Who is the manufacturer of GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

Smith & Nephew Richards, Inc. filed the 510(k) submission for GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON (K963509).

What is the FDA product code for GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON

K963509 · Smith & Nephew Richards, Inc. · LPH · Jan 27, 1997 · Orthopedic

Device Facts

Record ID	K963509
Device Name	GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
Applicant	Smith & Nephew Richards, Inc.
Product Code	LPH · Orthopedic
Decision Date	Jan 27, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The components are indicated for cemented and 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

Global Taper (GT) Tapered Hip System comprises metal alloy hip stems and femoral heads; designed for primary or revision hip arthroplasty. Used in clinical/OR settings by orthopedic surgeons. Provides structural replacement for damaged hip joints; supports both cemented and uncemented fixation. Enables rehabilitation of hip function following trauma or degenerative disease. Single-use device.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Metal alloy hip stems and femoral heads; tapered design; supports cemented or uncemented fixation; single-use.

Indications for Use

Indicated for patients undergoing primary or revision hip surgery due to trauma, NIDJD (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), remote osteomyelitis, nonunion, femoral neck/trochanteric fractures, or deformity correction.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Related Devices

K970337 — HA GLOBAL TAPER (GT) TAPERED HIP STEM · Smith & Nephew, Inc., Orthopaedic Div. · Feb 28, 1997
K970351 — GLOBAL TAPER SPECTRON HIP STEMS · Smith & Nephew, Inc., Orthopaedic Div. · Feb 28, 1997
K963486 — REVISION HIP SYSTEM · Smith & Nephew Richards, Inc. · Nov 27, 1996
K072417 — SMITH & NEPHEW MIS HIP STEM · Smith & Nephew, Inc. · Jan 10, 2008
K052275 — SMITH & NEPHEW PLATFORM HIP STEM · Smith & Nephew, Inc. · Dec 7, 2005

Submission Summary (Full Text)

{0} JAN 27 1997 K963509 # Summary of Safety and Effectiveness ## Smith & Nephew Orthopaedics ### Global Taper Tapered Hip System The Global Taper (GT) Tapered Hip System consists of hip stems and femoral heads with a new taper. The hip stem components of the GT Tapered Hip System are made of metal alloys. The components are indicated for cemented and 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 or cement fixation is available with these devices. The components of the Tapered Hip System have the same function as other hip systems designed for cemented and cementless fixation. Analysis results were acceptable and the components of the Tapered Hip System should perform as well as other hip systems.