# K141377: Bioball Delta Ceramic Heads, Multicup PE Inlay Standard

- Pathway: 510(k) (Traditional)
- Applicant: Merete Medical GmbH
- Decided: Nov 21, 2014 after 178 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K810258 (1981). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 155 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123619: Intrablock Bioball Hip System (Ibs), Merete Medical GmbH (2013) Summary page 3.
- K073567: Biolox Option Ceramic Femoral Head System, Model 8777 Series, Zimmer GmbH (2008) Summary page 4.
- K001534: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K000306: Pinnacle Acetabular System, DePuy Orthopaedics, Inc. (2000) Summary page 4.
- K093472: Trinity Acetabular System, Corin USA (2010) Summary page 4.

## Indications for use
The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty. The IBS is indicated for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, - Avascular necrosis of the femoral head, - 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. The IBS is indicated for cementless use only.

Source page: https://510kreport.com/device/K141377
Methodology: https://510kreport.com/methodology