# K181899: Roccia® Plif

- Pathway: 510(k) (Traditional)
- Applicant: Silony Medical GmbH
- Decided: Dec 13, 2018 after 150 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: 15 generations back to K841189 (1984). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133650: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space, Aesculap Implant Systems, Inc. (2008) Summary page 4.
- K122317: Tetris II, Signus Medizintechnik GmbH (2012) Summary page 4.
- K122639: Synthes Syncage Evolution Spacer, Synthes (USA) Products, LLC (2013) Summary page 4.

## Indications for use
The ROCCIA PLIF System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the ROCCIA PLIF System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open posterior approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K181899
Methodology: https://510kreport.com/methodology