Product code LPH: 510(k) clearances and predicates
Product code LPH covers G7® Acetabular System. FDA lists 565 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
565 clearances on file under product code LPH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 14 |
| 2023 | 10 |
| 2024 | 6 |
| 2025 | 12 |
| 2026 so far | 8 |
Recent clearances
Newest LPH clearances in the FDA index, with applicant and decision date:
- K261453, G7® Acetabular System, applicant Zimmer Biomet, decided 2026-09-23. FDA record
- K253630, Mpact 3D Metal Foam, applicant Medacta International S.A., decided 2026-08-28. FDA record
- K254043, TRIVANCE Hip Stem, applicant Globus Medical, Inc., decided 2026-08-04. FDA record
- K261624, Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component, applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics, decided 2026-07-10. FDA record
- K243192, iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating, applicant Nextstep Arthopedix, LLC, decided 2026-06-05. FDA record
- K251270, Taperloc® Complete Hip Stem, applicant Biomet, Inc., decided 2026-05-19. FDA record
- K252623, G7® Revision Acetabular System, applicant Zimmer, Inc., decided 2026-02-04. FDA record
- K251043, Mpact 3D Metal Implants Extension DMLS Technology, applicant Medacta International S.A., decided 2026-01-28. 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 Mpact 3D Metal Foam, TRIVANCE Hip Stem. Watch new LPH 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 LPH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LPH clearances include G7® Acetabular System.
How many 510(k) clearances use product code LPH?
565 at the time this page was generated, from openFDA records.
How do I find a predicate device under LPH?
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 LPH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.