# K232561: Ripley Spinal Screw System by SAGICO

- Pathway: 510(k) (Traditional)
- Applicant: Sagico VA USA, LLC
- Decided: Oct 23, 2023 after 60 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K950697 (1995). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180220: SAGICO OSI Spinal System by Osimplant, Spinal Analytics & Geometrical Implant Co, LLC (2018) Summary page 4.
- K113666: Xia 3 Spinal System, Stryker Spine (2012) Summary page 4.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 4.
- K091445: CD Horizon Spinal System, Medtronic Sofamor Danek (2010) Summary page 4.
- K994121: Small Stature Uss, Synthes (Usa) (2000) Summary page 4.
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments, Materialise NV (2011) Summary page 4.

## Indications for use
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: - Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); - Spondylolisthesis; - Trauma (i.e. fracture or dislocation); - Spinal stenosis; - Curvatures (i.e. scoliosis, kyphosis, and/or lordosis); - Tumor; - Pseudoarthrosis; and - Failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Source page: https://510kreport.com/device/K232561
Methodology: https://510kreport.com/methodology