FDA product code LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LPH is the FDA product code for prosthesis, hip, semi-constrained, metal/polymer, porous uncemented. It is a Class II device, regulated under 21 CFR 888.3358 and reviewed by the Orthopedic panel. FDA has cleared 559 510(k) submissions under LPH, 44 in the last five years, from 124 different applicants. The average 510(k) review took 151 days (median 90); 170 days on average over the last three years. 3 PMA applications cite this product code. FDA has posted 297 recalls for LPH devices, 35 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3358 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LPH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 12 | 130 |
| 2018 | 9 | 183 |
| 2019 | 22 | 160 |
| 2020 | 7 | 181 |
| 2021 | 8 | 312 |
| 2022 | 14 | 266 |
| 2023 | 10 | 186 |
| 2024 | 6 | 114 |
| 2025 | 12 | 163 |
| 2026 | 2 | 234 |
Top LPH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zimmer, Inc. | 45 | 2026-02-04 |
| Biomet, Inc. | 43 | 2016-05-26 |
| Smith & Nephew, Inc. | 32 | 2024-10-07 |
| DePuy Orthopaedics, Inc. | 32 | 2020-10-21 |
| Depuy, Inc. | 24 | 2004-05-28 |
119 more applicants have LPH clearances. See the full list in Caduvo.
Most recent LPH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252623 | Zimmer, Inc. | G7® Revision Acetabular System | 2026-02-04 | 169 |
| K251043 | Medacta International S.A. | Mpact 3D Metal Implants Extension DMLS Technology | 2026-01-28 | 300 |
| K252067 | Restor3D, Inc. | Velora Acetabular System | 2025-12-05 | 157 |
| K252846 | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | TaperSet Hip System | 2025-11-20 | 73 |
| K251833 | Encore Medical L.P. | EMPOWR Acetabular® Liner Extension | 2025-11-12 | 149 |
Recalls for LPH devices
297 product recalls in 104 recall events; 35 initiated in the last five years and 52 still open. Most recent: 2026-01-05.
| Year | Recalls |
|---|---|
| 2017 | 22 |
| 2018 | 22 |
| 2019 | 12 |
| 2020 | 22 |
| 2021 | 21 |
| 2022 | 5 |
| 2023 | 5 |
| 2024 | 13 |
| 2025 | 7 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LPH?
LPH is the FDA product code for prosthesis, hip, semi-constrained, metal/polymer, porous uncemented. It is a Class II device, regulated under 21 CFR 888.3358 and reviewed by the Orthopedic panel.
What device class is LPH?
Class II, regulation 21 CFR 888.3358. Typical premarket route: 510(k).
How long does a 510(k) take for product code LPH?
Across 559 cleared submissions the average was 151 days from receipt to decision (median 90).
Which companies have the most LPH clearances?
Zimmer, Inc. (45); Biomet, Inc. (43); Smith & Nephew, Inc. (32); DePuy Orthopaedics, Inc. (32); Depuy, Inc. (24).
Have LPH devices been recalled?
Yes: 297 product recalls across 104 recall events; the most recent began 2026-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LPH
- Run a recall and safety report across every LPH manufacturer
- Watch product code LPH 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.