NATURAL HIP SYSTEM - DRG HIP STEM

K961799 · Intermedics Orthopedics · JDI · Jul 15, 1996 · Orthopedic

Device Facts

• Record ID: K961799
• Device Name: NATURAL HIP SYSTEM - DRG HIP STEM
• Applicant: Intermedics Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: Jul 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

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 (IJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3. Revision of previously failed arthroplasty.

Device Story

Femoral component for total hip arthroplasty; replaces femoral anatomy. Features widened proximal geometry for metaphyseal fit; grit-blasted surface for bone/cement interdigitation; optional proximal collar for cement pressurization; distal centralizer hole. Used in cemented or cementless (press-fit) procedures. Operated by orthopedic surgeons in clinical/OR settings. Provides structural support for hip joint; reduces interface stress; improves fixation. Benefits patients by restoring joint function and reducing pain.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Wrought or Forged CoCr. Design: Proximal wedge-shaped, optional proximal collar, grit-blasted surface below collar, distal centralizer hole. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with inflammatory degenerative joint disease (avascular necrosis, osteoarthritis), inflammatory joint disease (rheumatoid arthritis), failed previous surgery with persistent pain/deformity/dysfunction, or revision of failed arthroplasty requiring total hip replacement.

Regulatory Classification

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).

Predicate Devices

• Premier Total Hip Stem (K894051)
• Osteonics ODC Cemented Hip Stem
• Osteonics ODC Hip Stem
• Perfecta IMC Stem

Submission Summary (Full Text)

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JUL 2 96 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
FAX NO. 5128736291
P. 05

JUL 15 1996
K961799
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.: [phone]
Fax: [phone]

Contact Person:
Regarding this submission:
Name: Sam Mirza
Tel.: [phone]
Fax: [phone]

Official Correspondent
Name: Jacquelyn Hughes
Tel.: [phone]
Fax.: [phone]

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).

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JUL-296 10000000000000000000000000000000000000000000000000000

FAX NO. 5128736291

P. 06

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

## 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 total hip arthroplasty. The DRG Hip stem employs a widened or expanded proximal geometry 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).

## 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 (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
3. Revision of previously failed arthroplasty.

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JUL-2-36 11:30 FAX NO. 5128736291 P.07

# 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.

| Characteristics | Subject Device
DRG Hip Stem | Predicate Devices | | | |
| --- | --- | --- | --- | --- | --- |
| | | 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 |