STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM

K073109 · Surgicraft , Ltd. · OVD · Jun 4, 2008 · Orthopedic

Device Facts

• Record ID: K073109
• Device Name: STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
• Applicant: Surgicraft , Ltd.
• Product Code: OVD · Orthopedic
• Decision Date: Jun 4, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIFTM TT system may be used with bone grafting material (autograft only).

Device Story

Radiolucent intervertebral body fusion (IBF) cage; includes unicortical cancellous bone screws. Designed for stand-alone use without supplementary fixation. Features central cavity for autogenous bone graft packing. Cross-section profile matches vertebral body endplate. Available in varying widths, heights, and hole positions to accommodate patient anatomy. Implanted by surgeons via laparoscopic or open anterior approach. Provides structural support to facilitate spinal fusion in DDD patients. Benefits include stabilization of spinal segment and promotion of bone fusion.

Clinical Evidence

No clinical data. Bench testing only, including static and dynamic mechanical testing (ASTM F 2077-03) and subsidence testing (ASTM F 2267-04).

Technological Characteristics

Radiolucent intervertebral body fusion cage with unicortical cancellous bone screws. Stand-alone system. Mechanical testing performed per ASTM F 2077-03 (static/dynamic) and ASTM F 2267-04 (subsidence).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 Spondylolisthesis or retrolisthesis. Requires six months of prior non-operative treatment. Suitable for patients with previous non-fusion spinal surgery at the treated level.

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

• Intrepid™ Spinal System Device (K080083)
• STALIFTM TT Vertebral Body Replacement Device (K051027, K041617)
• STALIFT™ C Intervertebral Body Fusion Device (K072415)
• LT-Cage Lumbar Tapered Fusion Device (P970015, S022)

Submission Summary (Full Text)

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K073109

Image /page/0/Picture/1 description: The image shows the word "SURGICRAFT" in bold, black letters. Above the word, there are three curved lines stacked on top of each other. The lines are also black and appear to be a stylized design element.

JUN - 4 2008

## 510 (k) Summary

| A | 510(k) Owner | Surgicraft Limited<br>16 The Oaks<br>Clews Road<br>Redditch, Worchester<br>England B98 7ST |
|---|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Donald W. Guthner<br>Orgenix, LLC<br>111 Hill Road<br>Douglassville, PA 19518<br>[phone]<br>[phone] (FAX)<br>[e-mail] |
| | Preparation Date | May 15, 2008 |
| B | Trade Name | STALIFT™ TT Intervertebral Body Fusion System |
| | Common Name | Intervertebral Body Fusion Device |
| | Classification Name | 21 CFR 888.3080<br>MAX - Intervertebral body fusion device<br>Class II |
| C | Predicate Device(s) | The subject device is substantially equivalent to similar<br>previously cleared devices. Substantial equivalence for the<br>Surgicraft STALIFTM TT is based on its similarities in<br>indications for use, design features, operational principles<br>and material composition when compared to the predicate<br>devices cleared under the following submissions:<br>• K080083 - Intrepid™ Spinal System Device,<br>Medtronic Sofamor Danek, USA<br>• K051027, K041617 - STALIFTM TT Vertebral Body<br>Replacement Device, Surgicraft Limited<br>• K072415 - STALIFT™ C Intervertebral Body Fusion<br>Device, Surgicraft Limited<br>• P970015, S022 - LT-Cage Lumbar Tapered Fusion<br>Device, Medtronic Sofamor Danek, USA |

Surgicraft Limited / 16 The Oaks / Clews Road / Redditch / Worcestershire / UK / BBB 7ST

Tel: [phone] / Fax: [phone] / Customer Service Fax: [phone] / B-mail: [e-mail].k

## www.surgicraft.co.uk

Reightered Citilia 16 This Osloss Purch Redulets Woroestarstare (1K Bail TST Frightfer 39264)

App. 1-16

:

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- The Surgicraft STALIF"M TT is a radiolucent intervertebral D Device Description body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.
- The STALIFTM TT Intervertebral Body Fusion System is E Intended Use indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved DDD is defined as discogenic back pain with levels. degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach..

The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIFTM TT system may be used with bone grafting material (autograft only).

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.

Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

- F Technological Characteristics
App. 1 - 17

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| G | Non-Clinical Testing | As recommended by the Guidance Document, the STALIFTM<br>TT was tested as follows:<br>• Mechanical Testing<br>o ASTM F 2077-03 – Static and Dynamic Tests<br>o ASTM F 2267-04 – Subsidence Test |
|---|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| H | Clinical Testing | Not applicable to this device |
| I | Conclusions | Based on the 510(k) Summary and the information provided<br>herein, we conclude that the Surgicraft STALIFTMTT is<br>substantially equivalent to the existing legally marketed<br>devices under the Federal Food, Drug and Cosmetic Act. |
| J | Additional Information | No additional information |

:

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Surgicraft Limited % Orgenix, LLC Mr. Donald W. Guthner 111 Hill Road Douglassville, PA 19518

SEP 12 2011

Re: K073109

Trade/Device Name: Stalif™ TT Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 15, 2008 Received: May 20, 2008

Dear Mr. Guthner:

This letter corrects our substantially equivalent letter of June 4, 2008.

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 (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.

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

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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 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 vours.

Sincerely yours,

Mark A. Mulkersen

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

510(k) Number (if known):

Device Name: STALIFTM TT Intervertebral Body Fusion System

Indications for Use:

The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.

The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

The STALIFTM TT system may be used with bone grafting material (autograft only).

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.R. dgh for mxm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K073109