510(k) · Cleared
ClearedGPS Cervical Spacers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G Surgical, LLC · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 23, 2021 as substantially equivalent to K142456 (G Surgical, LLC, 2015) after a 29-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Apr 23, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P950002 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 3 generations backK072226 Impix SpacerMedicrea Technologies · 2007
- 2 generations backK083798 Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 2010 · Recalled
- 1 generation backK142456 GPS SpacersG Surgical, LLC · 2015
- This deviceK210890 GPS Cervical SpacersG Surgical, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −3 | K072226 | Impix Spacer | Medicrea Technologies | 2007 | — |
| −2 | K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf | Medicrea Technologies | 2010 | 2 |
| −1 | K142456 | GPS Spacers | G Surgical, LLC | 2015 | — |
| 0 (this device) | K210890 | GPS Cervical Spacers | G Surgical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K142456 | GPS SpacersSummary page 4…GmbH). Integral marker pins are manufactured from tantalum according to ASTM F560. Primary Predicate: GPS T M Spacers (G Surgical LLC - K142456) Performance Data: No new mechanical testing was performed for the GPSTM Cervical Spacers because… | 2015 |
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 25 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The GPSTM Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210890: GPS Cervical Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210890
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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