(266 days)
No
The summary describes a mechanical spinal plate system and does not mention any AI or ML components or functionalities.
Yes
The device is described as an anterior plate system intended to provide stabilization during the development of a spinal fusion for various spinal conditions, which directly indicates a therapeutic purpose.
No
This device is a surgical stabilization and fixation system used to promote spinal fusion, not to diagnose a condition. Its indications for use describe the conditions it treats, not conditions it diagnoses.
No
The device description explicitly states that the system includes physical components such as plates, screws, and connectors, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "stabilization during the development of a spinal fusion" and "surgical stabilization and fixation of the thoracolumbar spine." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details "plates, screws and connectors" used for "surgical stabilization and fixation." These are physical components implanted during surgery.
- 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. This device does not perform any such tests on biological samples.
The information provided describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The golden gate™ anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate™ System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: DDD (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), Spondylolisthesis, Spondylolysis, Fracture (including dislocation or subluxation), Spinal stenosis, Deformities (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Revision of previous surgery.
Product codes
KWQ
Device Description
The golden gate™ anterior plate system is used for the surgical stabilization and fixation of the thoracolumbar spine to provide a suitable environment for fusion to occur. The fixation components of the system include plates, screws and connectors (hex nuts and inlays). These are available in a variety of sizes and lengths to accommodate differing patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior/anterolateral thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
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)
Static compression bending and torsion, and dynamic compression bending of the worst case golden gate™ construct was performed following ASTM F1717. The mechanical test results demonstrate that the golden gate™ System performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kaneda SR (K971248), MACS TL (K002824 and K032059), Z-Plate (K922543)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
上101353
FEB - 4 2011
Image /page/0/Picture/2 description: The image shows the logo for Ulrich Medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" partially overlapping a black square. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.
510(k) Summary
Date: Sponsor: 21 December 2010 ulrich GmbH & Co. KG
Buchbrunnenweg 12 89081 Ulm Germany Phone: +49 (0) 731-9654-1304 Fax: +49 (0) 731-9654-2802
Contact Person:
Hans Stover ulrich medical USA, Inc. 612 Trade Center Blvd. Chesterfield, MO 63005 (636) 519-0268 Office (636) 519-0271 Fax
Proposed Trade
golden gate™ System
Device Classification Class II
Spinal intervertebral body fixation orthosis Classification Name:
Anterior thoracolumbar plate system Common Name:
Regulation:
Name:
Code:
Device Product
KWQ
888.3060
The golden gate™ anterior plate system is used for the surgical Device Description: stabilization and fixation of the thoracolumbar spine to provide a suitable environment for fusion to occur. The fixation components of the system include plates, screws and connectors (hex nuts and inlays). These are available in a variety of sizes and lengths to accommodate differing patient anatomy.
The golden gate™ anterior plate system is intended to provide Intended Use: stabilization during the development of a spinal fusion. The golden gate™ system is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of: DDD (back pain of discogenic origin with degeneration of the disc as confirmed by Spondylolisthesis, patient history and radiographic studies), Spondylolysis, Fracture (including dislocation or subluxation), Spinal stenosis, Deformities (i.e., scoliosis, kyphosis, lordosis), Tumor, Pseudarthrosis, Revision of previous surgery.
Materials:
The golden gate™ system components are manufactured from titanium alloy (Ti-6Al-4V) as described by ISO 5832-3 / ASTM F136.
Page 1 of 2
1
| Predicate Devices: | Kaneda SR (K971248)
MACS TL (K002824 and K032059)
Z-Plate (K922543) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The golden gate™ System possesses the same technological
characteristics as the predicate devices. These include basic design
(rod/plate-based screw system), material (titanium or titanium alloy),
sizes (rod/plate lengths and screw diameters and lengths are within
the range(s) offered by the predicate systems) and intended use (as
described above). The fundamental scientific technology of the
golden gate™ System is the same as previously cleared devices. |
| Performance Data: | Static compression bending and torsion, and dynamic compression
bending of the worst case golden gate™ construct was performed
following ASTM F1717. The mechanical test results demonstrate that
the golden gate™ System performs as well as or better than the
predicate devices. |
| Conclusion: | The golden gate™ System is substantially equivalent to the devices
referenced above and is therefore as safe and as effective for its
intended use. |
11 : 1 : 1 : 1
.
u
. .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB = 4 2011
ulrich GmbH & Co.. KG % ulrich medical USA. Inc. Mr. Hans Stover President and CEO 612 Trade Center Boulevard Chesterfield. Missouri 63005
Re: K101353
Trade/Device Name: golden gate™ System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 22, 2010 Received: December 23, 2010
Dear Mr. Stover:
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 intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Fedral Food, Dr to 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 links and warranties. We remind you; however, that device labeling must be truth tol and not muchading.
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 devices on 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.
and the country of the county of the county of
3
Page 2 - Mr. Hans Stover
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 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/CDRHQffices/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/ReportalProblem/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 .-
At B. Rt
for.
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 Statement
510(k) Number:_K|01353
Device Name: golden gate™ system
Indications for Use:
The golden gate™ anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate™ System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of:
- . DDD (back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
- Spondylolisthesis, .
- Spondylolysis, .
- Fracture (including dislocation or subluxation), .
- Spinal stenosis, .
- Deformity (i.e., scoliosis, kyphosis, lordosis), ●
- Tumor, .
- Pseudarthrosis, .
- Revision of previous surgery .
| Prescription Use | X |
|---|---|
| (21 CFR 801 Subpart D) |
AND/OR
| Over-the-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Krol 353 510(k) Number_