# K994078: U1 Hip System

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Dec 4, 2000 after 368 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.
50 later devices descend from it; 7 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy AML® Hip Prosthesis: named in the summary without a submission number

## 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
- K022520: U2 Acetabular Cup (2003), 14 descendants of its own
- K111546: U2 Hip System (2011), 13 descendants of its own
- K121777: U2 Acetabular Cup, Plasma Spray (2012), 9 descendants of its own

## Indications for use
This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; Inflammatory degenerative joint disease such as rheumatoid arthritis; Correction of function deformity; Revision procedures where other treatments or devices have failed; and Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Source page: https://510kreport.com/device/K994078
Methodology: https://510kreport.com/methodology