PROVIDENCE CERVICAL CAGE

K122801 · Providence Medical Technology, Inc. · ODP · May 24, 2013 · Orthopedic

Device Facts

• Record ID: K122801
• Device Name: PROVIDENCE CERVICAL CAGE
• Applicant: Providence Medical Technology, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: May 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

Device Story

PMT Cervical Cage is an intervertebral fusion device used in cervical spinal fusion surgery to provide mechanical support. The device is a rectangular, fenestrated cage with teeth on superior and inferior surfaces for endplate contact. It is implanted by a surgeon during a procedure requiring autogenous bone graft and supplemental fixation (e.g., anterior plating system). The device facilitates spinal fusion, potentially alleviating discogenic pain associated with degenerative disc disease. It is supplied sterile for single use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including static and dynamic compression and torsion testing (ASTM F2077-11), subsidence testing (ASTM F2267-04), and expulsion testing (ASTM Draft Standard F-04.25.02.02).

Technological Characteristics

Manufactured from Titanium-6AL-4V ELI alloy (ASTM F136). Rectangular box design with fenestrations and surface teeth for endplate fixation. Supplied sterile for single use. No energy source or software components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with radicular symptoms at one level, confirmed by history and radiography, following at least six weeks of failed 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

• Zimmer BAK®/C (P980048B)
• Wenzel VariLift-C (K111123)
• RSB Spine Interplate C (K092070)
• Signur Rabea Ti (K082848)
• Medyssey C7 Anterior Cervical Cage (K121320)

Submission Summary (Full Text)

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# PMT Cervical Cage 510(k) Summary of Safety and Effectiveness

# MAY 2 4 2013

| Submitted By: | Providence Medical Technology, Inc.<br>201 Spear Street, Suite 1310<br>San Francisco, CA. 94105<br>Tel: [phone]<br>Fax: [phone] |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3009394448 |
| Contact Person: | Edward Liou<br>[e-mail]<br>Tel: [phone] |
| Date Summary Prepared: | 17 May 2013 |
| Trade Name: | PMT Cervical Cage |
| Common Name: | Cervical Cage |
| Device Classification Regulation: | 21 CFR §888.3080 - Class II |
| Device Product Code & Panel: | ODP: Intervertebral Fusion Device With Bone Graft, Cervical<br>87, Orthopedics |
| Predicate Device(s): | Zimmer BAK®/C (P980048B)<br>Wenzel VariLift-C (K111123)<br>RSB Spine Interplate C (K092070)<br>Signur Rabea Ti (K082848)<br>Medyssey C7 Anterior Cervical Cage (K121320) |

## Device Information

## A. Intended Use

PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

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#### B. Device Description

The PMT Cervical Cage is an intervertebral fusion device intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and has the following design features:

- Devices are single use and supplied sterile. .
- . Rectangular box shape with fenestrations (graft windows).
- Superior and inferior surfaces feature teeth that provide bony contact with the endplates. .
- Manufactured from Titanium-6AL-4V ELI alloy, conforming to ASTM F136 .
- Available in various footprints and heights. .

#### C. Substantial Equivalence Information

The performance, design, materials used, and intended use of the PMT Cervical Cage are substantially equivalent to previously cleared predicate devices.

#### D. Non-Clinical Test Summary

- Static and Dynamic Compression Testing was conducted per ASTM F2077-11 .
- Static and Dynamic Torsion Testing was conducted per ASTM F2077-11 .
- Subsidence testing was conducted per ASTM F2267-04 .
- Expulsion testing was conducted per ASTM Draft Standard F-04.25.02.02, (ASTM, 2000)

PMT Cervical Cage met or exceeded the performance of predicate devices on these tests. Based on these results, PMT Cervical Cage is substantially equivalent to the predicate devices.

#### E. Conclusions

:

PMT Cervical Cage has the same intended use, design, materials, performance and function of predicate devices. In conjunction with the mechanical testing, PMT Cervical Cage device has been shown to be substantially equivalent to the predicate devices and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 24, 2013

Providence Medical Technology, Incorporated % Mr. Edward Liou Director of Engineering 201 Spear Street, Suite 1310 San Francisco, California 94105

Re: K122801

Trade/Device Name: PMT Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 18, 2013 Received: March 21, 2013

Dear Mr. Liou:

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. Iisting 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 - Mr. Edward Liou

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/6 description: The image shows the name "Erin DKeith" in a stylized font. The name is written in black ink. The letters are bold and have a unique design, with some letters having decorative outlines and patterns.

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): K122801

Device Name: PMT Cervical Cage

Indications for Use:

PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices