K101353 · Ulrich GmbH & Co. KG · KWQ · Feb 4, 2011 · Orthopedic
Device Facts
Record ID
K101353
Device Name
GOLDEN GATE ANTERIOR PLATE SYSTEM
Applicant
Ulrich GmbH & Co. KG
Product Code
KWQ · Orthopedic
Decision Date
Feb 4, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3060
Device Class
Class 2
Attributes
Therapeutic
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.
Device Story
The golden gate™ System is an anterior thoracolumbar plate system used for surgical stabilization and fixation of the spine to facilitate fusion. The system consists of titanium alloy plates, screws, and connectors (hex nuts and inlays) available in various sizes to accommodate patient anatomy. It is used by surgeons in an operating room setting. The device provides mechanical stabilization to the spinal column, creating an environment conducive to bone fusion. Clinical benefit is derived from the stabilization of the affected spinal segments, addressing conditions such as fractures, deformities, and degenerative disc disease.
Clinical Evidence
Bench testing only. Static compression, bending, and torsion, and dynamic compression bending were performed according to ASTM F1717. Results demonstrate the system performs as well as or better than the predicate devices.
Technological Characteristics
Components manufactured from titanium alloy (Ti-6Al-4V) per ISO 5832-3 / ASTM F136. Design is a plate-based screw system for spinal fixation. Mechanical testing performed per ASTM F1717.
Indications for Use
Indicated for patients requiring stabilization during spinal fusion in the anterior/anterolateral thoracolumbar spine (T1-L5). Conditions include DDD, spondylolisthesis, spondylolysis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudarthrosis, and revision surgery.
Regulatory Classification
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.
{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)<br>MACS TL (K002824 and K032059)<br>Z-Plate (K922543) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The golden gate™ System possesses the same technological<br>characteristics as the predicate devices. These include basic design<br>(rod/plate-based screw system), material (titanium or titanium alloy),<br>sizes (rod/plate lengths and screw diameters and lengths are within<br>the range(s) offered by the predicate systems) and intended use (as<br>described above). The fundamental scientific technology of the<br>golden gate™ System is the same as previously cleared devices. |
| Performance Data: | Static compression bending and torsion, and dynamic compression<br>bending of the worst case golden gate™ construct was performed<br>following ASTM F1717. The mechanical test results demonstrate that<br>the golden gate™ System performs as well as or better than the<br>predicate devices. |
| Conclusion: | The golden gate™ System is substantially equivalent to the devices<br>referenced above and is therefore as safe and as effective for its<br>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_
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
