# K173898: MicroPort Orthopedics Total Hip Systems MR Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics Inc. (Mpo)
- Decided: Sep 20, 2018 after 272 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: 8 generations back to K930712 (1993). 81 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864626: Cancellous Bone Screw, Dow Corning Wright (1986) Summary page 14.
- K883618: Perfecta II Total Hip System, Orthomet, Inc. (1988) Summary page 14.
- K893685: Ceramic Femoral Head, Dow Corning Wright (1989) Summary page 14.
- K931333: Orthomet Acetabular Cup System, Orthomet, Inc. (1994) Summary page 14.
- K932222: SLT Femoral Head, Dow Corning Wright (1994) Summary page 14.
- K944752: Orthomet Resurfacing Femoral Component, Orthomet, Inc. (1994) Summary page 14.
- K953025: SLT 28MM XXL Femoral Head, Wrightmedicaltechnologyinc (1995) Summary page 14.
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 14.
- K003016: Pro-Femur R, Wrightmedicaltechnologyinc (2000) Summary page 14.
- K004032: Perfecta and Extend, Wrightmedicaltechnologyinc (2001) Summary page 14.
- K012091: Pro-Femur, Wrightmedicaltechnologyinc (2001) Summary page 14.
- K021346: Stem Hip Replacement System, Model PHA002XX, Wrightmedicaltechnologyinc (2002) Summary page 14.
- K043073: Procotyl-E Acetabular System, Wrightmedicaltechnologyinc (2005) Summary page 14.
- K051995: Profemur Renaissance Hip Stem, Wrightmedicaltechnologyinc (2005) Summary page 14.
- K052026: Lineage a-Class Poly Liner, Wrightmedicaltechnologyinc (2005) Summary page 14.
- K052915: Profemur XTR Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 14.
- K060358: Profemur TL Hip Stem, Wrightmedicaltechnologyinc (2006) Summary page 14.
- K061547: Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner, Wrightmedicaltechnologyinc (2006) Summary page 14.
- K062693: Gladiator Bipolar System, Wrightmedicaltechnologyinc (2006) Summary page 14.
- K062960: Conserve Femoral Resurfacing Component, Wrightmedicaltechnologyinc (2006) Summary page 14.
- K070785: Dynasty Acetabular System, Wrightmedicaltechnologyinc (2007) Summary page 14.
- K072656: Dynasty Ceramic Femoral Head, Wrightmedicaltechnologyinc (2008) Summary page 14.
- K082673: Conserve Pressfit Femoral Component, Wrightmedicaltechnologyinc (2008) Summary page 14.
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner, Wrightmedicaltechnologyinc (2009) Summary page 14.
- K091423: Profemur Hip System Modular Necks, Wrightmedicaltechnologyinc (2009) Summary page 14.
- K110399: Gladiator Plasma Classic Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 14.
- K111698: Profemur (R) E Cementless Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 14.
- K111699: Profemur (R) Z Titanium Plasma Sprayed Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 14.
- K111910: Gladiator Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 14.
- K112080: Preserve Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 14.
- K112150: Profemur Gladiator HA Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 14.
- K121221: Profemur Z Revision Hip Stem, Wrightmedicaltechnologyinc (2012) Summary page 14.
- K123434: Profemur Z Classic Stems, Wrightmedicaltechnologyinc (2013) Summary page 14.
- K123688: Profemur TL Classic Hip Stem, Wrightmedicaltechnologyinc (2013) Summary page 15.
- K130167: Profemur XM Distal Centralizer, Wrightmedicaltechnologyinc (2013) Summary page 15.
- K130376: Dynasty Acetabular System with Ceramic, Wrightmedicaltechnologyinc (2013) Summary page 15.
- K130984: Profemur Renaissance Classic Hip Stem, Wrightmedicaltechnologyinc (2013) Summary page 15.
- K140043: Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head, Microport Orthopedics, Inc. (2014) Summary page 15.
- K140676: Profemur TL Classic Long Neck Hip Stems, Microport Orthopedics, Inc. (2014) Summary page 15.
