510(k) · Cleared
ClearedGolden Gate Anterior Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 4, 2011 as substantially equivalent to K971248 (Acromed Corp., 1997) and 3 other predicates after a 266-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Feb 4, 2011
- Review
- 266 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K983583 (1998). 13 ancestors in all, the oldest K873826 (1988). No later device cites it as a predicate yet.
- Root · 4 generations backK983583 Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 3 generations backK994347 Centaur Spinal SystemHowmedica Osteonics Corp. · 2000
- 2 generations backK002824 Macs Modular Anterior Construct SystemAesculap, Inc. · 2001
- 1 generation backK032059 Modification to Macs Modular Anterior Construct SystemAesculap, Inc. · 2003
- This deviceK101353 Golden Gate Anterior Plate SystemUlrich GmbH & Co. KG · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983583 | Depuy Acromed Moss and Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −3 | K994347 | Centaur Spinal System | Howmedica Osteonics Corp. | 2000 | — |
| −2 | K002824 | Macs Modular Anterior Construct System | Aesculap, Inc. | 2001 | — |
| −1 | K032059 | Modification to Macs Modular Anterior Construct System | Aesculap, Inc. | 2003 | — |
| 0 (this device) | K101353 | Golden Gate Anterior Plate System | Ulrich GmbH & Co. KG | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971248 | Kaneda SR Anterior Spinal SystemSummary page 2…2 OF Page 106 Predicate Devices: Kaneda SIR (K971248) MACS TL (K002824 and K032059) Z-Plate (K922543) Technological The golden gateTM… | 1997 |
| * | K002824 | Macs Modular Anterior Construct SystemSummary page 2…OF Page 106 Predicate Devices: Kaneda SIR (K971248) MACS TL (K002824 and K032059) Z-Plate (K922543) Technological The golden gateTM System possesses the same technologica… | 2001 |
| * | K032059 | Modification to Macs Modular Anterior Construct SystemSummary page 2…OF Page 106 Predicate Devices: Kaneda SIR (K971248) MACS TL (K002824 and K032059) Z-Plate (K922543) Technological The golden gateTM System possesses the same technological Characteri… | 2003 |
| * | K922543 | Z-Plate Anterior Fixation SystemSummary page 2…Page 106 Predicate Devices: Kaneda SIR (K971248) MACS TL (K002824 and K032059) Z-Plate (K922543) Technological The golden gateTM System possesses the same technological Characteristics: characteristics as the predi… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 13 ancestors has a recall.
- 6 other devices also cite its predicate K971248.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The golden gateTM anterior plate system is intended to provide stabilization during the development of a spinal fusion. The golden gate TM System is indicated for use in the anterior/anterolateral thoracolumbar spine (T1-L5) for the treatment of:
* DDID (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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101353: Golden Gate Anterior Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101353
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026