Z1 Hip System— 510(k) K233476

Name: FDA 510(k) clearance K233476
Creator: U.S. Food and Drug Administration
Published: 2024-02-08

Substantially Equivalent

Orchard Medical Development

FDA 510(k) clearance K233476 for Z1 Hip System, Substantially Equivalent on 2024-02-08. Applicant: Orchard Medical Development. Device class: 2.

Clearance details

Applicant: Orchard Medical Development
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2023-10-25
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rosemont, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

view all

K253948 — Momentum Acetabular Cup System2026-09-02
K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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 →

Recalls naming K233476

K-number listed on FDA's recall record

Z-1329-2025 — Z1 Femoral Hip System, Product Number 611777612Class II·Ongoing·Zimmer, Inc.·20250212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233476.

Data sourced from openFDA. This site is unofficial and independent of the FDA.