- K141235: Profemur Renaissance Classic Long Neck Hip Stems, Microport Orthopedics, Inc. (2014) Summary page 15.
- K142119: Procotyl L-O Acetabular System, Microport Orthopedics, Inc. (2015) Summary page 15.
- K150133: PROFEMUR Preserve Size 1-3 Hip Stems, Microport Orthopedics, Inc. (2015) Summary page 15.
- K150302: PROFEMUR Preserve Classic Stem, Microport Orthopedics, Inc. (2015) Summary page 15.
- K170444: PROCOTYL® PRIME Acetabular Cup System, Microport Orthopedics, Inc. (2017) Summary page 15.
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner, Microport Orthopedics, Inc. (2017) Summary page 15.

## Most influential descendants
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own

## Indications for use
CANCELLOUS BONE SCREW This cancellous bone screw is indicated for use where screw purchase with cancellous bone is required. PERFECTA II TOTAL HIP SYSTEM The Perfecta II Hip System is intended for cemented application only. The prosthesis system will be used in indications which are the same as indications for other cemented total hip designs such as the Zimmer Harris/Galante, the Biomet Bimetric, the Harris Precoat and the Howmedica Precision Hip System. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma or complications from failed prostheses. CERAMIC FEMORAL HEAD The McCutchen Femoral Hip Prothesis is indicated for relief of pain and restoration of hip function in skeletally mature patients with: bicompartmental joint disease secondary to osteoarthritis, rheumatoid arthritis or traumatic arthritis, avascular necrosis of the femoral head, painful hip dyplasia, acute fracture of the femoral neck, protrusio acetabuli, ankylosis, revision procedures for which an adequate fit may be achieved by the operating surgeon at the time of surgery. This hip stem prosthesis can be used with all short, medium, and long 28 and 32mm Ceramic Femoral Heads. ORTHOMET ACETABULAR CUP SYSTEM The intended use for the Orthomet Acetabular Cup System is identical to that of the acetabular cups of the Orthomet PERFECTA Total Hip System. The Orthomet Acetabular Cup is intended for cemented application only. Indications for the Orthomet Acetabular Cup will remain the same as indications for the original acetabular components of the PERFECTA Total Hip system and other acetabular cup systems currently available in commercial distribution, such as the Depuy Solution Acetabular Cup, Intermedics APR Acetabular Cup, Joint Medical Products S-ROM Acetabular Cup, Smith & Nephew Richards opti-Fix Acetabular Cup, and smith & Nephew Richards Reflection Acetabular Cup. Some indications include replacement of the femoral head and acetabular portions of the hip joint due to degenerative bone disease, trauma, or complications from failed prostheses. SLT FEMORAL HEAD This femoral head can only be used with stems labeled for use with this product, and the stem labeling should be consulted to determine its compatibility with this product. The SLT Femoral Head may be used with appropriately sized polyethylene-lined acetabular cups or bipolar endoprostheses. ORTHOMET RESURFACING FEMORAL COMPONENT The Orthomet Resurfacing Femoral Component (from this point forward referred to as the Resurfacing Femoral Component) is intended for single use in a cemented application only. The Resurfacing Femoral Component will be used in indications which are the same as indications for other commercially available femoral resurfacing components such as the Endotec Integrated Resurfacing Hip, DePuy Indiana Conservative Hip, DePuy T.A.R.A. Hemi Articular Hip Replacement, and Zimmer THARIES Surface Replacement System. Some indications include resurfacing of the femoral head portion of the hip joint due to avascular necrosis, degenerative bone disease, trauma, or complications from failed prostheses. SLT 28MM XXL FEMORAL HEAD The SLT 28mm XXL Femoral Head is indicated in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. LINEAGE ACETABULAR SYSTEM Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. PRO-FEMUR R Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. PERFECTA AND EXTEND Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. PRO-FEMUR Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) Inflammatory degenerative joint disease such as rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of fractures that are unmanageable using other techniques. PROCOTYL-E ACETABULAR SYSTEM The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of fractures that are unmanageable using other techniques. The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty. PROFEMUR RENAISSANCE HIP STEM The PROFEMUR® RENAISSANCE™ Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. LINEAGE A-CLASS POLY LINER Indications For Use: The LINEAGE® A-CLASS™ Poly Liner is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. PROFEMUR XTR HIP STEM The PROFEMUR® XTR Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. PROFEMUR TL HIP STEM The PROFEMUR® TL Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. DYNASTY ACETABULAR SHELL; DYNASTY A-CLASS POLY ACETABULAR LINER The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. GLADIATOR BIPOLAR SYSTEM The GLADIATOR® Bipolar System is indicated for the following conditions: 1. pathological fractures of the femoral neck. 2. non-union of femoral neck fractures. 