# K211176: Smith & Nephew Hip Systems

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 1, 2022 after 437 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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: 9 generations back to K810258 (1981). 177 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 31.
- K171934: Birmingham Hip (BH) Dual Mobility Insert, Smith & Nephew, Inc. (2017) Summary page 31.
- K962541: Reflection Acetabular Reinforcement Rings, Smith & Nephew Richards, Inc. (1996) Summary page 31.
- K040680: Contour HA Coated Reconstruction Ring, Smith & Nephew, Inc. (2004) Summary page 31.
- K970351: Global Taper Spectron Hip Stems, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 31.
- K823727: Spectron Primary Stem Femoral Prosthes, Richard'S Medical Equip., Inc. (1983) Summary page 31.
- K983834: Echelon Hip Stem, Smith & Nephew, Inc. (1999) Summary page 31.
- K023302: Echelon Porous Plus HA Hip Stems, Smith & Nephew, Inc. (2002) Summary page 31.
- K963486: Revision Hip System, Smith & Nephew Richards, Inc. (1996) Summary page 31.
- K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002) Summary page 31.
- K022902: Smith & Nephew Hip System, Smith & Nephew, Inc. (2002) Summary page 31.
- K022958: Total Hip Femoral Heads and Liners, Smith & Nephew, Inc. (2002) Summary page 31.
- K072817: Echelon Titanium Hip System, Smith & Nephew, Inc. (2008) Summary page 31.
- K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 31.
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners, Smith & Nephew, Inc. (2010) Summary page 31.
- K100412: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2010) Summary page 31.
- K110101: Taper Oxinium Femoral Head, Smith & Nephew, Inc. (2011) Summary page 31.
- K914878: Zirconium Alloy Frmoral Head, Smith & Nephew Richards, Inc. (1992) Summary page 31.
- K963509: Global Taper Tapered Hip System, GT Spectron, Smith & Nephew Richards, Inc. (1997) Summary page 31.
- K971414: Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral Heads, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 31.
- K093991: SLR-Plus Standard and Lateral Femoral Stems, Smith & Nephew, Inc. (2010) Summary page 31.
- K921400: Hip Joint Prothesis, Smith & Nephew Richards, Inc. (1993) Summary page 32.
- K900628: Modular Hip System, Richards Medical Co., Inc. (1990) Summary page 32.
- K070278: Polarcup Dual Mobility System, Plus Orthopedics AG (2007) Summary page 32.
- K110135: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2011) Summary page 32.
- K122244: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2012) Summary page 32.
- K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA, Smith & Nephew, Inc. (2013) Summary page 32.
- K143739: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA, Smith & Nephew, Inc. (2015) Summary page 32.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 32.
- K083566: R3 Constrained Liner, Constrained Liner, Smith & Nephew, Inc. (2009) Summary page 32.
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009) Summary page 32.
- K102370: R3 Xlpe Anteverted Liners, Smith & Nephew, Inc. (2011) Summary page 32.
- K113848: R3 Xlpe Liners, Smith & Nephew, Inc. (2012) Summary page 32.
- K182535: R3 Anteverted Liners, Smith & Nephew, Inc. (2018) Summary page 32.
- K081124: MDF Revision Hip System, Smith & Nephew, Inc. (2008) Summary page 32.
- K100481: Smith & Nephew MDF Modular Sleeve, Smith & Nephew, Inc. (2010) Summary page 32.
- K121627: Smith & Nephew Redapt Revision Femoral System, Smith & Nephew, Inc. (2012) Summary page 32.
- K151902: REDAPT¿ Revision Femoral System, Smith & Nephew, Inc. (2015) Summary page 32.
- K162303: REDAPT Sleeved Monolithic Revision Stems, Smith & Nephew, Inc. (2017) Summary page 32.
- K150790: REDAPT Porous Acetabular Shell and Cemented Liner, Smith & Nephew, Inc. (2015) Summary page 32.
- K160923: REDAPT Anteverted Cemented Liner, Smith & Nephew, Inc. (2016) Summary page 32.
- K171073: Smith & Nephew, Inc. REDAPT Augments, Smith & Nephew, Inc. (2017) Summary page 32.
- K182109: REDAPT Modular Acetabular Shell, Smith & Nephew, Inc. (2018) Summary page 32.
- K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 32.
- K021803: Reflection Constrained Liner, Smith & Nephew, Inc. (2002) Summary page 32.
- K022556: Reflection Modified Acetabular Shells, Smith & Nephew, Inc. (2002) Summary page 32.
- K033442: Reflection Constrained Liner, Smith & Nephew, Inc. (2003) Summary page 32.
- K071160: Reflection, Tandem Unipolar, Smith & Nephew, Inc. (2007) Summary page 32.
- K920430: Modular Acetabular Cup System, Smith & Nephew Richards, Inc. (1992) Summary page 32.
- K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 32.
- K990666: Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit Shell, Smith & Nephew, Inc. (1999) Summary page 32.
- K960094: Reflection Dual Dimension Shell, Smith & Nephew Richards, Inc. (1996) Summary page 32.
- K103256: Smith & Nephew SMF Hip Stem, Smith & Nephew, Inc. (2011) Summary page 32.
- K123012: Smith & Nephew SMF Hip Stem, Smith & Nephew, Inc. (2012) Summary page 32.
- K072852: SL-Plus Standard and Lateral Hip Stems, Smith & Nephew, Inc. (2008) Summary page 32.
- K120211: SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 32.
- K122296: SL-Plus Mia Femoral Stems with TI/HA Coating, Smith & Nephew, Inc. (2012) Summary page 32.
- K823723: Spectron Proximal Femoral Prosthesis, Richard'S Medical Equip., Inc. (1983) Summary page 33.
- K831884: Spectron Extra-Small, Straight Femoral, Richards Manufacturer Co. (1983) Summary page 33.
- K791125: Plug-Lok Cement Restirctor, Richard'S Medical Equip., Inc. (1979) Summary page 33.
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000) Summary page 33.
- K970337: HA Global Taper (GT) Tapered Hip Stem, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 33.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 33.
- K991485: Synergy Porous Size 8 Hip Stem, Smith & Nephew, Inc. (1999) Summary page 33.
- K023743: Smith & Nephew Global Bipolar System, Smith & Nephew, Inc. (2003) Summary page 33.
- K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 33.
- K934353: Zirconium Alloy Uni-Polar Head, Smith & Nephew Richards, Inc. (1994) Summary page 33.

## Most influential descendants
- K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (2024), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own
- K231448: TANDEM Hip System (2023), 0 descendants of its own

## Recalls of this device
- Oct 15, 2024 · Class II · Z-0326-2025: The Bipolar assembly contains an oversized Retainer Ring.

## Indications for use
The components are indicated for the following: 1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; 2. Rheumatoid arthritis; 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. Revision procedures where other treatment or devices have failed; and 5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The components 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, and intra-operative instability and for whom all other options to constrained acetabular components have been considered. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head 3. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement. 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head 3. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement 4. All forms of osteoarthritis 5. Patients with hips at risk of dislocation 6. Femoral neck fracture or proximal fracture to hip joint The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only. The indications for use in total hip arthoplasty include rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Source page: https://510kreport.com/device/K211176
Methodology: https://510kreport.com/methodology