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K Number
K980794
Device Name
DUAL LOCK HIP STEM
Manufacturer
DEPUY, INC.
Date Cleared
1998-05-20

(79 days)

Product Code
JDI
Regulation Number
888.3350
Type
Traditional
Panel
OR
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Dual Lock Hip Stem is indicated for use as the cemented femoral component in total hip arthroplasty for the treatment of:

  1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
  2. Avascular necrosis of the femoral head;
  3. Acute traumatic fracture of the femoral head or neck;
  4. Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement;
  5. Certain cases of ankylosis.
Device Description

The Dual Lock Hip Stem system consists of variously sized femoral hip stems made from Cobalt Chrome which will be available with standard and lateral offsets. The Dual Lock Hip Stems are designed with neck tapers intended to be used with DePuy femoral ball heads made from Cobalt Chrome or Zirconia Ceramic, and DePuy acetabular components with ultra high molecular weight polyethylene articulating surfaces.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study that proves the device meets such criteria. The document is a 510(k) summary for the Dual Lock® Hip Stem, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

The content mainly covers:

  • Device identification: Trade name, common name, classification, product code.
  • Device description and intended use: Materials, design features, and medical conditions for which it is indicated.
  • Basis of substantial equivalence: Comparison of materials, design, sizing, and intended use with predicate devices (DePuy Porocoat Dual Lock Total Hip System, DePuy Prodigy Hip, and DePuy Cemented Hip Prosthesis). The statement "It is expected that the performance of the subject DePuy Dual Lock Hip Stem will be similar to these predicate devices" is made, but no specific performance metrics or studies are detailed to support this expectation.
  • FDA clearance letter: A letter confirming the substantial equivalence determination but not detailing performance studies.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth details, or training set information. This type of detailed performance data is typically not included in a 510(k) summary, which primarily serves to establish equivalence to legally marketed devices.

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.