510(k) · Cleared
ClearedGso ACP1 Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gold Standard Orthopedics, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jul 25, 2011 as substantially equivalent to K021461 (Medtronic Sofamor Danek, 2002) and 5 other predicates after a 108-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 25, 2011
- Review
- 108 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K002592 (2000). 9 ancestors in all, the oldest K974885 (1998). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002592 | Interpore Cross Anterior Cervical Plate System | Interpore Cross Intl. | 2000 | — |
| −1 | K040844 | Life Spine Neo Anterior Cervical Plate System | Life Spine, LLC | 2004 | — |
| 0 (this device) | K110990 | Gso ACP1 Anterior Cervical Plate System | Gold Standard Orthopedics, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 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? (6)
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 |
|---|---|---|---|
| * | K021461 | Atlantis Vision Anterior Cervical Plate SystemSummary page 2…including: . Medtronic Sofamor Danek Atlantis Vision Anterior Cervical Plate, 510(k) Number K021461, cleared July 22, 2002 . Synthes Cervical Spine Locking Plate (CSLP), 510(k) Number… | 2002 |
| * | K030866 | Synthes Anterior CSLP SystemSummary page 2…510(k) Number K021461, cleared July 22, 2002 . Synthes Cervical Spine Locking Plate (CSLP), 510(k) Number K030866 cleared for distribution on April 18, 2003 * Blackstone Medical Anterior Cervical Plate, 510(k) Nu… | 2003 |
| * | K974885 | Blackstone Medical Inc. Anterior Cervical Plate SystemSummary page 2…0866 cleared for distribution on April 18, 2003 * Blackstone Medical Anterior Cervical Plate, 510(k) Number K974885 cleared for distribution on June 17, 1998 * Life Spine, LLC, NEOTM Cervical Plating System, 510(k)… | 1998 |
| * | K040844 | Life Spine Neo Anterior Cervical Plate SystemSummary page 2…5 cleared for distribution on June 17, 1998 * Life Spine, LLC, NEOTM Cervical Plating System, 510(k) Number K040844, cleared for distribution on July 23, 2004 * Spinal USA, Slimplicity Anterior Cervical Plate Syste… | 2004 |
| * | K060025 | Slimplicity Anterior Cervical Plate SystemSummary page 2…d for distribution on July 23, 2004 * Spinal USA, Slimplicity Anterior Cervical Plate System, 510(k) Number K060025, cleared for distribution on April 18, 2006 * EBI, L.P., VueLock Anterior Cervical Plate System, 5… | 2006 |
| * | K023133 | Modification to Ebi Vuelock Anterior Cervical Plate SystemSummary page 2…eared for distribution on April 18, 2006 * EBI, L.P., VueLock Anterior Cervical Plate System, 510(k) Number K023 133, cleared for distribution on October 18, 2002 9. Device The ACPI Anterior Cervical Plate System consists of… | 2002 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 13 other devices also cite its predicate K021461.
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 GSO ACPI Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis…
Read the full statement (117 words)
The GSO ACPI Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, deformity (defined as kyphosis, lordlosis, or scoliosis), pseudlarthroses, and/or failed previous fusions.
WARNING: This device system is intended for anterior cervical interbody fusions only. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110990: Gso ACP1 Anterior Cervical 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/K110990
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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