# K250450: Coated hip implants - Pathway: 510(k) (Traditional) - Applicant: Medacta International S.A. - Decided: Sep 19, 2025 after 213 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: 14 generations back to K941847 (1994). 324 ancestors in all. No later device cites it as a predicate yet. 0 of 324 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K103352: Versafitcup CC Trio, Medacta International (2011) Summary page 7. - K122911: Versafitcup CC Trio Extension, Medacta International (2012) Summary page 7. - K181254: Quadra P, Medacta International S.A. (2018) Summary page 7. - K192827: Quadra-P, Medacta International S.A. (2020) Summary page 7. - K202730: Quadra-P, Medacta International S.A. (2020) Summary page 7. - K161635: AMIStem-H Proximal Coating, Medacta International S.A. (2017) Summary page 7. - K173794: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, Medacta International S.A. (2018) Summary page 7. - K192126: AMIStem-P Short Neck, Medacta International S.A. (2019) Summary page 7. - K170845: MiniMAX, Medacta International S.A. (2017) Summary page 8. - K192352: MiniMAX, Medacta International S.A. (2019) Summary page 8. - K181693: SMS Femoral Stem, Medacta International S.A. (2018) Summary page 8. - K201673: SMS Cementless Stem, Medacta International S.A. (2020) Summary page 8. - K203041: SMS Cementless Stem, Medacta International S.A. (2020) Summary page 8. - K210263: Mpres Neck Preserving Stem, Medacta International S.A. (2021) Summary page 8. - K093944: Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra S, Medacta International S.A. (2010) Summary page 8. - K121011: Amistem and Quadra - Line Extension, Medacta International (2012) Summary page 8. - K082792: Medacta Total Hip Prosthesis System - Quadra H and R Femoral Stems, Medacta International S.A. (2008) Summary page 8. - K103721: Mpact Acetabular System, Medacta International (2011) Summary page 8. - K122641: Mpact Extension, Medacta International (2012) Summary page 8. - K132879: Mpact Extension, Medacta International (2014) Summary page 8. - K230011: Mpact Extension, Medacta International S.A. (2023) Summary page 8. ## Indications for use The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient’s condition should be due to one or more of: • Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. The hip prosthesis Quadra-P and Quadra-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The Quadra-P Cemented is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The MiniMax is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The hip prosthesis Quadra -S, Quadra-H and Quadra-R is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. The hip prosthesis Quadra-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The Quadra-C size 0 implant should not be implanted in patients with a mass of 65 kg or greater. The hip prosthesis SMS and SMS Collared are designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery. Total Hip Arthroplasty with the Mpres stem is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head. • Failure of previous hip surgery: • Conservative hip surgery, • Internal fixation, • Arthrodesis, • Hip resurfacing replacement. Partial hip arthroplasty with the Mpres stem is indicated in the following cases: • Acute traumatic fracture of the femoral head. • Avascular necrosis of the femoral head. • Primary pathology involving the femoral head but with a non-deformed acetabulum. The Mpact implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature. The patient’s condition should be due to one or more of: • Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia, ankylosing spondylitis. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. Source page: https://510kreport.com/device/K250450 Methodology: https://510kreport.com/methodology