# K121777: U2 Acetabular Cup, Plasma Spray

- Pathway: 510(k) (Special)
- Applicant: United Orthopedic Corp.
- Decided: Jul 18, 2012 after 30 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941847 (1994). 24 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050262: U2 Acetabular Component, United Orthopedic Corp. (2005) Summary page 1.
- K063257: FMP Coated Spiked Acetabular Cup; Hemispherical Acetabular Cup; Flared Rim Acetabular Cup; Metal/Metal Acetabular Insert, Encore Medical L.P. (2006) Summary page 1.
- K031495: Pinnacle Duofix HA Acetabular Cup Prosthesis, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K921301: Taperloc Femoral Stem and Universal Acetabular Com, Biomet, Inc. (1994) Summary page 1.

## Most influential descendants
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own
- K170089: U-Motion II Acetabular System— Additional sizes (2017), 2 descendants of its own

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1381-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to

## Indications for use
The devise is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 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. Correction of function deformity; 4. Revision procedures where other treatments or devices have failed; and 5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques. The devise is intended for uncemented use and is single use only.

Source page: https://510kreport.com/device/K121777
Methodology: https://510kreport.com/methodology