# K123598: Smith & Nephew, Inc. Hip System Instrumentation - Pathway: 510(k) (Traditional) - Applicant: Smith & Nephew, Inc. - Decided: Jun 28, 2013 after 219 days - Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented) - Device class: 2 - Regulation: 21 CFR 888.3350 - Recalls of this device: 2 (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). 263 ancestors in all. No later device cites it as a predicate yet. 0 of 263 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K823722: Spectron Long, Straight Femoral Prosthes, Richard'S Medical Equip., Inc. (1983) Summary page 1. - K823727: Spectron Primary Stem Femoral Prosthes, Richard'S Medical Equip., Inc. (1983) Summary page 1. - K823723: Spectron Proximal Femoral Prosthesis, Richard'S Medical Equip., Inc. (1983) Summary page 1. - K823724: Spectron Neck Replacement Prosthesis, Richard'S Medical Equip., Inc. (1983) Summary page 1. - K831884: Spectron Extra-Small, Straight Femoral, Richards Manufacturer Co. (1983) Summary page 1. - K873797: TI-Fit Total Hip System, Richards Medical Co., Inc. (1987) Summary page 1. - K912593: Modular Hip System, Smith & Nephew Richards, Inc. (1991) Summary page 1. - K914343: TI-Fit Femoral Component, Smith & Nephew Richards, Inc. (1992) Summary page 1. - K963486: Revision Hip System, Smith & Nephew Richards, Inc. (1996) Summary page 1. - K963509: Global Taper Tapered Hip System, GT Spectron, Smith & Nephew Richards, Inc. (1997) Summary page 1. - K970337: HA Global Taper (GT) Tapered Hip Stem, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1. - K970351: Global Taper Spectron Hip Stems, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1. - K982447: Plus Bipolar Prosthesis Cocrmo, Plus Orthopedics (1998) Summary page 1. - K983834: Echelon Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1. - K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1. - K991485: Synergy Porous Size 8 Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1. - K994126: Modular-Plus Revision Stem, Plus Orthopedics (2000) Summary page 1. - K001942: SL-Plus and SLR-Plus Stems, Plus Orthopedics (2000) Summary page 1. - K002996: Synergy HA Coated Porous Femoral Stems, Smith & Nephew, Inc. (2000) Summary page 2. - K021178: SL-Plus Lateralized Stem, Plus Orthopedics (2002) Summary page 2. - K023302: Echelon Porous Plus HA Hip Stems, Smith & Nephew, Inc. (2002) Summary page 2. - K024134: Uni Hip Stem, Plus Orthopedics (2003) Summary page 2. - K030971: Modification to Modular Plus Revision Stem, Plus Orthopedics (2003) Summary page 2. - K031165: Plus Orthopedics Cemented Hip Stem, Plus Orthopedics (2003) Summary page 2. - K032709: Modular Plus Hip Stem, Plus Orthopedics (2003) Summary page 2. - K042127: Smith & Nephew Modular Hip, Smith & Nephew, Inc. (2004) Summary page 2. - K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 2. - K052275: Smith & Nephew Platform Hip Stem, Smith & Nephew, Inc. (2005) Summary page 2. - K052426: Smith & Nephew Modular Hip, Smith & Nephew, Inc. (2005) Summary page 2. - K053246: Patient Matched Hip Stem, Smith & Nephew, Inc. (2006) Summary page 2. - K080625: Smith & Nephew Mis Hip Stem with Stiktite, Smith & Nephew, Inc. (2008) Summary page 2. - K072817: Echelon Titanium Hip System, Smith & Nephew, Inc. (2008) Summary page 2. - K072852: SL-Plus Standard and Lateral Hip Stems, Smith & Nephew, Inc. (2008) Summary page 2. - K082371: Smith & Nephew SL-Plus Mia Standard and Lateral Femoral Hip Stem, Smith & Nephew, Inc. (2009) Summary page 2. - K093991: SLR-Plus Standard and Lateral Femoral Stems, Smith & Nephew, Inc. (2010) Summary page 2. - K100481: Smith & Nephew MDF Modular Sleeve, Smith & Nephew, Inc. (2010) Summary page 2. - K103256: Smith & Nephew SMF Hip Stem, Smith & Nephew, Inc. (2011) Summary page 2. - K896580: Uni-Polar Head, Richards Medical Co., Inc. (1990) Summary page 2. - K914878: Zirconium Alloy Frmoral Head, Smith & Nephew Richards, Inc. (1992) Summary page 2. - K934353: Zirconium Alloy Uni-Polar Head, Smith & Nephew Richards, Inc. (1994) Summary page 2. - K981847: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (1998) Summary page 2. - K990309: Plus Fracture Head Prosthesis, Plus Orthopedics (1999) Summary page 2. - K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia), Plus Orthopedics (1999) Summary page 2. - K991162: Biolox Alumina Ceramic Femoral Head, Smith & Nephew, Inc. (2000) Summary page 2. - K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002) Summary page 2. - K022958: Total Hip Femoral Heads