# K170163: Erisma® LP Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Clariance, Sas
- Decided: Feb 14, 2017 after 27 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: 14 generations back to K853033 (1985). 84 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153326: Erisma-LP Spinal Fixation System, Clariance, Sas (2016) Summary page 4.
- K120469: Erisma-LP, Clariance (2012) Summary page 4.
- K130877: Expedium Spine System, Medos International SARL (2013) Summary page 4.

## Most influential descendants
- K240872: Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (2024), 1 descendant of its own
- K241863: Erisma® Lp Spinal Fixation System; Erisma® LP MIS (2024), 0 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma® LP Spinal Fixation System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (discogenic pain with degeneration of the disc confirmed by history and radiographic studies); Degenerative spondylolisthesis with objective evidence of neurologic impairment; Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; Fracture Dislocation Scoliosis Kyphosis Spinal tumor Failed previous fusion (pseudarthrosis)

Source page: https://510kreport.com/device/K170163
Methodology: https://510kreport.com/methodology