# K003237: U2 Hip Stem, TI Porous Coated

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Jan 10, 2001 after 85 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.
45 later devices descend from it; 5 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050262: U2 Acetabular Component (2005), 42 descendants of its own
- K123705: Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells (2013), 23 descendants of its own
- K121777: U2 Acetabular Cup, Plasma Spray (2012), 9 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own
- K152893: Corin Optimized Positioning System (OPS) (2016), 8 descendants of its own

Source page: https://510kreport.com/device/K003237
Methodology: https://510kreport.com/methodology