# K090998: Depuy Pinnacle 100 with Gription Acetabular Cups

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jun 12, 2009 after 65 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: 5 generations back to K930712 (1993). 10 ancestors in all.
48 later devices descend from it; 4 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071784: Depuy Pinnacle with Gripton Acetabular Cups, DePuy Orthopaedics, Inc. (2007) Summary page 1.
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 1.

## Most influential descendants
- K093646: Depuy Pinnacle with Gription Acetabular Cups (2009), 31 descendants of its own
- K121297: Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series Acetabular Shell, Logical Acetabular (2012), 20 descendants of its own
- K170444: PROCOTYL® PRIME Acetabular Cup System (2017), 16 descendants of its own
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner (2017), 10 descendants of its own
- K221636: EMPHASYS Acetabular System (2022), 7 descendants of its own

## Indications for use
The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint 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, of total hip replacement. 5. Certain cases of ankylosis. Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications.

Source page: https://510kreport.com/device/K090998
Methodology: https://510kreport.com/methodology