Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray— 510(k) K172849

Clearance details

Applicant

Intellijoint Surgical, Inc.

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2017-09-20

Decision date

2017-11-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Waterloo, CA

• K262506 — Remex Spine Surgery Navigation - Universal Instruments2026-08-20
• K261410 — Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))2026-07-30
• K261205 — SPINEART Navigation Instrument System2026-07-29
• K261024 — TMINI Miniature Robotic System2026-07-24
• K262121 — Ion-L Navigated Instruments2026-07-24

• K211876 — Intellijoint VIEW2021-11-12
• K191507 — Intellijoint® Navigation System2019-10-01
• K171525 — Intellijoint HIP Generation 2B System2017-10-30
• K162364 — Intellijoint HIP Generation 2A System2017-03-02
• K151364 — Intellijoint HIP(tm) System2015-12-28

Death

11

Injury

2,799

Malfunction

11,105

Other

1

Total

13,916

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-2228-2019 — Workstation, G2, Configured (P/N 000-0241)Class II·Terminated·Intellijoint Surgical, Inc.·20190628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172849.