# K213935: PISCES-SA Standalone ALIF Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Osseus Fusion Systems
- Decided: May 6, 2022 after 141 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- 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). 1,055 ancestors in all.
12 later devices descend from it; 4 cite it directly.
2 of 1,068 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191391: HEDRON Lumbar Spacers, Globus Medical, Inc. (2019) Summary page 6.
- K181347: Aries® Lumbar Interbodies, Osseus Fusion Systems, LLC (2018) Summary page 6.
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System, Ldr Spine USA (2016) Summary page 6.
- K203742: IdentiTi ALIF Standalone Interbody System, Alphatec Spine, Inc. (2021) Summary page 6.
- K192121: Black Diamond Pedicle Screw System, Osseus Fusion Systems (2019) Summary page 6.

## Most influential descendants
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own
- K240326: Solar™ Lumbar Interbody Fusion System (2024), 4 descendants of its own
- K223413: Pisces™-SA STANDALONE ALIF Interbody System (2023), 3 descendants of its own
- K241077: DeGen Medical Patient Specific Implant (PSI) System (2024), 2 descendants of its own
- K240126: ProAM ALIF System (2024), 2 descendants of its own

## Indications for use
PISCES™-SA ALIF Spacers (Standalone Use, With Integrated Fixation) The PISCES™-SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. * PISCES™-SA Used With Screws: When used with three (3) screws, interbody devices with a lordotic angle < 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels. Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels. » PISCES™-SA Used With Anchors When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation. PISCES™ ALIF Spacers (Without Integrated Fixation) PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L.1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

Source page: https://510kreport.com/device/K213935
Methodology: https://510kreport.com/methodology