# K011887: Avalon Cup System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Source, Inc.
- Decided: Dec 27, 2001 after 192 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
No predicates in its family tree.
71 later devices descend from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022711: Modification to Avalon Cup System (2002), 70 descendants of its own
- K060635: Consensus Acetabular Shell System (2006), 69 descendants of its own
- K112802: Pipeline Total Hip System (2012), 53 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own
- K141043: CS2 Multi-Hole Acetabular Shell (2014), 21 descendants of its own

## Indications for use
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following: 1) Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia, 2) Inflammatory degenerative joint disease including rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K011887
Methodology: https://510kreport.com/methodology