TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF

K130573 · Tyber Medical, LLC · ODP · Sep 30, 2013 · Orthopedic

Device Facts

• Record ID: K130573
• Device Name: TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
• Applicant: Tyber Medical, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Sep 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tyber Medical Interbody Systems are 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). Patients should have six months of non-operative 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 autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine. The Tyber Medical Cervical Interbody Systems System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative 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 implans are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

Device Story

Tyber Medical Interbody System consists of PEEK-Optima intervertebral spacers; available in various footprints, heights, and lordotic configurations; open architecture for autograft packing; superior/inferior surfaces feature teeth/engagement members to prevent migration. Optional plasma-sprayed commercially pure titanium coating on superior/inferior surfaces. Used by surgeons in spinal fusion procedures; implanted via anterior, posterior, transforaminal, or lateral approaches. Device facilitates spinal fusion by maintaining disc space height and providing a scaffold for bone growth. Benefits include stabilization of spinal segments and potential reduction of discogenic pain. No software or electronic components.

Clinical Evidence

Bench testing only. Mechanical testing included static and dynamic compression, torsion, and compression-shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing. Coating characterization included static shear (ASTM F1044), static tension (ASTM F1147), and abrasion (ASTM F1978). No clinical data was required or provided.

Technological Characteristics

Materials: PEEK-Optima, optional plasma-sprayed commercially pure titanium coating. Standards: ASTM F2077 (mechanical), ASTM F2267 (subsidence), ASTM F1044 (shear), ASTM F1147 (tension), ASTM F1978 (abrasion). Form factor: Intervertebral spacers with teeth/engagement members. Non-electronic, non-software device.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain confirmed by history/radiography). Lumbar: 1-2 contiguous levels (L2-S1) after 6 months non-operative treatment. Cervical: 1 level (C2-T1) with radicular symptoms after 6 weeks non-operative treatment. Requires autogenous bone and supplemental fixation.

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

• X-SPINE; Calix - K112036
• SPINAL ELEMENTS; Lucent and Lucent Magnum - K110632
• DEPUY SPINE; Bengal, Concorde, Cougar, Devex, and Leopard - K081917
• AESCULAP; ASpace, CESpace, Prospace, T-Space - K071983
• SYNTHES; Opal and Oracle Spacer - K072791
• SYNTHES; T-Pal - K100089
• CHOICE SPINE; STEATH PEEK Cervical Fusion Device- K120570

Submission Summary (Full Text)

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TYBER MEDICAL Interbody System

510(k) Premarket Notification

K130573 Page 1 of 2

# 510(k) Summary

## TYBER MEDICAL Interbody System

| Submitter by: | Tyber Medical LLC<br>89 Headquarters Plaza North, #1464<br>Morristown, New Jersey 07960 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jeff Tyber<br>CEO and President<br>Phone: [phone] Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | July 22, 2013 |
| Common Names | Intervertebral Body Fusion Device |
| Trade Name | Tyber Medical Interbody System - ACIF, ALIF, PLIF, TLIF, and DLIF |
| Classification Name<br>and Number | Intervertebral body fusion device (21 CFR 888.3080) |
| Product Code | ODP and MAX |
| Predicate Devices | 1. X-SPINE; Calix - K112036<br>2. SPINAL ELEMENTS; Lucent and Lucent Magnum - K110632<br>3. DEPUY SPINE; Bengal, Concorde, Cougar, Devex, and Leopard - K081917<br>4. AESCULAP; ASpace, CESpace, Prospace, T-Space - K071983<br>5. SYNTHES; Opal and Oracle Spacer - K072791<br>6. SYNTHES; T-Pal - K100089<br>7. CHOICE SPINE; STEATH PEEK Cervical Fusion Device- K120570 |
| Device Description | The Tyber Medical Interbody System, manufactured from PEEK-Optima®.<br>consist of implants available in various foot prints, heights and lordlotic<br>configurations with an open architecture to accept packing of autograft<br>materials. The exterior of the device has "teeth" or other generally sharp<br>engagement members on the superior and inferior surfaces to help prevent the<br>device from migrating once it is surgically positioned. The device comes in a<br>PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on<br>the superior and inferior surfaces. |
| Intended Use/<br>Indications for use | The Tyber Medical Interbody Systems are indicated for use as intervertebral<br>body fusion devices in skeletally mature patients with degenerative disc<br>disease (defined as discogenic back pain with degeneration of the disc<br>confirmed by patient history and radiographic studies) at one or two<br>contiguous levels of the lumbar spine (L2-S1). Patients should have six months<br>of non-operative treatment prior to surgery. These implants are used to<br>facilitate fusion in the lumbar spine and are placed via either a posterior,<br>transforaminal, lateral or anterior approach using autogenous bone. When used<br>as interbody fusion devices these implants are intended for use with<br>supplemental fixation systems cleared for use in the thoracolumbar spine. |

SEP 3 0 2013

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TYBER MEDICAL Interbody System

510(k) Premarket Notification

K130573 Page 2 of 2

#### Cervical System Indications

The Tyber Medical Cervical Interbody Systems System is indicated for use as an intervertebral body fusion device 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 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 facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used. Performance Data Non-clinical mechanical testing was performed consisting of Static and (Non-Clinical and/or Dynamic Compression, Torsion, Compression-Shear per ASTM F2077. Clinical) Additionally, Subsidence Testing per ASTM F2267 and Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978. All data indicates the device is substantial equivalence to the predicate systems Clinical data and conclusions were not needed for this device. Statement of The Tyber Medical Interbody System and its predicate devices have the same Technological indications for use; same design; are made of similar materials, same Comparison application, and have the same anatomic mechanical properties. Conclusion The Tyber Medical Interbody System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation.

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Image /page/2/Picture/0 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 an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 30, 2013

Tyber Medical LLC Mr. Jeff Tyber CEO and President 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960

Rc: K130573

Trade/Device Name: Tyber Medical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 10, 2013 Received: August 12. 2013

Dear Mr. Tyber:

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 warrenties. We remind you, however, that device labeling must be truthful and not misfeading.

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

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#### Page 2 - Mr. Jeff Tyber

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.

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" (21CFR 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,

Mark NijMelkerson -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

K130573 510(k) Number (if known):

Device Name:

Tyber Medical Interbody System

#### Indications for Use:

The Tyber Medical Interbody Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative dise 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). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via cither a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

#### Cervical System Indications

The Tyber Medical Cervical Interbody Systems System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative 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 symploms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implans are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

#### Prescription Use X AND/OR Over-the-counter

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODI)

Anton E. Dmitriev, PhD Division of Orthopedic Devices