# K070479: Exactech Novation Crown Cup and Liners - Pathway: 510(k) (Special) - Applicant: Exactech, Inc. - Decided: Mar 15, 2007 after 23 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: 16 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 6 generations back to K931641 (1994). 20 ancestors in all. 59 later devices descend from it; 6 cite it directly. 0 of 80 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component, Exactech, Inc. (1999) Summary page 2. - K000242: Acumatch a-Series Corundum Acetabular Component and Acumatch a-Series Corundum Acetabular Component with Hydroxyapatite, Exactech, Inc. (2000) Summary page 2. - K051556: Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene, Exactech, Inc. (2005) Summary page 2. ## Most influential descendants - K102975: Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole (2010), 53 descendants of its own - K122798: Integrip Acetabular Shell, Integrip Revision Acetabular Shell (2012), 36 descendants of its own - K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own - K112898: Delta TT Cups, Delta TT Liners, Bone Screws (2012), 12 descendants of its own - K141395: Delta TT Acetabular System (2014), 10 descendants of its own ## Recalls of this device - Aug 11, 2022 · Class II · Z-1729-2022: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. - Jun 29, 2021 · Class II · Z-2121-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2122-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2117-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2131-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2128-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2118-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2132-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2116-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2126-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2120-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2133-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2127-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Jun 29, 2021 · Class II · Z-2123-2021: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. - Nov 5, 2012 · Class II · Z-0787-2013: Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the devic - Nov 5, 2012 · Class II · Z-0788-2013: Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the devic ## Indications for use All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. * Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. * Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon. * Femoral heads and endoprostheses are intended for use in cemented and press-fit applications. Source page: https://510kreport.com/device/K070479 Methodology: https://510kreport.com/methodology