# K200823: Zimmer, Inc. Hip Joint Prostheses MR Labeling I - Pathway: 510(k) (Traditional) - Applicant: Zimmer, Inc. - Decided: Jul 9, 2020 after 101 days - Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented) - Device class: 2 - Regulation: 21 CFR 888.3350 - Recalls of this device: 1 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 11 generations back to K850055 (1985). 188 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 189 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K191735: CPT Hip System, Zimmer, Inc. (2020) Summary page 15. - K051491: Trabecular Metal Primary Hip Prosthesis, Zimmer, Inc. (2005) Summary page 15. - K192660: Zimmer M/L Taper Hip Prosthesis, Zimmer, Inc. (2020) Summary page 15. - K113296: ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer, Zimmer, Inc. (2012) Summary page 15. - K181171: Zimmer Biomet Ceramic Heads, Zimmer, Inc. (2019) Summary page 15. - K972393: Inter-OP HA Porous Acetabular System (HA/Csti), Sulzer Orthopedics, Inc. (1997) Summary page 15. - K983509: Inter-OP Acetabular System - Durasul Acetabular Insert, Sulzer Orthopedics, Inc. (1999) Summary page 15. - K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads, Sulzer Orthopedics, Inc. (2000) Summary page 15. - K030923: Epsilon Durasul Constrained Acetabular Liner, Centerpulse Orthopedics, Inc. (2003) Summary page 15. - K061226: Trabecular Metal Acetabular Revision System Cage, Zimmer, Inc. (2006) Summary page 15. - K091508: Zimmer Continuum Acetabular System, Zimmer Trilogy IT Acetabular System, Zimmer, Inc. (2009) Summary page 15. - K093846: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Zimmer, Inc. (2010) Summary page 15. - K101229: Longevity IT Highly Crosslinked Polyethylene Elevated Liners, Continuum Acetabular System and Trilogy Integrated Taper, Zimmer, Inc. (2010) Summary page 15. - K103662: Continuum and Trilogy Integrated Taper (IT) Acetabular Systems; Longevity IT Highly Crosslinked Polyethylene Elevated LI, Zimmer, Inc. (2011) Summary page 15. - K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, Zimmer, Inc. (2012) Summary page 15. - K101730: Longevity IT Highly Crosslinked Polyethylene Constrained Liners, Zimmer, Inc. (2010) Summary page 15. ## Most influential descendants - K250834: Zimmer Biomet Ceramic Heads (22.2mm diameter) (2025), 0 descendants of its own ## Recalls of this device - Jul 26, 2023 · Class II · Z-2519-2023: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa. ## Indications for use • Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, posttraumatic arthritis, or avascular necrosis and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis • Those patients with failed previous surgery where pain, deformity, or dysfunction persists • Revision of previously failed hip arthroplasty Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. Primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The fixation method of the acetabular components with which this device is intended to be used is porous cementless with supplemental screws, and the fixation method of the femoral components with which this device is intended to be used is cemented, porous cementless, or non-porous cementless fixation, as indicated for use by each respective femoral component. This device is indicated for patients with conditions of, but not limited to: • Acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery. • Advanced joint destruction resulting from degenerative, post-traumatic, or rheumatoid arthritis. • Failed previous surgery, e.g., osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty, or total hip replacement. Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. The system is intended for use either with or without bone cement in total hip arthroplasty. The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered. The ZMR Hip System is indicated for cementless revision hip arthroplasty. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief or when there is progressive disability. The CPT Hip System is indicated for cemented use in: – Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. – Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. – Patients suffering from disability due to previous fusion. – Patients with previously failed endoprostheses and/or total hip components in the affected extremity. – Patients with acute femoral neck fractures. 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. Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected. The M/L Taper femoral stem is for cementless use only. Source page: https://510kreport.com/device/K200823 Methodology: https://510kreport.com/methodology