| K-number | K252623 |
| Device name | G7® Revision Acetabular System |
| Applicant | Zimmer, Inc. |
| Product code | LPH |
| Device class | Class II |
| Decision date | Feb 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3358 |
The G7® TM Acetabular System is an uncemented hip joint prosthesis consisting of a Trabecular Metal-coated titanium acetabular shell with multi-screw hole patterns and Rim Fix titanium screws. It is intended for total hip arthroplasty in skeletally mature patients with conditions including osteoarthritis, rheumatoid arthritis, avascular necrosis, and revision procedures where other treatments have failed.
The subject device shares the same intended use, indications for use, sterilization method, and similar materials and design as the predicate device (K140669, G7® OsseoTi Acetabular Shells). The differences in technological characteristics do not introduce new questions of safety and effectiveness. The shells are made from Tivanium (Ti-6Al-4V ELI Alloy) per ASTM F136-13 with a porous Tantalum pad (Trabecular Metal) per ASTM F560-22 diffusion bonded to the exterior.
ASTM F3090-24 (fatigue), ASTM F1875-98 (fretting corrosion), ISO 21535:2023 (range of motion), ASTM F1820-22 (liner disassembly), ISO 14242-1:2014 (wear), ASTM F2182-2019e2/F2052-21/F2213-17/F2119-24/F2503-23e1 (MRI safety), ISO 7206-12:2016 (shell deformation), ASTM F543-23:2023 (screw torque/pull-out), ASTM F1839-08:2021 and ASTM F3090-24:2024 (screw micromotion).
The G7® TM Acetabular System is substantially equivalent to the predicate device because it has identical intended use and indications for use, employs the same or substantially similar technological characteristics, and is intended for the same uncemented biological fixation application. Non-clinical performance testing demonstrates comparable safety and effectiveness profiles with no new safety or effectiveness questions introduced by design differences.
View the full FDA submission: accessdata.fda.gov