# K153326: Erisma-LP Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Clariance, Sas
- Decided: Mar 8, 2016 after 110 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K944736 (1995). 18 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120469: Erisma-LP, Clariance (2012) Summary page 4.

## Most influential descendants
- K170163: Erisma® LP Spinal Fixation System (2017), 2 descendants of its own
- K162367: Erisma® LP MIS (2016), 2 descendants of its own
- 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
- K191810: Curiteva Pedicle Screw System (2019), 0 descendants of its own

## Recalls of this device
- Jul 1, 2019 · Class III · Z-1986-2019: Potential for the polyaxial screw to become disassembled during implant.

## 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 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/K153326
Methodology: https://510kreport.com/methodology