# K960340: Consensus Apex Dome Hole Plug

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Medical Products, Inc.
- Decided: Mar 15, 1996 after 51 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: 1 generation back to K922561 (1993). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922561: Consensus (TM) Total Hip System, U.S. Medical Products, Inc. (1993) Summary page 1.

## Most influential descendants
- K111472: Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon (2011), 4 descendants of its own
- K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert (2012), 1 descendant of its own
- K191826: KeYi Total Hip System (2020), 0 descendants of its own
- K150576: TGM Biolox delta Ceramic Heads (2015), 0 descendants of its own
- K121509: Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert (2012), 0 descendants of its own

## Indications for use
The CONSENSUS® Apex Dome Hole Plug (PMMA) is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis and avascular necrosis with a non-acute fracture of the femoral neck. Osteoarthrosis involving femoral and acetabular articular surfaces. . Avascular osteonecrosis and/or non-union of acute femoral neck fractures. . Fracture-dislocation of the hip. Replacement of unsatisfactory cemented or press fit hip components if sufficient bone stock exists.

Source page: https://510kreport.com/device/K960340
Methodology: https://510kreport.com/methodology