and Liners, Smith & Nephew, Inc. (2002) Summary page 2. - K061243: Smith & Nephew Modular Femoral Head, Smith & Nephew, Inc. (2006) Summary page 2. - K062408: Smith & Nephew Modular Femoral (Hemi) Head, Smith & Nephew, Inc. (2006) Summary page 2. - K070928: Ceramic Ball Heads, 28, 32 and 36 MM, Plus Orthopedics AG (2007) Summary page 2. - K081566: Smith & Nephew Oxinium DH Femoral Heads, Smith & Nephew, Inc. (2008) Summary page 2. - K083762: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2009) Summary page 2. - K100412: Biolox Delta Ceramic Femoral Heads, Smith & Nephew, Inc. (2010) Summary page 2. - K110101: Taper Oxinium Femoral Head, Smith & Nephew, Inc. (2011) Summary page 2. - K823725: Spectron Protrusio Cup, Richard'S Medical Equip., Inc. (1983) Summary page 3. - K823729: Spectron Metal Back Acetabular Component, Richard'S Medical Equip., Inc. (1983) Summary page 3. - K823728: Spectron Polyethylene Acctubular Compon, Richard'S Medical Equip., Inc. (1983) Summary page 3. - K860275: TI-Fit Acetabular Component, Richards Medical Co., Inc. (1986) Summary page 3. - K864857: Opti-Fix Acetabular Component, Richards Medical Co., Inc. (1987) Summary page 3. - K874619: Spectron EF Acetabular Component, Richards Medical Co., Inc. (1988) Summary page 3. - K920430: Modular Acetabular Cup System, Smith & Nephew Richards, Inc. (1992) Summary page 3. - K922621: HA TI-Fit Acetabular and Femoral Component, Smith & Nephew Richards, Inc. (1994) Summary page 3. - K932755: Reflection Acetabular Component, Smith & Nephew Richards, Inc. (1994) Summary page 3. - K960094: Reflection Dual Dimension Shell, Smith & Nephew Richards, Inc. (1996) Summary page 3. - K973077: Plus-Fit Acetabular Cup, Plus Orthopedics (1997) Summary page 3. - K972931: Plus Epf Acetabular Cup, Hhl Consulting (1997) Summary page 3. - K991538: Opera Cupflanged Acetabular Components, Smith & Nephew, Inc., Orthopaedic Div. (1999) Summary page 3. - K990666: Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit Shell, Smith & Nephew, Inc. (1999) Summary page 3. - K992153: PE-Plus Acetabular Cup, Plus Orthopedics (1999) Summary page 3. - K992154: Bicon-Plus Acetabular Components, Plus Orthopedics (2000) Summary page 3. - K993874: Bofor Revision Coup, Plus Orthopedics (2000) Summary page 3. - K994146: Epf-Plus Cementless Press-Fit Acetabular Cup, Plus Orthopedics (2000) Summary page 3. - K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 3. - K003274: LPC-Plus Acetabular Cup, Plus Orthopedics (2001) Summary page 3. - K011836: MPF Acetabular Cup, Plus Orthopedics (2001) Summary page 3. - K022120: MPF Acetabular Cup Generation 2, Plus Orthopedics (2002) Summary page 3. - K022556: Reflection Modified Acetabular Shells, Smith & Nephew, Inc. (2002) Summary page 3. - K022902: Smith & Nephew Hip System, Smith & Nephew, Inc. (2002) Summary page 3. - K021803: Reflection Constrained Liner, Smith & Nephew, Inc. (2002) Summary page 3. - K033442: Reflection Constrained Liner, Smith & Nephew, Inc. (2003) Summary page 3. - K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 3. - K060630: Reflection 3-Hole Shell with Asymmetric Porous Coating, Smith & Nephew, Inc. (2006) Summary page 3. - K070278: Polarcup Dual Mobility System, Plus Orthopedics AG (2007) Summary page 3. - K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 3. - K071160: Reflection, Tandem Unipolar, Smith & Nephew, Inc. (2007) - K083566: R3 Constrained Liner, Constrained Liner, Smith & Nephew, Inc. (2009) Summary page 3. - K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009) Summary page 3. - K092098: Patient Specific Acetabular Reconstruction Prosthesis, Smith & Nephew, Inc. (2010) Summary page 3. - K102370: R3 Xlpe Anteverted Liners, Smith & Nephew, Inc. (2011) Summary page 3. - K823726: Spectron Conversion Endoprosthesis Cup, Richard'S Medical Equip., Inc. (1983) Summary page 4. - K842977: Orthopaedic Cable System, Richards Medical Co., Inc. (1984) Summary page 4. - K860635: Opti-Fix Total Hip System, Richards Medical Co., Inc. (1986) Summary page 4. - K870128: Hartford Total Hip System (Tri-Wedge), Richards Medical Co., Inc. (1987) Summary page 4. - K875156: Stainless Steel Orthopaedic Cable System, Richards Medical Co., Inc. (1988) Summary page 4. - K874868: Opti-Fix Collared Femoral Components, Richards Medical Co., Inc. (1988) Summary page 4. - K913916: Hydroxylapatite Coated TI-Fit Femoral Component, Smith & Nephew Richards, Inc. (1991) Summary page 4. - K921400: Hip Joint Prothesis, Smith & Nephew Richards, Inc. (1993) Summary page 4. - K962541: Reflection Acetabular Reinforcement Rings, Smith & Nephew Richards, Inc. (1996) Summary page 4. - K031162: Smith & Nephew Orthopaedic Cabling System, Smith & Nephew, Inc. (2003) Summary page 4. - K040680: Contour HA Coated Reconstruction Ring, Smith & Nephew, Inc. (2004) Summary page 4. - K043252: Cabling System Trochanter Hook, Smith & Nephew, Inc. (2005) Summary page 4. - K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners, Smith & Nephew, Inc. (2010) Summary page 4. ## Cited in the summary but kept off the family tree - K834592: Ti-Thread Acetabular Component. