(283 days)
P960025, K090887
Not Found
No
The 510(k) summary describes a physical implant (lumbar cage) and its mechanical testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets.
Yes
The device is described as an implant used for treating degenerative disc disease, which involves a health condition and aims to restore function or alleviate symptoms.
No
The device is an implantable lumbar cage used for spinal fusion, not for diagnosing medical conditions.
No
The device description clearly states the device is an implant made of PEEK and Titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health.
- This device is an implantable medical device. It is a lumbar cage designed to be surgically placed in the spine to aid in fusion.
- The description focuses on the physical characteristics and mechanical testing of the implant. It does not mention any analysis of biological samples.
- The intended use is for treating degenerative disc disease by providing structural support and facilitating bone fusion. This is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, the AnyPlus PEEK Lumbar Cage is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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 nonoperative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Product codes
OVD
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal levels from L2-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P960025, K090887
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
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.(b)
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.
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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 +82-2-2082-777 +82-2-2082-7778 (FAX) US Agent Information Orgenix LLC Mr. Donald W. Guthner I I I Hill Road Douglassville, PA 19518 +1-646-460-2984 +1-484-363-5879 (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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing service, science, and security. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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
3
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 (800) 638-2041 or (301) 796-7100 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_