# K171434: ROCCIA® MultiLIF

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Dec 21, 2017 after 220 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 17 generations back to K841189 (1984). 165 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153419: NuVasive CoRoent Thoracolumbar System, Nu Vasive, Incorporated (2016) Summary page 5.

## Most influential descendants
- K180963: Roccia Alif, Roccia Tlif (2018), 3 descendants of its own
- K212075: ShurFit Lumbar Interbody System (2021), 1 descendant of its own
- K221172: FOCUS Interbody System (2022), 0 descendants of its own
- K190680: Favo S-Tlif (2019), 0 descendants of its own

## Indications for use
The ROCCIA® MultiLIF is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The ROCCIA® MultiLIF implants are intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The ROCCIA® MultiLIF implants are intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ROCCIA® MultiLIF implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K171434
Methodology: https://510kreport.com/methodology