BURCH/SCHNEIDER REINFORCEMENT CAGE

K960678 · Intermedics Orthopedics · JDI · May 3, 1996 · Orthopedic

Device Facts

• Record ID: K960678
• Device Name: BURCH/SCHNEIDER REINFORCEMENT CAGE
• Applicant: Intermedics Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: May 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Burch/Schneider Reinforcement Cage is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Burch/Schneider Reinforcement Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application. Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery. The general indications associated with the use of Burch/Schneider Reinforcement Cage in total hip arthroplasty include: 1. Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis, 2. Fracture or avascular necrosis of the femoral head, 3. Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

Device Story

Burch/Schneider Reinforcement Cage is an acetabular reinforcement device used in total hip arthroplasty. It bridges acetabular bone loss and supports all-polyethylene acetabular implants in cemented applications. The device features a dome with a central hole, superior and inferior flanges with screwholes for optional ilium/ischium attachment. It is implanted by orthopedic surgeons during hip reconstruction procedures. The device provides structural support to the acetabulum, facilitating stable fixation of the prosthetic hip components in patients with compromised bone stock.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Stainless steel (AISI 316L) or commercially pure Titanium (ISO 5832-2). Design: Dome with central hole, superior and inferior flanges with screwholes. Thickness: 2.0mm. Application: Cemented. Sterilization: Provided sterile.

Indications for Use

Indicated for patients with acetabular bone deficiency requiring acetabular reinforcement during total hip arthroplasty. Applicable for conditions including acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, post-fracture defects, acetabular loosening, tumors, revision surgery, advanced joint destruction (degenerative, posttraumatic, or rheumatoid arthritis), femoral head fracture/avascular necrosis, and failed previous hip surgeries.

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

• H.B. Burch Anti-Protrusio Reinforcement cage (Preamendment)
• Acetabular Roof Reinforcement Ring (K953578)
• Anti-Protrusio Reinforcement cage (Depuy Inc.)

Submission Summary (Full Text)

{0}

K960678

MAY - 3 1996

# 510(k) Premarket Notification
## Summary of Safety and Effectiveness for
## Burch/Schneider Reinforcement Cage

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 Burch/Schneider Reinforcement Cage.

### Submitter:

Intermedics Orthopedics, Inc.
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:

February 15, 1996

### Proprietary name

Burch/Schneider Reinforcement Cage

### Common Name:

Acetabular reinforcement cage

### Classification name:

Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (21CFR 888.3350). Class 2

### Predicate Devices:

The features employed by Burch/Schneider Reinforcement Cage are substantially equivalent to the features employed by the following predicate legally marketed devices:

- **Preamendment H.B. Burch Anti-Protrusio Reinforcement cage: Sulzer Orthopedics Limited (Preamendment Status)**
- Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578)
- Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI).

### Device Description:

The Burch/Schneider Reinforcement Cage is a modified version of the preamendment H.B. Burch Anti-Protrusio Reinforcement Cage, manufactured by Protek AG (now consolidated into Sulzer

Burch/Schneider Reinforcement Cage
Summary of Safety and Effectiveness
Page SSE1

{1}

Orthopedics Limited), that has been in commercial distribution in the United States prior to 1976.

The Burch/Schneider Reinforcement Cage will be manufactured from either stainless steel (AISI 316L) or commercially pure (CP) Titanium (International Organization for Standards (ISO) 5832-2). The design of the Burch/Schneider Reinforcement Cage include the following:

- a dome area with a dome hole and screwholes,
- a superior flange employing screwholes for the optional attachment to the ilium,
- an inferior flange employing screwholes for the optional attachment to the ischium,
- available in thickness of 2.0 (+0.0, -0.3)mm

## Intended Use:

The Burch/Schneider Reinforcement Cage is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Burch/Schneider Reinforcement Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application.

Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.

The general indications associated with the use of Burch/Schneider Reinforcement Cage in total hip arthroplasty include:

1. Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis,
2. Fracture or avascular necrosis of the femoral head,
3. Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.

## Summary of Technological Characteristics:

Substantial equivalence determination for the Burch/Schneider Reinforcement Cage is based upon the comparison of the subject device to the following legally marketed predicate Sulzer Orthopedics Limited and competitive devices:

- Preamendment H.B. Burch Anti-Protrusio Reinforcement Cage: Sulzer Orthopedics Limited (Preamendment Status)

Burch/Schneider Reinforcement Cage
Summary of Safety and Effectiveness
Page SSE2

{2}

- Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578)
- Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI)

The characteristics of the Burch/Schneider Reinforcement Cage, either alone or in combination, are substantially equivalent to the aforementioned predicate devices in terms of materials, intended use, and design characteristics. A side by side tabular comparison of the characteristics of the Burch/Schneider Reinforcement Cage to those of the predicate devices follows:

| Characteristics | Subject Device
Burch/Schneider Reinforcement Cage | Predicate Devices | | |
| --- | --- | --- | --- | --- |
| | | H.B. Burch
Anti-Protrusio Reinforcement Cage | Anti-Protrusio Reinforcement Cage | Acetabular Roof Reinforcement Ring |
| Manufacturer | Sulzer Orthopedics Limited | Sulzer Orthopedics Limited | Depuy Inc. | Sulzer Orthopedics Limited |
| 510(k) No. | - | Preamendment | Unknown to IOI | K953578 |
| Application | Cemented | Cemented | Cemented | Cemented |
| Material | Stainless Steel or CP Titanium | Stainless Steel | Stainless Steel | CP Titanium |
| Superior Flange | Yes | Yes | Yes | No |
| Inferior Flange | Yes | Yes | Yes | No |
| Screwholes | Yes | Yes | Yes | Yes |
| Sterile | Yes | No | Unknown to IOI | Yes |
| Sizes | 44 and 50mm Left/Right | 44 and 50mm Left/Right | 44 and 50mm Left/Right | Diameters 36 - 58mm (2mm Increments) |

Burch/Schneider Reinforcement Cage
Summary of Safety and Effectiveness
Page SSE3