# K163441: Locking Cage, Full XPE Cup

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Aug 25, 2017 after 260 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K955033 (1996). 193 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 196 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980774: Osteonics Gap-II Restoration Acetabular Shells, Osteonics Corp. (1998) Summary page 4.
- K991026: Reflection Crosslinked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (1999) Summary page 4.
- K122185: U-Motion II Acetabular System, United Orthopedic Corp. (2013) Summary page 4.
- K021911: Trident Crossfire Polyuethylene Liners, Howmedica Osteonics Corp. (2002) Summary page 5.

## Most influential descendants
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own
- K221149: U-Motion II Acetabular System-Extension line (2023), 1 descendant of its own
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own

## Indications for use
For Locking Cage 1. Revision of previous unsuccessful acetabular replacement. 2. Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures. For Full XPE Cup 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia; 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; 3. Correction of function deformity; 4. Revision procedures where other treatments or devices have failed; 5. Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques. This device is a single use implant and intended for cemented use only.

Source page: https://510kreport.com/device/K163441
Methodology: https://510kreport.com/methodology