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3. ## Recalls of this device - Jan 7, 2019 · Class II · Z-0730-2019: The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble. - Nov 16, 2016 · Class II · Z-1008-2017: The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound. ## Indications for use Smith & Nephew Uncemented Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Uncemented Hip Systems and their cleared Indications for Use. Uncemented Femoral Stems are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Cemented Femoral Stem instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Cemented Hip Systems and their cleared Indications for Use. Cemented Femoral Stems are indicated for cemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew PLUS Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use. Smith & Nephew Inc PLUS Femoral Stems are indicated for: The Plus Bipolar prosthesis CoCrMo is intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only. The Modular-PLUS Revision Stem is intended for cementless use in fractures of the femur where a long section of bone is damaged and the stem must anchor into the distal half of the femur. The SL-PLUS Stem Primary is intended for treating patients who are candidate for total hip arthroplasty because the natural femoral head and neck has been subject to disease or trauma. The SLR-PLUS STEM, a revision component, is also available to replace previously failed femoral hip arthroplasties. Both components can be used with or without cement. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. The UNI Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head. The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute). These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. Smith & Nephew Patient Matched Femoral Stem Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Patient Matched Hip Systems and their cleared Indications for Use. Smith & Nephew Patient Matched Hip Stems 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; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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. Smith & Nephew Femoral Head Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use. Smith & Nephew Hip Systems are indicated for use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew PLUS Femoral Head Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use. Smith & Nephew PLUS Hip Systems are indicated for: The PLUS Fracture Head Prosthesis is intended for use in fractures of the femoral neck and fractures or avascular necrosis of the femoral head with all Plus hip stem prostheses, which have the appropriate 12/14 Morse Taper. The INTRAPLANT Ceramic Head Prostheses is intended for use in total hip arthroplasty. The indications for use of the total hip replacement prosthesis include: degenerative joint disease including the osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedure where previous treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. The INTRAPLANT Ceramic Head Prostheses are to be used only with SL-PLUS and SLR-PLUS hip stems. Smith & Nephew Hemi-Arthroplasty Only Femoral Head Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hemi-Arthroplasty Hip Systems and their cleared Indications for Use. Smith & Nephew Hemi-Arthroplasty Hip Systems are indicated for: noninflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis rheumatoid arthritis arthritis secondary to a variety of diseases anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis revision procedures where other treatments have failed treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement The modular femoral heads are for single use only and are intended to be used as part of a hemihip replacement system when articulating against the natural acetabulum. Smith & Nephew Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use. Smith & Nephew