510(k) · Cleared
ClearedGPS 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 10, 2015 as substantially equivalent to K083798 (Medicrea Technologies, 2010) after a 220-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Apr 10, 2015
- Review
- 220 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P950002 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK072226 Impix SpacerMedicrea Technologies · 2007
- 1 generation backK083798 Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfMedicrea Technologies · 2010 · Recalled
- This deviceK142456 GPS SpacersG Surgical, LLC · 2015
- Descendant · cites it directly · 0 of its ownK210890 GPS Cervical SpacersG Surgical, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K210890GPS Cervical SpacersG Surgical, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K072226 | Impix Spacer | Medicrea Technologies | 2007 | — |
| −1 | K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf | Medicrea Technologies | 2010 | 2 |
| 0 (this device) | K142456 | GPS Spacers | G Surgical, LLC | 2015 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K083798 | Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar IbfSummary page 5…from tantalum according to ASTM F560. Predicate Devices: Primary: IMPIX Interbody Devices (Medicrea™ Technologies – K083798) Reference: MC+ (LDR Spine USA – K091088) BAK/C (CenterPu… | 2010 |
| † | K091088 | LDR Spine Cervical Interbody Fusion System | 2009 |
| † | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | 2001 |
| † | K090064 | Eminent Spine Interbody Fusion System | 2009 |
| † | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210890 | GPS Cervical Spacers | 2021 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K210890 (G Surgical, LLC, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K083798.
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. 2015, 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?
When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device…
Read the full statement (204 words)
When used as a cervical intervertebral fusion device, the GPS™ Cervical Spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.
When used as a lumbar intervertebral body fusion device, the GPS™ PLIF and TLIF Spacers are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). The device is to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142456: GPS Spacers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142456
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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