IMPIX 3D Print Cages— 510(k) K163595

Clearance details

Applicant

Medicrea International SA

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2016-12-21

Decision date

2017-11-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rillieux-La-Pape, FR

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24
• K213281 — PASS LP Spinal System, CD Horizon Spinal System2022-01-05
• K210470 — C-CURVE Interbody Fusion Device2021-09-03
• K200316 — UNiD IB3D ALIF2020-10-30
• K191134 — IB3D ALIF2019-10-30

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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-2452-2023 — IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbarClass II·Ongoing·Medicrea International·20230712
• Z-1156-2020 — Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010Class II·Terminated·Medicrea International·20191002

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163595.