# K241863: Erisma® Lp Spinal Fixation System; Erisma® LP MIS

- Pathway: 510(k) (Special)
- Applicant: Clariance
- Decided: Jul 24, 2024 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: 26 generations back to K853033 (1985). 609 ancestors in all.
No later device cites it as a predicate yet.
2 of 610 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240872: Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System, Clariance (2024) Summary page 4.
- K162367: Erisma® LP MIS, Clariance, Sas (2016) Summary page 4.

## 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 (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) 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/K241863
Methodology: https://510kreport.com/methodology