# K261882: Pisces-SC Standalone Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusions Systems, LLC
- Decided: Aug 21, 2026 after 77 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 29 generations back to K841189 (1984). 1,135 ancestors in all.
No later device cites it as a predicate yet.
4 of 1,136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System, Genesys Spine (2023) Summary page 5.
- K200543: NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System, Nexxt Spine, LLC (2020) Summary page 5.
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System, Choice Spine, LLC (2023) Summary page 5.
- K253876: HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer), Globus Medical, Inc. (2025) Summary page 5.

## Indications for use
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).

Source page: https://510kreport.com/device/K261882
Methodology: https://510kreport.com/methodology