FDA product code LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LZO is the FDA product code for prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel. FDA has cleared 534 510(k) submissions under LZO, 54 in the last five years, from 108 different applicants. The average 510(k) review took 144 days (median 94); 136 days on average over the last three years. FDA has posted 177 recalls for LZO devices, 33 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3353 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LZO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 16 | 213 |
| 2018 | 18 | 177 |
| 2019 | 28 | 134 |
| 2020 | 18 | 150 |
| 2021 | 12 | 178 |
| 2022 | 11 | 251 |
| 2023 | 10 | 167 |
| 2024 | 11 | 119 |
| 2025 | 14 | 137 |
| 2026 | 8 | 152 |
Compare with all 510(k) review times · Search every LZO clearance
Top LZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medacta International S.A. | 28 | 2026-09-17 |
| Smith & Nephew, Inc. | 24 | 2025-03-28 |
| Zimmer, Inc. | 23 | 2026-06-16 |
| Howmedica Osteonics Corp. | 23 | 2011-02-03 |
| Exactech, Inc. | 21 | 2023-05-19 |
103 more applicants have LZO clearances. See the full list in Caduvo.
Most recent LZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260173 | Medacta International S.A. | M-Vizion Femoral Revision System Extension | 2026-09-17 | 239 |
| K253948 | United Orthopedic Corporation | Momentum Acetabular Cup System | 2026-09-02 | 266 |
| K261009 | Waldemar Link GmbH & Co. KG | MobileLink Acetabular Cup System 40mm ID Inserts (various) | 2026-07-06 | 102 |
| K260831 | Zimmer, Inc. | Z1 Hip System | 2026-06-16 | 95 |
| K260182 | Zimmer, Inc. | Avenir® Müller Stem; Avenir Complete Hip System | 2026-04-27 | 96 |
Recalls for LZO devices
177 product recalls in 69 recall events; 33 initiated in the last five years and 39 still open. Most recent: 2025-09-09.
| Year | Recalls |
|---|---|
| 2017 | 8 |
| 2018 | 5 |
| 2019 | 6 |
| 2020 | 5 |
| 2021 | 8 |
| 2022 | 6 |
| 2023 | 15 |
| 2024 | 5 |
| 2025 | 7 |
Frequently asked questions
What is FDA product code LZO?
LZO is the FDA product code for prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel.
What device class is LZO?
Class II, regulation 21 CFR 888.3353. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZO?
Across 534 cleared submissions the average was 144 days from receipt to decision (median 94).
Which companies have the most LZO clearances?
Medacta International S.A. (28); Smith & Nephew, Inc. (24); Zimmer, Inc. (23); Howmedica Osteonics Corp. (23); Exactech, Inc. (21).
Have LZO devices been recalled?
Yes: 177 product recalls across 69 recall events; the most recent began 2025-09-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LZO
- Run a recall and safety report across every LZO manufacturer
- Watch product code LZO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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