# K243809: Biolox® Delta Revision heads

- Pathway: 510(k) (Traditional)
- Applicant: Limacorporate
- Decided: Mar 4, 2025 after 83 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: 13 generations back to K810258 (1981). 197 ancestors in all.
No later device cites it as a predicate yet.
1 of 198 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213580: Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length, Total Joint Othopedics, Inc. (2021) Summary page 8.
- K192683: Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads, Biomet UK, Ltd. (2020) Summary page 8.
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 8.

## Indications for use
LimaCorporate Femoral modular heads are intended to be used in Total Hip arthroplasty with compatible femoral and acetabular components. - Coupling of femoral modular heads with DELTA Acetabular System is indicated for use 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 osteoarthritis, avascular necrosis and hip dysplasia; • Rheumatoid arthritis; • Post-traumatic arthritis, • Correction of functional deformity; • Fractures, dislocation of the hip and unsuccessful cup arthroplasty; • Revisions in cases of good remaining bone stock. • Revision of previously failed total hip arthroplasty (DELTA Multihole TT Pro only) The components are intended for use in cementless (press-fit) applications. - Coupling of femoral modular heads with H-MAX S, Minima S, Master SL, C2, MODULUS femoral stems is indicated 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 osteoarthritis, avascular necrosis and hip dysplasia; • rheumatoid arthritis; • osteoarthritis after femoral heads fractures (H-MAX S and Modulus stem); • treatment of femoral head and neck fractures (Minima S and MasterSL stems) • correction of functional deformity (MODULUS stems); • revisions in cases of good remaining femoral bone stock. The components are intended for use in cementless (press-fit) applications. - Coupling of femoral modular heads with Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. The components are intended for use in cementless (press-fit) applications. - Coupling of femoral modular heads with Cemented Cup is intended for cemented applications in hip arthroplasty where the acetabular socket needs reconstruction. LimaCorporate Lock Bipolar femoral heads are intended to be used in Partial Hip replacement with compatible femoral components (Minima S, Master SL, C2, MODULUS femoral stems) for cementless applications. This procedure is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: treatment of non-union, femoral neck fracture and intertrochanteric fractures unmanageable by other techniques.

Source page: https://510kreport.com/device/K243809
Methodology: https://510kreport.com/methodology