(217 days)
Not Found
No
The document describes a physical implant (fusion cage) and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for intervertebral body fusion procedures to treat degenerative disc disease, aiming to restore disc height and stabilize the spine.
No
This device is described as an intervertebral body fusion cage system intended for spinal fixation and fusion procedures, not for diagnosing conditions.
No
The device description clearly states it is a "Lumbar Intervertebral body Fusion Cage System" consisting of physical implants made of PEEK and titanium. This is a hardware device, not software.
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: The VENUS Lumbar Intervertebral body Fusion Cage System is an implantable device made of PEEK and titanium. It is surgically placed in the spine to aid in fusion.
- Intended Use: The intended use is for intervertebral body fusion procedures in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolistesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The VENUS Lumbar Intervertebral body Fusion Cage devices intended for use as an aid in spinal fixation. The VENUS Lumbar Intervertebral body Fusion Cage System 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 PEEK-OPTIMA LTI body with the titanium marker pins made of Titanium alloy (Ti-6Al-4V ELI).
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)
The VENUS Lumbar Intervertebral body Fusion Cage devices were tested according to the ASTM F 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 F 2267.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 100516, K083661, K090816, K093704, K053508, K062083, K072253, K081888, K101720, K092162
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.
0
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| 1. | Submitter: | L&K BIOMED Co., Ltd.
#1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong,
Geumcheon-gu, Seoul 153-803 Republic of Korea
Phone. 82-2-2624-1471
FAX. 82-2-2624-1477 |
| ---- | ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person:
FAX .82-2-2624-147 Hee Kyeong Joo
2. Device Identification
| Trade Name | VENUS Lumbar Intervertebral body Fusion Cage System |
|---|---|
| Common Name | Intervertebral Fusion Device |
| Classification Name | Intervertebral body fusion device (888.3080) |
| Product Code | MAX |
3. Predicate or legally marketed devices which are substantially equivalent
- GS Medical: K 100516 .
- . Stryker Spine : K083661,K090816,K093704
- Synthes : K053508, K062083, K072253 .
- Spine Art : K081888, K101720
- ◆ Solco Biomedical : K092162
4. Description of the Device
The VENUS Lumbar Intervertebral body Fusion Cage devices intended for use as an aid in spinal fixation. The VENUS Lumbar Intervertebral body Fusion Cage System 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 PEEK-OPTIMA® LTI body with the titanium marker pins made of Titanium alloy (Ti-6Al-4V ELI).
Traditional 510(K)
Image /page/0/Picture/21 description: The image shows the text 'Ps 1 of 2' written in black ink on a white background. The text appears to be handwritten. The 'Ps' is slightly smaller than the other characters.
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5. Intended use
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolistesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
6. Performance Data
The VENUS Lumbar Intervertebral body Fusion Cage devices were tested according to the ASTM F 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 F 2267.
- Comparison of the technology characteristics of the device to predicate and legally 7. marketed devices
There are no significant differences between the VENUS Lumbar Intervertebral body Fusion Cage System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
8. Conclusion
The VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the devices referenced above and therefore safe and effective for its intended use.
Traditional 510(K)
Pg 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 4 2011
L & K Biomed Co., LTD. % Ms. Hee Kyeong Joo Room 1104, Ace High-End Tower 3, 371-50 Gasan-Dong, Geumcheon-gu, Seoul 153-803, Republic of Korea
Re: K110783
Trade/Device Name: VENUS Lumbar Intervertebral Body Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 07, 2011 Received: October 11, 2011
Dear Ms. Joo:
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
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Page 2 - Ms. Hee Kyeong Joo
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/Resourcesfor You/Industry/default.htm.
Sincerely vours;
Sincerely yours,
Eriul Keith
For 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 : K110783
Device Name : VENUS Lumbar Intervertebral body Fusion Cage System
Indications for Use :
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spóndylolistesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Prescription Use _ V _ V (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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| Traditional 510(K) | Page 16/44 |
|---|---|
| -------------------- | ------------ |
| Pg 1 of 1 | 510(k) Number | K110783 |
|---|---|---|
| ----------- | --------------- | --------- |