(101 days)
Not Found
No
The summary describes a physical implant (a fusion cage) and its intended use, materials, and predicate devices. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as "VENUS Lumbar Intervertebral body Fusion Cage System" and its "Intended Use / Indications for Use" section states it is "indicated for intervertebral body fusion procedures" to treat "degenerative disc disease (DDD)". This clearly indicates its role in treating a medical condition, making it a therapeutic device.
No
The VENUS Lumbar Intervertebral body Fusion Cage System is a medical implant intended for spinal fusion procedures, providing support and facilitating bone growth rather than diagnosing a condition.
No
The device description explicitly states it consists of implants made of PEEK and titanium, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The VENUS Lumbar Intervertebral body Fusion Cage System is an implantable device designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is a physical device used within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by fusing vertebral bodies. This is a therapeutic intervention, not a diagnostic test.
Therefore, the VENUS Lumbar Intervertebral body Fusion Cage System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
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 spondylolisthesis 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 System is intend to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental 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-6AI-4V ELI). The purpose of this submission is to add a new Lumbar Interbody device: VENUS DLIF Cages and to expand the size of the devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, 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 proposed line extension for the VENUS Lumbar Intervertebral body Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (K110783).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110783, K100516, K083661, K090816, K093704, K092162, K081888, K101720, K100175, K112405, K113528
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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APR 1 9 2012
K120063
page 1 of 2
L&K BIOMED
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 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hee Kyeong Joo
Phone. 82-2-2624-1475
FAX. 82-2-2624-1477
E-mail: hkjoo83@gmail.com |
| Date Prepared | January 6, 2012 |
2. Device Identification
| Trade Name | VENUS Lumbar Intervertebral body Fusion Cage System |
|---|---|
| Common/Usual Name | Intervertebral Fusion Device |
| Regulation Name | Intervertebral body fusion device (21 CFR 888.3080) |
| Regulatory Class | Class II |
| Product Code | MAX |
3. Description of the Device
The VENUS Lumbar Intervertebral body Fusion Cage System is intend to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental 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-6AI-4V ELI). The purpose of this submission is to add a new Lumbar Interbody device: VENUS DLIF Cages and to expand the size of the devices.
4. 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 spondylolisthesis 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.
1
K120063
page 2 of 2
L&K BIOMED
5. Non-clinical Testing
The proposed line extension for the VENUS Lumbar Intervertebral body Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (K110783).
6. Summary of technology characteristics
The VENUS Lumbar Intervertebral body Fusion Cage System shares technological characteristics similar to the predicate devices. These characteristics include similar design, the same materials and the same intended use.
7. Predicate or legally marketed devices which are substantially equivalent
The design feature and indications for the subject VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the following predicates:
- L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System(K110783) .
- GS Medical: Any Plus PEEK Cage (K100516) .
- STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) .
- Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) .
- Spine Art : JULIET OL , DYNAMIK Intervertebral body fusion device . (K081888, K101720)
- Medtronic Sofamor Danek: CLYDESDALE Spinal System . (K100175,K112405,K113528)
8. Conclusion
The VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
APR 1 9 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room –WO66-G609 Silver Spring, MD 20993-0002
L&K BIOMED Company, Limited % Hee Kyeong Joo Manager #1104, Ace High-end Tower 3 cha, 371-50, Gasan-Dong Geumcheon-gu, Seoul 153-803 Republic of Korea
Re: K120063
Trade/Device Name: VENUS Lumbar Intervertebral body Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: March 28, 2012 Received: March 30, 2012
Dear Hee Kyeong 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 r read be active 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 or uny I catalog and the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 – 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 (OS) 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 yours,
Erine Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number : K/20063
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 spondylolisthesis 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 (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)
| Special 510(K) | Page 13/65 |
|---|---|
| ---------------- | ------------ |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K120063 |
|---|---|
| --------------- | --------- |