# K181171: Zimmer Biomet Ceramic Heads

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 2, 2019 after 335 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K850055 (1985). 107 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151307: ICONACY (TM) I-Hip (TM), Iconacy Orthopedic Implants, LLC (2016) Summary page 4.
- K071535: Biolox Delta Ceramic Femoral Head, Zimmer, Inc. (2007) Summary page 4.
- K131684: Biolox (R) Delta Ceramic Heads, Biomet, Inc. (2013) Summary page 4.

## Most influential descendants
- K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I (2020), 1 descendant of its own
- K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own

## Recalls of this device
- Mar 24, 2025 · Class II · Z-1649-2025: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral 
- Mar 24, 2025 · Class II · Z-1648-2025: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral 
- Mar 24, 2025 · Class II · Z-1645-2025: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral 
- Mar 24, 2025 · Class II · Z-1646-2025: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral 
- Mar 24, 2025 · Class II · Z-1647-2025: The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral 

## Indications for use
The Zimmer Biomet™ Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. When used with constrained acetabular liners, the Zimmer Biomet™ Ceramic Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K181171
Methodology: https://510kreport.com/methodology