(319 days)
Not Found
No
The 510(k) summary describes a physical implant (lumbar fusion cage) made of PEEK and tantalum. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven functionality. The performance studies are based on mechanical testing of the physical device.
Yes
The device is described as an implantable cage intended for use in spinal fusion surgery to treat degenerative disc disease, which is a medical condition. Its purpose is to facilitate bone fusion and stabilize the spine, directly addressing a health issue.
No
This device is an implantable lumbar fusion cage used to treat degenerative disc disease, not to diagnose it. Its purpose is to mechanically stabilize the spine and promote fusion.
No
The device description clearly states it is an implant made of PEEK and Tantulum, which are hardware materials. It also describes physical characteristics like height, lordotic configurations, and open architecture for bone graft.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical implant (a lumbar fusion cage) used to treat degenerative disc disease in the spine. It is physically implanted into the patient's body.
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples, nor does it provide diagnostic information. Its function is structural support and fusion promotion within the spine.
Therefore, based on the provided information, the AnyPlus® PEEK Lumbar Fusion Cage device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AnyPlus® PEEK Lumbar Fusion Cage device is intended 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). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
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 OPTIMA LTI) (Manufacturer - INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). This submission includes the addition of sizes to the model PLIF devices, a revision of the shapes of the ALIF, PLIF and TLIF model and the addition of the TPLIF model based on the PLIF design to accommodate surgeons using a Transforaminal Posterior Lateral Interbody Fusion (TPLIF) surgical approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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)
Non-Clinical Testing:
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.
All performance test results were equivalent to or higher than a legally marketed predicate device.
Clinical Testing:
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K111354GS Medical AnyPlus® PEEK Lumbar Cage
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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510(k) SUMMARY
Manufacturer:
GS Medical Co., Ltd. 90, Osongsaengmyeong 4-ro Osong-eup Cheongwon-gun Chungcheongbuk-do 363-951 Korea
Date:
April 18, 2014
Submitted by:
GS Medical Co., Ltd
Company Contact
J. W. Park +82 43 2377393 +82 43 2377403(FAX) jaewoo@gsmedi.cafe24.com
US Agent Information Official Correspondent Orgenix LLC Mr. Donald W. Guthner 111 Hill Road Douglassville, PA 19518 +1-646-460-2984 +1-484-363-5879 (FAX) dg@orgenix.com
Intervertebral Body Fusion Device
Classification Name:
Common/Usual Name:
Performance standards:
Proprietary Name:
AnyPlus® PEEK ALIF PEEK Lumbar Fusion Cage AnyPlus® PEEK PLIF PEEK Lumbar Fusion Cage AnyPlus® PEEK TLIF PEEK Lumbar Fusion Cage AnyPlus® PEEK TPLIF PEEK Lumbar Fusion Cage
Intervertebral Body Fusion Device, IBF Device
The GS Medical AnyPlus PEEK Lumbar Cage was non-clinically tested according to the ASTM 2077-03 and ASTM F2267-04 performance standards.
Classification no .:
21 CFR 888.3080 MAX - Intervertebral body fusion device Class II
Substantial Equivalence:
Substantial equivalence for the GS Medical AnyPlus PEEK Lumbar Cage is based on its similarities in indications for use, design features, operational principles and material composition when compared to the
APR 1 8 2014
1
predicate devices cleared under the following submissions:
- K111354GS Medical AnyPlus® PEEK Lumbar Cage .
Predicate Devices:
The subject device is substantially equivalent to similar previously cleared devices.
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 OPTIMA LTI) (Manufacturer - INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). This submission includes the addition of sizes to the model PLIF devices, a revision of the shapes of the ALIF, PLIF and TLIF model and the addition of the TPLIF model based on the PLIF design to accommodate surgeons using a Transforaminal Posterior Lateral Interbody Fusion (TPLIF) surgical approach.
The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous Intended Use: 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). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.
Summary of Technological The GS Medical AnyPlus PEEK Lumbar Cage devices are designed for Characteristics 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 The intended use, technological characteristics, mode of Tantulum 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 Non-Clinical Testing 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.
All performance test results were equivalent to or higher than a legally marketed predicate device.
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Clinical Testing
Conclusion
No clinical testing was performed.
The GS Medical AnyPlus® ALIF PEEK Cage, AnyPlus® PLIF PEEK Cage, AnyPlus® T-PLIF PEEK Cage and AnyPlus® TLIF PEEK Cage have the same intended use and similar indications, principles of operation, and technological characteristics as the GS Medical AnyPlus® ALIF PEEK Cage, AnyPlus® PLIF PEEK Cage and AnyPlus® TLIF PEEK Cage. The minor differences in the designs do not raise any new questions of safety or effectiveness. Performance data demonstrates that the AnyPlus® ALIF PEEK Cage, AnyPlus® PLIF PEEK Cage, AnyPlus® T-PLIF PEEK Cage and AnyPlus® TLIF PEEK Cage are as safe and effective as the AnyPlus® ALIF PEEK Cage, AnyPlus® PLIF PEEK Cage and AnyPlus® TLIF PEEK Cage].
Thus, the AnyPlus® ALIF PEEK Cage, AnyPlus® PLIF PEEK Cage, AnyPlus® T-PLIF PEEK Cage and AnyPlus® TLIF PEEK Cage are substantially equivalent to its predicate devices
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2014
GS Medical Company, Limited % Orgenix, LLC Mr. Donald W. Guthner Regulatory Consultant 111 Hill Road Douglassville, Pennsylvania 19518
Re: K131612
Trade/Device Name: AnyPlus® ALIF, PLIF, TLIF and TPLIF PEEK Lumbar Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 19, 2014 Received: March 20, 2014
Dear Mr. Guthner:
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 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. Donald W. Guthner
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safetv/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.
Ronald P. Jean -S 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 Statement
K131612 510(k) Number (if known):
Device Name: AnyPlus® ALIF PEEK Cage, AnyPlus® PLIF PEEK Cage, AnyPlus® T-PLIF PEEK Cage and AnyPlus® TLIF PEEK Cage
Indications for Use:
AnyPlus® PEEK Lumbar Fusion Cage device is intended 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). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.
Prescription Use X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dimitriev, PhD Division of Orthopedic Devices