Hip Systems are indicated for use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew PLUS Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PLUS Hip Systems and their cleared Indications for Use. Smith & Nephew PLUS Hip Systems are indicated for: The PLUS-FIT Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions. In normal cases, however, the surgeon will use an acetabular implant one size larger and in exceptional cases two sizes larger. The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring. The BICON-PLUS Acetabular Components are intended for use in primary and revision total hip arthroplasty where the acetabular socket needs restructuring. The BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty. The POLARCUP® Dual Mobility System is indicated for: All forms of osteoarthritis; dislocation risks; progressive loss of function of the hip joint as a result of a degenerative posttraumatic; or inflammatory / rheumatic destruction of the joint; femoral head necrosis; proximal femoral fractures (especially femoral neck); status following earlier operations such as osteosynthesis, intertrochanteric osteotomies, arthrodesis or failed joint replacement. The POLARCUP® Dual Mobility System is intended for cemented or press-fit application with or without flanges and pegs for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. Smith & Nephew Constrained Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Constrained Hip Systems and their cleared Indications for Use. Smith & Nephew Constrained Hip Systems are indicated for: The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is 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. Smith & Nephew Patient Specific Acetabular Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Patient Specific Hip Systems and their cleared Indications for Use. Smith & Nephew Patient Specific Hip Systems are indicated for: The Patient Specific Acetabular Reconstruction Prosthesis is intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application. The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or Girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capital epiphysis, fused hip and diastrophic variant. Smith & Nephew Hip Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Hip Systems and their cleared Indications for Use. Smith & Nephew Hip Systems are indicated for use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Accord Cable System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Accord Cable Systems and their cleared Indications for Use. The Accord Cable System is indicated for: Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below: Primary total hip arthroplasty Revision total hip arthroplasty Any procedure using anterolateral or lateral approaches Smith & Nephew Contour HA Coated Reconstruction Ring Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Contour Systems and their cleared Indications for Use. The Smith & Nephew Contour System is indicated for use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Acetabular reinforcement and reconstruction rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed previously. The device is intended for single use. Smith & Nephew Orthopaedic Cabling System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Orthopaedic Cabling System and their cleared Indications for Use. The Orthopaedic Cabling System is indicated for: General orthopaedic repair procedures including patella fractures, general cerclage, trochanteric reattachment, femur and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing fixation techniques. Trochanteric reattachment whenever the trochanter is osteotomized in any of the procedures listed below: Primary total hip arthroplasty. Revision total hip arthroplasty. Any procedure using anterolateral or lateral approaches. Smith & Nephew Reflection Acetabular Reinforcement Ring Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Reflection Acetabular Systems and their cleared Indications for Use. Smith & Nephew Reflection Acetabular Systems are indicated for: rheumatoid arthritis avascular necrosis femoral neck fractures osteomyelitis fracture-dislocation of the hip unsuccessful cup arthroplasty endoprosthesis femoral osteoarthritis traumatic arthritis slipped capital epiphysis fused hip diastrophic variant Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed previously. The device is for single use. Source page: https://510kreport.com/device/K123598 Methodology: https://510kreport.com/methodology