3. aseptic necrosis of the femoral head and neck. 4. primary pathology in the young involving the femoral head but with non-deformed acetabulum. CONSERVE FEMORAL RESURFACING COMPONENT The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only. DYNASTY ACETABULAR SYSTEM The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The DYNASTY™ Acetabular Shell is for both cemented and uncemented use. DYNASTY CERAMIC FEMORAL HEAD The DYNASTY™ Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The DYNASTY™ Acetabular Shell is for both cemented and uncemented use. CONSERVE PRESSFIT FEMORAL COMPONENT The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use. DYNASTY POROUS ACETABULAR SHELL, POLYETHYLENE ACETABULAR LINER, METAL ACETABULAR LINER The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The size 50 and 54mm ceramic femoral heads are only intended for patients with giganticism or malunion of the acetabulum, and/or revision. The DYNASTY® Acetabular Shell is for both cemented and uncemented use and is a single use device. PROFEMUR HIP SYSTEM MODULAR NECKS The PROFEMUR® Hip System Modular Necks are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty. GLADIATOR PLASMA CLASSIC HIP STEM The GLADIATOR® Plasma Classic Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The GLADIATOR® Plasma Classic Hip Stem are intended for use during uncemented hip arthroplasty. PROFEMUR(R) E CEMENTLESS HIP STEM The PROFEMUR® E Cementless Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® E Cementless Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty. PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty. GLADIATOR HIP STEM 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Gladiator Cemented hip stem is intended for cemented hip arthroplasty. PRESERVE HIP STEM 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The Preserve hip stem is intended for cementless hip arthroplasty. PROFEMUR GLADIATOR HA HIP STEM 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty. PROFEMUR Z REVISION HIP STEM 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty. PROFEMUR Z CLASSIC STEMS The PROFEMUR® Z Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Z Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty. PROFEMUR TL CLASSIC HIP STEM The PROFEMUR® TL Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® TL Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty. PROFEMUR XM DISTAL CENTRALIZER The PMMA Distal Centralizers are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty. DYNASTY ACETABULAR SYSTEM WITH CERAMIC Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. PROFEMUR RENAISSANCE CLASSIC HIP STEM The PROFEMUR® RENAISSANCE® Classic Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® RENAISSANCE® Classic Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty. DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD The DYNASTY® Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. Shells with BIOFOAM metal foam coating are intended only for uncemented arthroplasty. Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. PROFEMUR TL CLASSIC LONG NECK HIP STEMS The PROFEMUR® TL Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® TL Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty. PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS The PROFEMUR® RENAISSANCE® Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® RENAISSANCE® Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty. PROCOTYL L-O ACETABULAR SYSTEM The PROCOTYL® L-O Acetabular System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROCOTYL® L-O Acetabular System utilizes single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty. PROFEMUR Preserve Size 1-3 Hip Stems The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty. PROFEMUR Preserve Classic Stem The PROFEMUR® Preserve Classic Stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed. The PROFEMUR® Preserve Classic Stems are single use components, intended for use in conjunction with associated ceramic femoral heads as part of uncemented total hip arthroplasty. PROCOTYL PRIME ACETABULAR CUP SYSTEM The PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. PROCOTYL® PRIME E-CLASS™ XLPE Liner The PROCOTYL® PRIME E-CLASS™ XLPE Liner is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

Source page: https://510kreport.com/device/K173898
Methodology: https://510kreport.com/methodology