Model note · Orthopedic Implants
DePuy PINNACLE Acetabular Cup System
PINNACLE is a modular acetabular (socket) system for total hip replacement, used by orthopaedic surgeons with cementless, porous-coated titanium alloy shells. Its distinctive feature is modularity: one shell family accepts several liner types, including cross-linked polyethylene (AltrX) and a cobalt-chrome dual mobility liner, matched to metal or ceramic femoral heads.
The model
Maker, model and type.
- Maker
- DePuy Orthopaedics, Inc. / DePuy Synthes (Johnson & Johnson MedTech)
- Model
- DePuy PINNACLE Acetabular Cup System (total hip)
- Device type
- Orthopedic Implants
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Shell material | Porous-coated hemispherical titanium alloy (Ti-6Al-4V) | Source |
| Fixation | Porous-coated shells indicated for cementless use | Source |
| Polyethylene liner (AltrX) | Cross-linked UHMWPE, irradiated to 7.5 Mrad and remelted; neutral, lateralised neutral, lipped or lateralised face-changing | Source |
| AltrX head size range | Femoral heads 28 to 48 mm | Source |
| Dual mobility liner | Cobalt-chrome-molybdenum liner, taper locked into PINNACLE shells, articulating with a BI-MENTUM polyethylene mobile bearing | Source |
| Regulation | Class II, 21 CFR 888.3358 and 888.3353, product codes LPH, LZO (MEH for dual mobility) | Source |
| Original clearance | K001534, June 2000 | Source |
Recalls
Known FDA recalls.
- Z-1366-20132012-03-07
One lot of AltrX liners had a box label that did not match the liner inside.
FDA record - Z-0569-20132012-11-28
Ten lots of PINNACLE cancellous screws carried the wrong description on the label.
FDA record - Z-0802-20212020-12-15
Some PINNACLE cups could have an oversized minor diameter, letting the Apex HE cross-thread through the shell.
FDA record
Safety
Safety warnings from the record.
- Where metal bearing or taper surfaces are involved, metal particles and ions such as cobalt and chromium can be released and cause adverse local tissue reactions that may need revision. Source
- FDA notes it cannot yet be predicted who will react to metal debris, how or when, so symptomatic patients need surgeon review. Source
- Dual mobility metal liners are for patients with enough sound bone to seat and support the components, and are single use only. Source
- Manufacturer wear claims for AltrX come from hip simulator studies and may not predict clinical wear. Source
Sources
Where this note comes from.
- FDA 510(k) K001534 summary, PINNACLE Acetabular System
- FDA 510(k) K072963 summary, PINNACLE AltrX liners
- FDA 510(k) K200854 summary, PINNACLE Dual Mobility Liner
- FDA, Concerns about metal-on-metal hip implants
- openFDA MAUDE problem counts, DePuy PINNACLE
- openFDA recalls, PINNACLE by DePuy
Not covered: No current DePuy Synthes product page or surgical technique was opened, so shell size range, screw options and the current liner line-up are not listed; MAUDE counts cover all PINNACLE configurations together, so they cannot be tied to one liner or bearing type.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Orthopedic Implants
Other models of this device.
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