# K033338: Pinnacle Revision System

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 8, 2004 after 83 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
73 later devices descend from it; 4 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy Pinnacle Acetabular System: named in the summary without a submission number
- (no number) Summit Acetabular System: named in the summary without a submission number
- (no number) DePuy Duraloc Cementless Acetabular Cup System: named in the summary without a submission number
- (no number) Marathon Cross-Linked Polyethylene Acetabular Cup Liners: named in the summary without a submission number
- (no number) 36mm Marathon +4 Polyethylene Liners: named in the summary without a submission number
- (no number) Modified DePuy Acetabular System: named in the summary without a submission number

## Most influential descendants
- K071784: Depuy Pinnacle with Gripton Acetabular Cups (2007), 72 descendants of its own
- K090998: Depuy Pinnacle 100 with Gription Acetabular Cups (2009), 48 descendants of its own
- K093646: Depuy Pinnacle with Gription Acetabular Cups (2009), 31 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 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

## Indications for use
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Pinnacle Revision System is intended to be used to resurface the Acetabular socket in cemented or cementless total hip arthroplasty. The Pinnacle Revision System is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traunmatic 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 total hip replacement. 5. Certain cases of ankylosis. The Pinnacle Revision System Porocoat® porous-coated Acetabular Cup Shell components are indicated for cementless application.

Source page: https://510kreport.com/device/K033338
Methodology: https://510kreport.com/methodology