# K180963: Roccia Alif, Roccia Tlif

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Jul 11, 2018 after 90 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: 18 generations back to K841189 (1984). 201 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171434: ROCCIA® MultiLIF, Silony Medical GmbH (2017) Summary page 4.
- K141217: Acculif TL and PL Cage, Stryker Corporation (2014) Summary page 4.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 4.
- K151214: ALIF Interfixated System, Nu Vasive, Incorporated (2015) Summary page 4.
- K153720: ENZA Zero-Profile Anterior Interbody Fusion, Camber Spine Technologies (2016) Summary page 4.

## Most influential descendants
- 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 TLIF and ROCCIA ALIF Cage 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 device is to be used in patients who have had at least six months of non-operative treatment. The ROCCIA TLIF Cage 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 TLIF and ROCCIA ALIF Cage 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 TLIF Cage implants can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

Source page: https://510kreport.com/device/K180963
Methodology: https://510kreport.com/methodology