Erisma-LP Spinal Fixation System— 510(k) K153326

Clearance details

Applicant

Clariance, Sas

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2015-11-19

Decision date

2016-03-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Beaurains, FR

• K261217 — AnyPlus II Spinal Fixation System2026-10-02
• K263062 — NOVIX Pedicle Screw System2026-10-01
• K262712 — Duet Spinal Fixation System2026-09-30
• K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
• K252139 — Kentrospine Viktr-MIS® Pedicle screw system2026-09-27

• K202032 — Idys LLIF 3DTi2021-04-01
• K202956 — Erisma LP Navigated Instruments2021-02-26
• K200920 — Idys ALIF ZP 3DTi2020-05-29
• K192168 — Idys ALIF ZP 3DTi2019-11-04
• K191263 — Idys ALIF TiVac2019-06-06

Death

27

Injury

5,033

Malfunction

4,140

Total

9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1986-2019 — Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening WrenchClass III·Terminated·Clariance Inc·20190701

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153326.