ENNOVATE®— 510(k) K180433

Clearance details

Applicant

Aesculap Implant Systems, LLC

Product code

Code NKB

Device class

Class 2

Regulation

21 CFR 888.3070

Advisory panel

Orthopedic

Date received

2018-02-20

Decision date

2018-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Center Valley, PA, US

• K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-09-04
• K253943 — Tiger 2 System2026-07-24
• K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)2026-07-24
• K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System2026-07-14
• K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD2026-07-01

• K213871 — Ennovate Cervical Spinal and Occiput System2022-07-01
• K210963 — ENNOVATE Spinal System2021-07-19
• K162134 — ENNOVATE Spinal System2016-12-14
• K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments2016-07-08
• K153396 — Aesculap OrthoPilot Next Generation2016-05-16

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-1638-2022 — Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014Class II·Ongoing·Aesculap Implant Systems LLC·20220715

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180433.