformity (kyphosis, lordosis, scoliosis), cervical spondylotic myelopathy, spinal stenosis, or failed previous fusion at C2-T1. Requires 6 weeks of prior 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

• Tyber Medical PT Interbody System (K180590)
• Nuvasive (K163491)
• Globus (K173722)
• Tyber Medical Interbody System (K130573)
• Tyber Medical PT Interbody Line Extension (K172185)

Submission Summary (Full Text)

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February 25, 2019

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Tyber Medical LLC Mark Schenk Vice President of Regulatory and Quality 83 South Commerce Way, Suite 310 Bethlehem, Pennsylvania 18017

Re: K182284

Trade/Device Name: Tyber Medical PT Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 13, 2018 Received: December 18, 2018

Dear Mark Schenk:

This letter corrects our substantially equivalent letter of January 18, 2019.

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Katherine D. Kavlock -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) K182284

#### Device Name

Tyber Medical PT Interbody Spacer System

### Indications for Use (Describe)

Cervical System Indications:

The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Traditional 510(k) Summary

## TYBER MEDICAL PT Interbody Spacer System K182284

| Submitted by | Tyber Medical, LLC<br>83 South Commerce Way<br>Suite 310<br>Bethlehem, PA 18017 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mark F. Schenk<br>Vice President of Regulatory and Quality<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | January 16, 2019 |
| Common Names | Interbody Spacer System |
| Trade Name | Tyber Medical PT Interbody Spacer System |
| Classification Name<br>and Number | Intervertebral body fusion device<br>(21 CFR 888.3080) |
| Product Code | ODP |
| Primary Predicate | Tyber Medical PT Interbody System (K180590), |
| Additional Predicate<br>Devices | Nuvasive (K163491), Globus (K173722), Tyber Medical Interbody<br>System (K130573) and Tyber Medical PT Interbody Line Extension<br>(K172185) |
| Device Description | This submission is to add additional ACIF configurations to the Tyber<br>Medical PT Interbody System and corresponding trials. Additionally,<br>the Indications for Use are being revised.<br><br>The new configurations will be manufactured from PEEK – Optima®<br>and plasma sprayed with commercially pure titanium coating,<br>identical to the existing devices in the system. The new ACIF<br>configurations have superior and inferior surfaces that are inclined at<br>larger angles than the existing configurations. In addition, a new extra-<br>large configuration for these sizes will be included. Other geometries,<br>such as the open lumen area and teeth geometry on the superior and<br>inferior surfaces remain identical to the devices within the Tyber<br>Medical PT Interbody System.<br><br>The trials will be manufactured from stainless steel and will<br>incorporate trial geometries that match the corresponding implant. |
| Intended Use/<br>Indications for use | Cervical System Indications: |
| | The Tyber Medical PT Cervical Interbody Spacers are interbody fusion<br>devices indicated at one or more levels of the cervical spine C2-T1 in<br>patients with cervical disc disease, instability, trauma including<br>fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical<br>spondylotic myelopathy, spinal stenosis, and failed previous fusion.<br>Cervical disc disease is defined as intractable radiculopathy and/or<br>myelopathy with herniated disc and/or osteophyte formation on<br>posterior vertebral endplates producing symptomatic nerve root<br>and/or spinal cord compression confirmed by radiographic studies.<br>These patients should be skeletally mature and have had at least six<br>(6) weeks of non-operative treatment. |
| | Tyber Medical PT Cervical Interbody spacers are to be filled with<br>autograft bone and/or allogenic bone graft composed of cancellous,<br>cortical, and/or corticocancellous bone. These devices are intended to<br>be used with supplemental fixation. |
| Performance Data<br>(Non-Clinical) | The following tests were performed on the Tyber Medical PT Interbody<br>Spacer and the results were compared to the previously cleared 510k<br>K130573. |
| | Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear per ASTM F2077 Static and Dynamic Torsion per ASTM F2077 Expulsion Testing Pyrogenicity testing was performed per ST72:2011. |
| Performance Data<br>(Clinical) | Clinical data and conclusions were not needed for this device. |

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| Statement of<br>Technological<br>Comparison | The Tyber Medical PT Interbody System and its predicate devices have<br>the same design; are made of identical materials, have similar<br>applications, and indications, and have equivalent anatomic<br>mechanical properties. |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Conclusion | The new configurations are substantially equivalent to the devices in the<br>Tyber Medical PT Interbody System, based on design, material, indications<br>and test results. Additionally, the Tyber Medical PT Interbody devices are<br>similar in design and material to the additional predicate devices. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Tyber Medical PT Interbody devices included in this submission, do not<br>raise any additional risk to safety and effectiveness. |