# K152530: UCP Stem

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corporation
- Decided: Mar 14, 2016 after 193 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: 7 generations back to K935452 (1994). 28 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082239: Depuy C-Stem Amt, DePuy Orthopaedics, Inc. (2008) Summary page 4.
- K030265: CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00, Zimmer, Inc. (2003) Summary page 4.

## Most influential descendants
- K250375: Allure Hip Stem and Intramedullary Plugs (2025), 0 descendants of its own
- K191056: Conformity stem, cemented (2020), 0 descendants of its own

## Indications for use
1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia. 2. Inflammatory degenerative joint disease such as rheumatoid arthritis. 3. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques. 4. Revision procedures where other treatments or devices have failed. 5. Patients suffering from disability due to previous fusion. 6. Patients with acute femoral neck fractures. This device is a single use implant and intended for cemented use only.

Source page: https://510kreport.com/device/K152530
Methodology: https://510kreport.com/methodology