# K162367: Erisma® LP MIS

- Pathway: 510(k) (Traditional)
- Applicant: Clariance, Sas
- Decided: Oct 27, 2016 after 65 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: 9 generations back to K950697 (1995). 64 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 67 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.
- K122845: ES2 Spinal System Model 48280XXXX, Stryker Spine (2012) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Erisma® LP MIS components are intended for percutaneous, posterior, non-cervical pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications: • Degenerative disc disease (Define as back pain of discogenic origin 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/K162367
Methodology: https://510kreport.com/methodology