Tyber Medical PT Interbody Spacer System

K180590 · Tyber Medical, LLC · ODP · Jul 6, 2018 · Orthopedic

Device Facts

• Record ID: K180590
• Device Name: Tyber Medical PT Interbody Spacer System
• Applicant: Tyber Medical, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jul 6, 2018
• 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 Interbody Spacer System is indicated for use as an intervertebral body fusion device in sketally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to faciliate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used. Lumbar System Indications: The Tyber Medical PT Interbody Spacer System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

Device Story

Intervertebral body fusion device; PEEK-Optima LT1 core with plasma-sprayed commercially pure titanium coating; open architecture for bone graft packing; superior/inferior surface teeth for migration prevention. Surgically implanted by orthopedic or neurosurgeons in hospital setting. Facilitates spinal fusion in cervical or lumbar spine; requires supplemental fixation. Benefits patient by stabilizing spinal segment and promoting fusion in degenerative disc disease or deformity cases.

Clinical Evidence

No clinical data provided; clinical data and conclusions were not needed for this device. Bench testing only.

Technological Characteristics

Materials: PEEK-Optima LT1 with plasma-sprayed commercially pure titanium. Form factor: Various footprints, heights, and lordotic configurations with open architecture and surface teeth. MR safety testing performed per ASTM F2052-15, ASTM F2119-07, ASTM F2213-06, ASTM F2503-13, and ASTM F2182-11a.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain) at one cervical level (C2-T1) or one/two contiguous lumbar levels (L2-S1). Lumbar patients may have Grade 1 spondylolisthesis/retrolisthesis or prior non-fusion surgery. Also indicated for spinal deformities as an adjunct to fusion. Requires six 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 Spacer System (172185)
• DPS Concorde Bullet Lumbar Interbody (K151773)
• Aesculap Plasmapore XP Spinal System (K132421)
• DPS T-PAL Spacer System (K162358)
• Medtronic Anatomic PEEK PTC Cervical Fusion System (K133653)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & Drug Administration. The Department of Health and Human Services logo is on the left and consists of a stylized caduceus. The U.S. Food & Drug Administration logo is on the right and consists of 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: K180590

Trade/Device Name: Tyber Medical PT Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MAX Dated: June 4, 2018 Received: June 8, 2018

Dear Mark 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

July 6, 2018

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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,

# Brent Showalter -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) K180590

#### Device Name

Tyber Medical PT Interbody Spacer System

#### Indications for Use (Describe)

Cervical System Indications:

The Tyber Medical PT Interbody Spacer System is indicated for use as an intervertebral body fusion device in sketally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to faciliate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used.

#### Lumbar System Indications:

The Tyber Medical PT Interbody Spacer System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| | <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) Summary

### Tyber Medical PT Interbody Spacer System

### K180590

| 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 | July 6, 2018 |
| Common Names | Interbody Spacer System |
| Trade Name | Tyber Medical PT Interbody Spacer System |
| Classification Name<br>and Number | Intervertebral body fusion<br>device (21 CFR 888.3080, Class II) |
| Product Code | ODP and MAX |
| Primary Predicate<br>Device | Tyber Medical PT Interbody Spacer System (172185) |
| Additional Predicates | DPS Concorde Bullet Lumbar Interbody (K151773), Aesculap Plasmapore XP<br>Spinal System (K132421), DPS T-PAL Spacer System (K162358) and<br>Medtronic Anatomic PEEK PTC Cervical Fusion System (K133653). |
| Device Description | This submission is to update language in the Indications for Use, and<br>update language in the package insert in reference to MR testing.<br><br>There is no change with this submission from the primary predicate.<br><br>This submission does not change or add any new instruments.<br><br>The Tyber Medical PT Interbody System, manufactured from PEEK-<br>Optima® LT1, with a plasma-sprayed integrated commercially pure<br>titanium. The system consists of implants available in various foot<br>prints, heights, and lordotic configurations with an open architecture<br>to accept packing of bone graft materials. The exterior of the device<br>has "teeth" or other generally sharp engagement members on the<br>superior and inferior surfaces to help prevent the device from<br>migrating once it is surgically positioned. |
| Intended Use/<br>Indications for use | Cervical System Indications:<br>The Tyber Medical PT Interbody Spacer System is indicated for use as<br>an intervertebral body fusion device in skeletally mature patients<br>with degenerative disc disease (defined as discogenic back pain with<br>degeneration of the disc confirmed by patient history and<br>radiographic studies) at one level of the cervical spine with<br>accompanying radicular symptoms. Patients should have six weeks ofto facilitate fusion in the cervical spine (C2-T1) and are placed via an<br>anterior approach using autogenous bone and/or allogenic bone graft<br>comprised of cancellous and/or corticocancellous bone graft. When<br>used as an interbody fusion device, supplemental fixation must be<br>used.<br><br>Lumbar System Indications:<br>The Tyber Medical PT Interbody Spacer System is indicated for use as<br>intervertebral body fusion devices in skeletally mature patients with<br>degenerative disc disease (defined as discogenic back pain with<br>degeneration of the disc confirmed by patient history and<br>radiographic studies) at one or two contiguous levels of the lumbar<br>spine (L2-S1). DDD patients may have up to Grade 1 spondylolisthesis<br>or retrolisthesis at the involved levels. These patients may also have<br>had a previous non-fusion spinal surgery at the involved spinal<br>level(s). Additionally, the Tyber Medical PT Interbody System can be<br>used in patients diagnosed with spinal deformities as an adjunct to<br>fusion. Patients should have six weeks of non-operative treatment<br>prior to surgery. These implants are used to facilitate fusion in the<br>lumbar spine and are placed via either a posterior, transforaminal,<br>lateral or anterior approach using autograft and/or allogenic bone<br>graft comprised of cancellous and/or corticocancellous bone graft.<br>When used as interbody fusion devices these implants are intended<br>for use with supplemental fixation systems cleared for use in the<br>thoracolumbar spine. |
| Performance Data<br>(Non-Clinical) | No new mechanical testing was performed, because there is no change to<br>the device.<br>MR testing was performed per ASTM F2052-15, ASTM F2119-07, ASTM<br>F2213-06, ASTM F2503-13 & ASTM F2182-11a. |
| Performance Data<br>(Clinical) | Clinical data and conclusions were not needed for this device. |
| Statement of<br>Technological<br>Comparison | The Tyber Medical PT Interbody System and its predicate devices have the<br>same indications for use. There is no change in design, materials, or<br>mechanical properties from the primary predicate.<br>The Tyber Medical PT Interbody System has similar design, materials, and<br>mechanical properties to the additional predicate devices. |
| Conclusion | The Tyber Medical PT Interbody System is substantially equivalent to the<br>predicate device because it has similar indications for use, and the design,<br>materials, application, manufacturing process, and anatomic mechanical<br>properties are all unchanged.<br>The Tyber Medical PT Interbody System is substantially equivalent to the<br>additional predicate devices because the materials, indications, product<br>code, application, range of sizes, and designs are similar. |

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K180590
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