NEXTGEN ALTIUS OCT SYSTEM— 510(k) K122378

Clearance details

Applicant

Biomet Spine (Aka Ebi, LLC)

Product code

Code KWP

Device class

Class 2

Regulation

21 CFR 888.3050

Advisory panel

Orthopedic

Date received

2012-08-06

Decision date

2012-09-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Parsippany, NJ, US

• K143278 — LnK Posterior Cervical Fixation System2015-07-29
• K150753 — OASYS System2015-06-09
• K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System2015-06-04
• K142867 — Reliance Posterior Cervical-Thoracic System2015-04-29
• K150254 — Streamline OCT Occipito-Cervico-Thoracic System2015-04-28

• K133518 — MAXAN ANTERIOR CERVICAL PLATE SYSTEM2014-11-05
• K140710 — BIOMET GRAFT DELIVERY SYRINGES2014-09-04
• K132373 — BIOMET ACCESS SYSTEM2014-03-27
• K133746 — POLARIS SPINAL SYSTEM2014-03-12
• K131615 — POLARIS SPINAL SYSTEM2013-09-04

Death

7

Injury

1,539

Malfunction

1,519

Total

3,065

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-2759-2015 — Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.Class II·Terminated·Biomet Spine, LLC·20150722

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122378.