# K120469: Erisma-LP

- Pathway: 510(k) (Traditional)
- Applicant: Clariance
- Decided: Aug 13, 2012 after 179 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: 5 generations back to K944736 (1995). 17 ancestors in all.
6 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)
- K052131: Expedium Spine System 5.5MM Commerically Pure Titanium Spinal Rods, Depuy Spine, Inc. (2005) Summary page 1.
- K030840: Modification to Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2003) Summary page 1.
- K001272: Xia Spine System, Howmedica Osteonics Corp. (2000)

## Most influential descendants
- K153326: Erisma-LP Spinal Fixation System (2016), 5 descendants of its own
- 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

## 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 ErismTM Spinal System is indicated as an adjunct to fusion for one or more of the following: * 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-S I) vertebral joint * Fracture, * Dislocation, * Scoliosis, * Kyphosis, * Spinal tumor, * Failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K120469
Methodology: https://510kreport.com/methodology