# K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics
- Decided: Apr 18, 2024 after 101 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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). 120 ancestors in all.
No later device cites it as a predicate yet.
2 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002149: Lineage Acetabular System, Wrightmedicaltechnologyinc (2000) Summary page 4.
- K052026: Lineage a-Class Poly Liner, Wrightmedicaltechnologyinc (2005) Summary page 5.
- K061547: Dynasty Acetabular Shell; Dynasty a-Class Poly Acetabular Liner, Wrightmedicaltechnologyinc (2006) Summary page 6.
- K062693: Gladiator Bipolar System, Wrightmedicaltechnologyinc (2006) Summary page 7.
- K070785: Dynasty Acetabular System, Wrightmedicaltechnologyinc (2007) Summary page 8.
- K072656: Dynasty Ceramic Femoral Head, Wrightmedicaltechnologyinc (2008) Summary page 9.
- K111910: Gladiator Hip Stem, Wrightmedicaltechnologyinc (2011) Summary page 10.
- K140043: Dynasty Shell, Dynasty a-Class Crosslinked Poly Liner, Biolox Delta Femoral Head, Microport Orthopedics, Inc. (2014) Summary page 11.
- K142119: Procotyl L-O Acetabular System, Microport Orthopedics, Inc. (2015) Summary page 12.
- K170444: PROCOTYL® PRIME Acetabular Cup System, Microport Orthopedics, Inc. (2017) Summary page 13.
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner, Microport Orthopedics, Inc. (2017) Summary page 14.
- K180798: Prime Acetabular Cup System, Microport Orthopedics, Inc. (2018) Summary page 16.
- K181598: Prime E-CLASS XLPE Liner, Microport Orthopedics, Inc. (2018) Summary page 17.
- K200011: E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS, Microport Orthopedics, Inc. (2021) Summary page 18.
- K892398: Bipolar Hip System, Orthomet, Inc. (1989) Summary page 19.
- K911052: Nexus (TM) Femoral Hip Stem, Dow Corning Wright (1991) Summary page 20.
- K923909: Cement Restrictor for Proforma and Perfecta Total, Orthomet, Inc. (1992) Summary page 21.
- K931333: Orthomet Acetabular Cup System, Orthomet, Inc. (1994) Summary page 22.
- K173776: BIOLOX delta Option and Extra-long Heads, Microport Orthopedics, Inc. (2018) Summary page 15.

## Indications for use
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 osteoarthlitis, 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 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 The DYNASTYTM 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 GLADIATORTm 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 a non-deformed acetabulum. 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. The DYNASTYTM 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 DYNASTYTM Acetabular Shell is for both cemented and uncemented use. The Gladiator Hip Stems are intended for use in uncemented and cemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use 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 Cemented hip stem is intended for cemented hip arthroplasty. MicroPort 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 Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty 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 conjuction with associated ceramic femoral heads as part of uncemented total hip arthroplasty. 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 hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use 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. MicroPort total hip systems 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. Indications for Use 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. Indications for Use 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. The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced. Indications for Use: 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; 5) dislocation risks; 6) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement which are unmanageable by other techniques Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty. The Bipolar Hip System is intended for cemented and cementless applications. Some indications include replacement of the femoral head of the hip joint due to degenerative bone disease, trauma, non-union or avascular necrosis. The NEXUS Femoral Hip Prosthesis 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 dysplasia, acute fracture of the femoral neck, protrusio acetabuli, ankylosis, and revision procedures for which an adequate fit may be achieved by the operating surgeon at the time of surgery. The Orthomet Cement Restrictor is intended to be used with the PROFORMA and PERFECTA Femoral Stems as part of the PROFORMA and PERFECTA Total Hip Systems. The intended use of the Orthomet PROFORMA and PERFECTA Femoral Stems implanted with the Cement Restrictor will remain the same as indications for femoral stems implanted without the Cement Restrictor. Some indications include replacement of the femoral head of the hip joint due to degenerative bone disease, trauma, non-union, avascular necrosis, or complications from failed prostheses. The Orthomet Cement Restrictor is designed to prevent the bone cement from extruding down the medullary canal, during cemented application, when the femoral stem is inserted or the cement is pressurized. 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.

Source page: https://510kreport.com/device/K240046
Methodology: https://510kreport.com/methodology