ANYPLUS PEEK CAGES

K100516 · GS Medical Co., Ltd. · OVD · Dec 3, 2010 · Orthopedic

Device Facts

• Record ID: K100516
• Device Name: ANYPLUS PEEK CAGES
• Applicant: GS Medical Co., Ltd.
• Product Code: OVD · Orthopedic
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Device Story

AnyPlus PEEK Lumbar Cages are intervertebral body fusion implants designed for spinal stabilization. Implants feature open architecture for autogenous bone graft packing and are available in various heights and lordotic configurations. Used by surgeons in clinical settings to restore intervertebral disc space height following discectomy. Device provides structural support to facilitate fusion at L2-S1 levels. Benefit includes stabilization of spinal segments in patients with discogenic back pain.

Clinical Evidence

Bench testing only. Device performance evaluated via static and dynamic axial compression, compression-shear, torsion, expulsion, and subsidence testing per ASTM 2077 and ASTM 2267 standards.

Technological Characteristics

Materials: Polyether-ether-ketone (PEEK) body with Ti-6Al-4V (Titanium alloy) x-ray markers. Design: Open architecture for bone graft packing, various heights/lordotic configurations. Standards: ASTM 2077-03, ASTM F2267-04. Mechanical testing: Static/dynamic axial compression, compression-shear, torsion, expulsion, and subsidence.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment. Used with 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

• Brantigen Interbody Fusion Cage (P960025)
• ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF Intervertebral Body Fusion Cage (K090887)

Submission Summary (Full Text)

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DEC - 3 2010 510(k) Summary GS Medical Co. Ltd. Manufacturer: 12F Kolon Digital Tower Aston, 505-14 Gasan-Dong Geumcheon-gu, Seoul, Korea Date: September 3, 2010 Submitted by: GS Medical Co. Ltd Company Contact Dong Young Kim [phone] [phone] (FAX) US Agent Information Orgenix LLC Mr. Donald W. Guthner I I I Hill Road Douglassville, PA 19518 [phone] [phone] (FAX) Intervertebral Body Fusion Device Classification Name: Common/Usual Name: Intervertebral Body Fusion Device, IBF Device Proprietary Name: AnyPlus ALIF PEEK Lumbar Cage AnyPlus PLIF PEEK Lumbar Cage AnyPlus TLIF PEEK Lumbar Cage The GS Medical AnyPlus PEEK Lumbar Cage was non-clinically Performance standards: tested according to the ASTM 2077-03 and ASTM F2267-04 performance standards. 21 CFR 888.3080 Classification no .: MAX – Intervertebral body fusion device Class II Substantial equivalence for the GS Medical AnyPlus PEEK Substantial Equivalence: Lumbar Cage is based on its similarities in indications for use, design features, operational principles and material composition to the predicate devices cleared under the when compared

following submissions:

- P960025 Brantigen Interbody Fusion Cage, DePuy Spine .
- K090887 ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL .

ALIF Intervertebral Body Fusion Cage, SpineCraft, LLC

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Predicate Devices:

Device Description:

Intended Use:

Summary of Technological Characteristics

Non-Clinical Testing

Conclusion

The subject device is substantially equivalent to similar previously cleared devices.

The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V).

The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of nonoperative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The GS Medical AnyPlus PEEK Lumbar Cage devices are designed for restoring the height of the intervertebral space after resection of the disc. The AnyPlus PEEK Lumbar Cage devices consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). The intended use, technological characteristics, mode of action and materials of construction are the same as those of the referenced predicate devices

The GS Medical AnyPlus PEEK Lumbar Cage devices were tested according to the ASTM 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM 2267.

The information discussed above demonstrates that the GS Medical PEEK Lumbar Cage device is effective and performs as well as or better than the predicate devices.

> . . : . :

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

GS Medical Co., Ltd. % Orgenix, LLC. Mr. Donald W. Guthner 111 Hill Road Douglassville, Pennsylvania 19518

SEP 1 2 2011

Re: K100516

Trade/Device Name: AnyPlus PEEK Lumbar Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: October 21, 2010 Received: October 22, 2010

Dear Mr. Guthner:

This letter corrects our substantially equivalent letter of December 3, 2010.

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 yours,

Mark A. Milkerson

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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DEC - 3 2010

## Indications for Use

KI00516 510(k) Number (if known):

Device Name: AnyPlus PEEK Lumbar Cages

Indications for Use:

The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

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)

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

510(k) Number_