510(k) · Cleared
ClearedPisces-SC Standalone Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osseus Fusions Systems, LLC · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Aug 21, 2026 as substantially equivalent to K233594 (Genesys Spine, 2023) and 3 other predicates after a 77-day review. Its family tree reaches back 29 generations to 1984. 4 of the 1,136 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 21, 2026
- Review
- 77 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 29 generations to K841189 (1984). 1,135 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 4 of the 1,136 devices in this family, counting this one, have a Class I recall.
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations between
- 3 generations backK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- 2 generations backK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- 1 generation backK253876 HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc. · 2025
- This deviceK261882 Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
Show all 29 generations
- Root · 29 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 28 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 27 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 26 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 25 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 24 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 23 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 22 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 21 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 20 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 19 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 18 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 17 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 16 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 15 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 14 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 13 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 12 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 11 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 10 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 9 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 8 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 7 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 6 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 5 generations backK203714 NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent…Nu Vasive, Incorporated · 2021
- 4 generations backK222276 CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine · 2022
- 3 generations backK223731 NuVasive Modulus-C Interbody SystemNuvasive, Inc. · 2023
- 2 generations backK231735 NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small…Nu Vasive, Incorporated · 2023
- 1 generation backK253876 HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc. · 2025
- This deviceK261882 Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −28 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −27 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −26 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −25 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −24 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −23 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −22 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −21 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −20 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −19 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −18 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −17 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −16 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −15 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −14 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −13 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −12 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −11 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −10 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −9 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −8 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −6 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −5 | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar… | Nu Vasive, Incorporated | 2021 | — |
| −4 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty | Depuy Spine | 2022 | — |
| −3 | K223731 | NuVasive Modulus-C Interbody System | Nuvasive, Inc. | 2023 | — |
| −2 | K231735 | NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured… | Nu Vasive, Incorporated | 2023 | — |
| −1 | K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) | Globus Medical, Inc. | 2025 | — |
| 0 (this device) | K261882 | Pisces-SC Standalone Cervical Interbody System | Osseus Fusions Systems, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 3 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 18 | 0 |
| 1996 | 20 | 0 |
| 1997 | 17 | 0 |
| 1998 | 23 | 0 |
| 1999 | 25 | 0 |
| 2000 | 33 | 0 |
| 2001 | 43 | 0 |
| 2002 | 38 | 0 |
| 2003 | 42 | 0 |
| 2004 | 75 | 0 |
| 2005 | 66 | 0 |
| 2006 | 46 | 0 |
| 2007 | 41 | 0 |
| 2008 | 86 | 1 |
| 2009 | 62 | 0 |
| 2010 | 49 | 1 |
| 2011 | 72 | 0 |
| 2012 | 48 | 0 |
| 2013 | 50 | 0 |
| 2014 | 52 | 0 |
| 2015 | 49 | 1 |
| 2016 | 38 | 1 |
| 2017 | 30 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 9 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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.
4 devices in this family have a Class I recall. 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemSummary page 5…Class II Reviewing Panel Orthopedic Product Code OVE Primary Predicate (K233594) Genesys Spine 3DP AIS-C II Cervical Interbody System Additional Predic… | 2023 |
| * | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemSummary page 5…(K233594) Genesys Spine 3DP AIS-C II Cervical Interbody System Additional Predicates • (K200543) NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System… | 2020 |
| * | K223869 | ChoiceSpine Blackhawk Ti Cervical Spacer SystemSummary page 5…3) NEXXT MATRIXX® Stand Alone Cervical-Turn Lock (-TL) System • (K223869) ChoiceSpine Blackhawk Ti Cervical Spacer System… | 2023 |
| * | K253876 | HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Summary page 5…• (K223869) ChoiceSpine Blackhawk Ti Cervical Spacer System • (K253876) Globus Hedron C-MIS Device Description: The Pisces-SC Standalone Cervical Interbody System is a standalone interbody fusion de… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 42 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 126 of the 1,135 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K233594.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Pisces-SC Standalone Cervical Interbody System is a standalone anterior cervical interbody fusion device indicated for use at one or two contiguous levels in the cervical spine (C2-T1) in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1 (DDD is defined as discogenic pain with degeneration of…
Read the full statement (200 words)
The Pisces-SC Standalone Cervical Interbody System is a standalone anterior cervical interbody fusion device indicated for use at one or two contiguous levels in the cervical spine (C2-T1) in skeletally mature patients who have had six weeks of non-operative treatment for the following: degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1 (DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), cervical spondylotic myelopathy, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, kyphosis, or lordosis), pseudoarthrosis, and failed previous fusion. The Pisces-SC Standalone Cervical Interbody System is to be used with autogenous and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone graft to facilitate fusion. The Pisces-SC Standalone Cervical Interbody System is intended to be used with or without two screws and/or anchors which accompany the interbodies.
When used with two screws, the devices are intended for standalone use (requiring no supplemental fixation) at one or two contiguous levels.
When used with one or more anchors or without integrated fixation (screws / anchors), these devices require additional supplemental fixation (i.e. anterior cervical plate or posterior cervical screws).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261882: Pisces-SC Standalone Cervical Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261882
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026