# K132435: Smith & Nephew Global Femoral Head Trials

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 22, 2013 after 78 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: 9 generations back to K911686 (1991). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113039: Smith & Nephew Radiopaque Trial Necks, Smith & Nephew, Inc. (2012) Summary page 3.

## 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, femora[ 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; avascutar necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyetitis 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 SL-PLUS Stem Primary isintended for treating patients who are candidates for total hip arlhroplasty because the natural femoral head and neck has been subject to disease or trauma. 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 SLR-PLUS STEM, a revision component, isalso available to replace previously failed femoral him 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 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. * The SL-PLUS MIA Stem isindicated for indivduals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as aresult of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composhie diagnoses 'of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. * The POLARSTEM Standard and Lateral Femoral Stems are indicated for: advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis. hemiarthroplasty. surface replacement arthroplasty, or total hip replacement, all forms of osteoarlhritis, patients with hips at risk of dislocation, and femoral neck fracture or proximal fracture to hip joint.

Source page: https://510kreport.com/device/K132435
Methodology: https://510kreport.com/methodology