# K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 21, 2024 after 214 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K810258 (1981). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 179 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 8.
- K970351: Global Taper Spectron Hip Stems, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 8.
- K963509: Global Taper Tapered Hip System, GT Spectron, Smith & Nephew Richards, Inc. (1997) Summary page 8.
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009) Summary page 8.
- K113848: R3 Xlpe Liners, Smith & Nephew, Inc. (2012) Summary page 8.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 8.
- K963486: Revision Hip System, Smith & Nephew Richards, Inc. (1996) Summary page 8.
- K211176: Smith & Nephew Hip Systems, Smith & Nephew, Inc. (2022) Summary page 8.
- K081124: MDF Revision Hip System, Smith & Nephew, Inc. (2008) Summary page 8.
- K831884: Spectron Extra-Small, Straight Femoral, Richards Manufacturer Co. (1983) Summary page 8.
- K823722: Spectron Long, Straight Femoral Prosthes, Richard'S Medical Equip., Inc. (1983) Summary page 8.
- K990369: Synergy Cemented Hip Stem, Smith & Nephew, Inc. (1999) Summary page 8.
- K991485: Synergy Porous Size 8 Hip Stem, Smith & Nephew, Inc. (1999) Summary page 8.
- K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002) Summary page 8.

## Indications for use
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. Total hip systems may be indicated for use (i) with bone cement, (ii) without bone cement, or (iii) for use with or without bone cement. Refer to the product labeling and literature for specific applications. Some of the diagnoses listed above may increase risk of complications and reduce the chance of a satisfactory result. Specifically, an increased risk of complications for revision surgery for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level can negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a high likelihood of revision in younger, heavier, or more active patients. Specifically, the risk of complications is greater in obese and morbidly obese patients. The Anthology Hip System, CPCS Cemented Hip System, and Synergy Hip System are for primary surgeries only. The TANDEM Unipolar and Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture. Acetabular 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 degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip. The Constrained Liners are indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options to constrained acetabular components have been considered. Some of the diagnoses listed above are associated with an increased risk of complications and reduced chance of a satisfactory short- and long-term outcomes. Specifically, an increased risk of complications to revision surgeries for any reason has been documented in the literature. Patient selection factors such as age, weight, and activity level may negatively affect implant longevity and increase the risk of revision surgery. Literature has shown a higher likelihood of revision in younger, heavier and/or more active patients. Specifically, the risk of complications is higher in obese patients.

Source page: https://510kreport.com/device/K240783
Methodology: https://510kreport.com/methodology