# K112463: United 36MM Ceramic Femoral Head, Delta

- Pathway: 510(k) (Special)
- Applicant: United Orthopedic Corporation
- Decided: Sep 23, 2011 after 28 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K810258 (1981). 40 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103497: Ceramic Femoral Head, United Orthopedic Corp. (2011) Summary page 1.
- K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 1.
- K100412: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2010) Summary page 1.
- K042091: Biolox Delta Ceramic Heads, Biomet, Inc. (2005) Summary page 1.
- K061312: 36MM Biolox Delta Ceramic Heads, Biomet, Inc. (2006) Summary page 1.
- K051411: Arcomxl Polyethylene Liners and Biolox Delta Heads, Biomet, Inc. (2005) 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-1386-2013: 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
This device is indicated for use in total hip arthroplasty for the following conditions: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques; revision procedures where other treatment or devices have failed arthroplasty or other procedure.

Source page: https://510kreport.com/device/K112463
Methodology: https://510kreport.com/methodology