Product code LZO: 510(k) clearances and predicates
Product code LZO covers M-Vizion Femoral Revision System Extension. FDA lists 534 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
534 clearances on file under product code LZO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 11 |
| 2023 | 10 |
| 2024 | 11 |
| 2025 | 14 |
| 2026 so far | 8 |
Recent clearances
Newest LZO clearances in the FDA index, with applicant and decision date:
- K260173, M-Vizion Femoral Revision System Extension, applicant Medacta International S.A., decided 2026-09-17. FDA record
- K253948, Momentum Acetabular Cup System, applicant United Orthopedic Corporation, decided 2026-09-02. FDA record
- K261009, MobileLink Acetabular Cup System 40mm ID Inserts (various), applicant Waldemar Link GmbH & Co. KG, decided 2026-07-06. FDA record
- K260831, Z1 Hip System, applicant Zimmer, Inc., decided 2026-06-16. FDA record
- K260182, Avenir® Müller Stem; Avenir Complete Hip System, applicant Zimmer, Inc., decided 2026-04-27. FDA record
- K260037, implantcast Packaging System Update, applicant Implantcast GmbH, decided 2026-03-30. FDA record
- K252401, implaFit® short stems, applicant Implantcast GmbH, decided 2026-03-12. FDA record
- K253171, Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem), applicant Maxx Orthopedics, Inc., decided 2026-01-15. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Momentum Acetabular Cup System, MobileLink Acetabular Cup System 40mm ID Inserts (various). Watch new LZO clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LZO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LZO clearances include M-Vizion Femoral Revision System Extension.
How many 510(k) clearances use product code LZO?
534 at the time this page was generated, from openFDA records.
How do I find a predicate device under LZO?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LZO clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.