← Product Code [MEH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH) · K970337 # HA GLOBAL TAPER (GT) TAPERED HIP STEM (K970337) _Smith & Nephew, Inc., Orthopaedic Div. · MEH · Feb 28, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH/K970337 ## Device Facts - **Applicant:** Smith & Nephew, Inc., Orthopaedic Div. - **Product Code:** [MEH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH.md) - **Decision Date:** Feb 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3353 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The components are indicated for uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for 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. Indications also include 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; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. ## Device Story HA Global Taper (GT) Tapered Hip Stem; metal alloy femoral component; intended for uncemented fixation in primary/revision hip arthroplasty. Device replaces damaged hip joint structures; restores function in patients with degenerative joint disease, fractures, or deformities. Used in surgical settings by orthopedic surgeons. Output is physical structural support for hip joint. Benefits include rehabilitation of hip function and correction of skeletal deformities. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Metal alloy construction; tapered hip stem geometry; designed for uncemented (cementless) fixation; single-use device. ## Regulatory Identification A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Exhibit 6 K970337 # Summary of Safety and Effectiveness Smith & Nephew Orthopaedics FEB 28 1997 ## HA Global Taper (GT) Tapered Hip Stem The HA Global Taper (GT) Tapered Hip Stem is made of metal alloys. The components are indicated for uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for 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. Indications also include 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; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The devices are for single use. Cementless fixation is available with these devices. The components have the same function as other hip systems designed for cementless fixation. Analysis results were acceptable and the components should perform as well as other hip systems. CONFIDENTIAL page 14 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH/K970337](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MEH/K970337) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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