# K203607: MOSS VRS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Biedermann Motech GmbH & Co. KG
- Decided: Aug 20, 2021 after 253 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: 18 generations back to K040583 (2004). 290 ancestors in all.
No later device cites it as a predicate yet.
1 of 291 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181821: MOSS VRS Spinal System, Biedermann Motech GmbH & Co. KG (2018) Summary page 5.
- K131802: Expedium, Viper. Viper 2 Spine System, Depuy Spine, A Johnson & Johnson Company (2013) Summary page 5.
- K132014: GSB Global Spinal Balance System, Nuvasive, Inc. (2013) Summary page 5.
- K160989: NuVasive® Reline® System, Nu Vasive, Incorporated (2016) Summary page 5.
- K162232: MOSS 100 Pedicle Screw System, Biedermann Motech GmbH & Co. KG (2016) Summary page 5.
- K120838: Synthes Matrix System, Synthes Spine (2012) Summary page 5.
- K990745: Modification to Synthes Universal Spinal System, Synthes Spine (1999) Summary page 5.

## Indications for use
The MOSS VRS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: - degenerative disc disease (DDD is 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 - failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MOSS VRS System 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/K203607
Methodology: https://510kreport.com/methodology