TRANS1 INTERBODY FUSION SYSTEM

K120991 · Trans1 Incorporated · MAX · Aug 23, 2012 · Orthopedic

Device Facts

• Record ID: K120991
• Device Name: TRANS1 INTERBODY FUSION SYSTEM
• Applicant: Trans1 Incorporated
• Product Code: MAX · Orthopedic
• Decision Date: Aug 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Device Story

Radiolucent PEEK interbody fusion implant; various heights/footprints to accommodate patient anatomy. Used in spinal fusion procedures; implanted via anterior, transforaminal, or posterior approaches. Requires autogenous bone graft and supplemental spinal fixation system. Used in clinical settings by surgeons to provide structural stability in lumbar spine. Benefits patients by facilitating fusion in DDD cases.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077-11 and ASTM F2267-04, including static/dynamic compression, static compression shear, static torsion, subsidence, and expulsion. Results met or exceeded requirements.

Technological Characteristics

Radiolucent PEEK interbody fusion implant. Dimensions vary by patient anatomy. Mechanical testing per ASTM F2077-11 (compression, shear, torsion) and ASTM F2267-04 (subsidence).

Indications for Use

Indicated for spinal fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. Includes patients with up to Grade 1 spondylolisthesis or retrolisthesis who failed six months of 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

• Life Spine Plateau Spacer System (K111569)

Submission Summary (Full Text)

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K12 0991

AUG 2 3 2012

Trant

Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

July 2012

#### Submitter: Contact Person:

TranS1. Inc. 301 Government Center Drive Wilmington, NC 28403

# Cheryl L Waqoner Director of Regulatory 910-332-1703 (phone), 910-233-1701 (fax)

Proprietary Name: TranS1® Interbody Fusion System Classification: 888.3080: Intervertebral Fusion Device (MAX) Predicate Device: Life Spine Plateau Spacer System: K111569

## Indications and Intended use:

The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

## Device Description

The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.

## Technological Characteristics and Substantial Equivalence

Documentation was provided to demonstrate that the TranS1® Interbody Fusion System is substantially equivalent to the Predicate Life Spine Plateau Spacer System (K111569). The Subject device is substantially equivalent to the Predicate devices in intended use, level of attachment, materials, labeling, sterilization, and technological characteristic. These devices

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have the same intended use and indications and rely on the same fundamental scientific technology; therefore the Subject device is substantially equivalent to the Predicate devices.

#### Summary of Testing

Mechanical testing for the TranS1 Interbody Fusion System was performed per ASTM standards and included:

| Test | Standard |
|--------------------------|---------------|
| Static Compression | ASTM F2077-11 |
| Static Compression Shear | ASTM F2077-11 |
| Static Torsion | ASTM F2077-11 |
| Subsidence | ASTM F2267-04 |
| Expulsion | N/A |
| Dynamic Compression | ASTM F2077-11 |

All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. The results demonstrated that the subject TranS1 Interbody Fusion System presents no new worst-case for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.

#### Conclusion

Based on the indications for use, technological characteristics, and comparison to predicate device, the subject TranS1 Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

Trans1 Incorporated % Ms. Cheryl L Wagoner Director of Regulatory 301 Government Center Drive Wilmington, North Carolina 28403

AUG 2 3 2012

Re: K120991

Trade/Device Name: TranS1® Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 23, 2012 Received: July 23, 2012

Dear Ms. Wagoner:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2- Ms. Cheryl L Wagoner

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

For
N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Statement of Indications for Use

510(k) Number: _K120991_

Device Name: TranS1® Interbody Fusion System

Indications for Use:

The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and These DDD patients may also have up to Grade 1 spondylolisthesis or radiographic studies. retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Col-S
(Division Sign Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

长120991 510(k) Number_

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