# K093646: Depuy Pinnacle with Gription Acetabular Cups

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Dec 17, 2009 after 22 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930712 (1993). 11 ancestors in all.
31 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090998: Depuy Pinnacle 100 with Gription Acetabular Cups, DePuy Orthopaedics, Inc. (2009) Summary page 1.
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 1.

## Most influential descendants
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), 20 descendants of its own
- K221636: EMPHASYS Acetabular System (2022), 7 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K133370: Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem, Evolve Distal Centralizer, Evolve CE (2014), 5 descendants of its own
- K192559: Acetabular Bone Screws (for MobileLink Acetabular Cup System) (2019), 4 descendants of its own

## Indications for use
DePuy Pinnacle with Gription Acetabular Cups are indicated for total hip replacement in the following conditions: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia; 2. Avascular necrosis of the femoral head; 3. Acute traumatic fracture of the femoral head or neck; 4. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and 5. Certain cases of ankylosis. Porous-coated Pinnacle Acetabular Cups are indicated for cementless application.

Source page: https://510kreport.com/device/K093646
Methodology: https://510kreport.com/methodology
