Z1 Hip System— 510(k) K260831
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K260831 for Z1 Hip System, Substantially Equivalent on 2026-06-16. Applicant: Zimmer, Inc.. Device class: 2.
Summary
Zimmer's Z1 Hip System is filed under LZO, semi-constrained metal/ceramic/polymer hip prostheses, cemented or non-porous uncemented. The record doesn't list the system's components.
Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Zimmer filed from Warsaw, Indiana. Review took 95 calendar days (March 13 to June 16, 2026).
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code LZO
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view all- K262955 — OsseoFit Stemless Shoulder System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing System
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.