# K033273: Depuy Pinnacle Acetabular Cup System, Esl Marathon Polyethylene Liners, and Depuy Ultima Unipolar Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 6, 2004 after 209 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.
210 later devices descend from it; 10 cite it directly.
0 of 211 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 Cup System Marathon Cross-Linked Polyethylene Liners: named in the summary without a submission number
- (no number) Biomet Tri-polar System: named in the summary without a submission number
- (no number) DePuy Ultima Unipolar Femoral Heads: named in the summary without a submission number
- (no number) DePuy Self-Centering Hip Prosthesis: named in the summary without a submission number

## Most influential descendants
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K062148: Depuy Pinnacle Altrx Acetabular Cup Liner (2006), 106 descendants of its own
- K062489: Apex Hcla Acetabular Cup  Liners (2007), 63 descendants of its own
- K111911: Corin Optimom Modular Head (2011), 62 descendants of its own
- K073150: Apex-LNK Poly Acetabular Cup Liners (2008), 62 descendants of its own

## Indications for use
The Pinnacle ® Enhanced Stability Liner (ESL) is indicated for use in total hip replacement procedures. 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. 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, or total hip replacement. 5. Certain cases of ankylosis. The Pinnacle ® ESL is indicated for use with the Pinnaclea' Acetabular Cup in cementless application.

Source page: https://510kreport.com/device/K033273
Methodology: https://510kreport.com/methodology