K Number
K961799
Device Name
NATURAL HIP SYSTEM - DRG HIP STEM
Date Cleared
1996-07-15

(67 days)

Product Code
Regulation Number
888.3350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty. The general indications associated with the use of DRG Stem in total hip arthroplasty include: - 1. Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis. - ni Those patients with failed previous surgery where pain, deformity or dysfunction persists. - র প Revision of previously failed arthroplasty.
Device Description
The DRG Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented toral hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometty for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown. Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface. The distal portion of DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA).
More Information

No
The device description and intended use are purely mechanical, describing a hip stem implant with no mention of software, algorithms, or data processing.

Yes

The device, a hip stem, is intended to replace anatomy of the femur and is used in cases of total hip replacement to address inflammatory degenerative joint diseases. This directly falls under the definition of a therapeutic device as it treats a medical condition.

No

Explanation: The device is a hip stem intended for human implantation as a replacement for the anatomy of the femur; it is not used to diagnose a medical condition.

No

The device description clearly details a physical hip stem implant made of metal, intended for surgical implantation. It describes material properties, geometry, and features for fixation, which are all hardware components.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description: The description clearly states that the DRG Hip Stem is a physical implant intended to replace the anatomy of the femur. It is a surgical device, not a diagnostic test.
  • Intended Use: The intended use is for total hip replacement and revision of failed arthroplasty, which are surgical procedures, not diagnostic procedures.

The device is a surgical implant used in orthopedic surgery.

N/A

Intended Use / Indications for Use

The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty .

The general indications associated with the use of DRG Stem in total hip arthroplasty include:

    1. Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
  • ni Those patients with failed previous surgery where pain, deformity or dysfunction persists.
  • র প Revision of previously failed arthroplasty.

Product codes

Not Found

Device Description

The DRG Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented toral hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometty for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown.

Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.

The distal portion of DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Femur

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K894051, Unknown, Unknown

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

11 15 1996

长961999

ಸಂಸ್ಕೃತಿಯರ ವಿಧಾರಿಸಿದೆ. ನಿರ್ವಹಿಸಿದ

510(k) Premarket Notification Summary of Safety and Effectiveness for Natural Hip System - DRG Hip Stem

In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the DRG Hip Stem.

| Submitter: | Intermedics Orthopedics, Inc. (IOI)
9900 Spectrum Drive
Austin, Texas, 78717
Tel.: (512) 432-9900
Fax: (512) 432-9291 | | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person: | Regarding this submission:
Name: Sam Mirza
Tel.: 512-432-9751
Fax: 512-432-9291 | | | | |
| | Official Correspondent
Name: Jacquelyn Hughes
Tel.: 512-432-9687
Fax.: 512-432-9291 | | | | |
| Date: | May 21, 1996 | | | | |
| Proprietary name | Natural Hip System - DRG Hip Stem | | | | |
| Common Name: | Total Hip Prosthesis - Femoral Component | | | | |
| Classification name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21CFR 888.3353). | | | | |
| Predicate Devices: | The features employed by the DRG Hip Stem are substantially
equivalent to the features employed by the following predicate legally
marketed devices: | | | | |
| | Premier Total Hip Stem: Intermedics Orthopaedics Inc.
(510(k) #K894051). Osteonics ODC Cemented Hip Stem: Osteonics Corporation
(510(k) number unknown to IOI). Osteonics ODC Hip Stem: Osteonics Corporation (510(k)
number unknown to IOI). | | | | |

1

JUL- 2-96 - 7-96 - 2 - 2 - 2 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . FAX NO. 5128736291

P. 06

Perfecta IMC Stem: Orthomet Inc. (510(k) number unknown to I()I .

The DRG Hip Stem employs a Sulzer 12/14 configured threaded Device Description: trunnion for attachment to IOI's femoral bearing heads. The DRG Hip Stem is available with or without a proximal collar. The proximal collar enhances cement pressurization in cases of cemented toral hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometty for enhanced fit of the stem in the metaphyseal canal of the femur. The widened or expanded proximal geometry of the hip stem is designed to reduce stresses that can potentially cause cement/bone or bone/prosthesis interface breakdown.

Surface enhancement via grit blasting is employed on the entire length of hip stem below the collar. Grit blasted surfaces provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surfaces provide a greater interdigitation with bone cement. In a press-fit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.

The distal portion of DRG Hip Stem employs a hole for the attachment of a distal centralizer fabricated from polymethylmethacrylate (PMMA).

The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty .

The general indications associated with the use of DRG Stem in total hip arthroplasty include:

    1. Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis.
  • ni Those patients with failed previous surgery where pain, deformity or dysfunction persists.
  • র প Revision of previously failed arthroplasty.

Intended Use:

2

Summary of Technological Characteristics:

A side by side tabular comparison of the characteristics of the DRG Hip Stem to those of the currently marketed IOI and competitive devices follows

| | Subject
Device | Predicate Devices | | | |
|---------------------------------------------|---------------------------------------------------------|------------------------------|--------------------------------------|------------------------|-------------------------|
| Characteristics | DRG
Hip Stem | Premier
Total Hip
Stem | ODC Fx
Hip Stem | ODC Hip
Stem | Perfecta
IMC
Stem |
| Manufacturer | IOI | IOI | Osteonics | Osteonics | Orthomet |
| 510(k)# | | K894051 | Unknown | Unknown | Unknown |
| Material | Wrought or
Forged CoCr | Titanium
alloy | Cast CoCr | Cast CoCr | Forged
CoCr
alloy |
| Intended Use | Cemented/
Cementless | Cemented | Cemented | Cemented | Cemented |
| Proximal wedge
shaped design | Yes | Yes | Yes | Yes | Yes |
| Proximal collar | Available
with or
without
collar | Yes | Yes | Yes | Yes |
| Surface
Enhancement
Via Grit Blasting | Entire length
below the
collar of the
hip stem | Proximal
third only | Entire length
below the
collar | Proximal third
only | Proximal
third only |
| Distal Canal
Centralizer | Yes | Yes | No | Yes | Yes |
| Neck Lengths | 25-41mm | 35mm | 25-35mm | 25-40mm | Unknown |
| Sizes | 5 sizes | 7 sizes | 5 sizes | 7 sizes | 6 sizes |