TRANSCORP ACIF SYSTEM

K092794 · Transcorp, Inc. · ODP · Sep 13, 2010 · Orthopedic

Device Facts

• Record ID: K092794
• Device Name: TRANSCORP ACIF SYSTEM
• Applicant: Transcorp, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Sep 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Device Story

Transcorp ACIF System consists of hollow PEEK implants for cervical intervertebral body fusion. Implants are placed via anterior approach at C3-C7 levels to facilitate fusion in patients with degenerative disc disease. Device is hollow to contain autogenous bone graft. Used in conjunction with supplemental fixation. Intended for surgical use by physicians. Benefits include stabilization of the spinal segment to promote fusion.

Clinical Evidence

No clinical testing was performed. Evidence is based on bench testing including static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077-03, subsidence testing per ASTM F2267-04, and wear debris analysis per ASTM F1877-05.

Technological Characteristics

Implant manufactured from implant-grade PEEK (ASTM F2026-08). Hollow design for autogenous bone graft. Mechanical testing performed per ASTM F2077-03 (compression, shear, torsion) and ASTM F2267-04 (subsidence). Wear debris analysis per ASTM F1877-05. Non-sterile.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one level (C3-C7). Requires neck pain of discogenic origin confirmed by history/radiography and failure of at least six weeks of non-operative treatment. Must be used with supplemental fixation and autogenous bone graft.

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

• Alphatec Novel Spinal Spacer System (K081730)
• BAK/C Vista Cervical Interbody Fusion Device (P980048)

Submission Summary (Full Text)

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Ko92794

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# 510(k) Summary Pursuant to 21 CFR 807.92c

SEP 1 8 2010

#### Submitted By:

Andrew Rodenhouse Transcorp, Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-877-4177 Fax: [phone]

Date:

September 10, 2010

Device Information:

| Trade Name: | Transcorp ACIF System |
|-----------------|--------------------------------------------------------|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | 21 CFR Section 888.3080, Product Code ODP,<br>Class II |

## Predicate Devices:

K081730 Alphatec Novel Spinal Spacer System P980048 BAK/C Vista Cervical Interbody Fusion Device

#### Device Description:

The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.

#### Intended Use:

The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with

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the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

### Performance Data:

Performance testing was performed on the Transcorp ACIF System. Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion testing per ASTM F2077-03, and subsidence testing per ASTM F2267-04. A wear testing analysis was performed to determine particulate generation during dynamic axial compression and dynamic torsion testing. The wear debris was collected and analyzed per ASTM F1877-05. No clinical testing was performed.

# Substantial Equivalence:

The Transcorp ACIF System is equivalent to the predicate devices in design, function, intended use, and indications for use. The results of non-clinical performance testing and analysis have demonstrated that the Transcorp ACIF System is substantially equivalent to the predicate devices.

Pay 2.f2

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.

#### Public Health Service

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

Transcorp, Inc. % Mr. Andrew Rodenhouse 1000 100th Street, SW - Suite F Byron Center, Michigan 49315

Re: K092794

SEP 1 3 2010

Trade/Device Name: Transcorp ACIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 02, 2010 Received: September 02, 2010

Dear Mr. Rodenhouse:

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

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Page 2 - Mr. Andrew Rodenhouse

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 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 vours.

Barbara Buettner

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

Enclosure

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# Indications for Use Statement

510(k) Number: Ko92794

Device Name: Transcorp ACIF System i;

SEP 1 3 2010

K692794

Indications for Use:

The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

Prescription Use X Over-the-counter use or (per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

KO92794 510(k) Number_