IMPIX LUMBAR INTERBODY DEVICE— 510(k) K100544

Clearance details

Applicant

Medicrea Technologies

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2010-02-25

Decision date

2010-07-22

Decision

Substantially Equivalent

Clearance type

Special

Location

Round Rock, TX, US

• 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

• K102406 — PASS ANTERIOR SPINAL SYSTEM2011-08-23
• K083798 — IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF2010-05-19
• K100297 — PASS LP SPINAL SYSTEM2010-03-04
• K083810 — PASS LP SPINAL SYSTEM2009-07-31
• K083308 — PASS LP SPINAL SYSTEM2008-12-10

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-2455-2023 — IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbarClass II·Ongoing·Medicrea International·20230712

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100544.