S-ROM HIP SYSTEM - LOCKING PLUG

K963206 · Johnson & Johnson Professionals, Inc. · JDI · Oct 17, 1996 · Orthopedic

Device Facts

• Record ID: K963206
• Device Name: S-ROM HIP SYSTEM - LOCKING PLUG
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S-ROM Hip System - Locking Plug has the same indications for use as the S-ROM Hip System - Locking Pin. They are both indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from: 1. rheumatoid arthritis, 2. osteoarthritis, 3. post-traumatic arthritis, 4. collagen disorders, 5. avascular necrosis, and 6. nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with: 7. congenital hip dysplasia, 8. protrusio acetabuli, 9. slipped capital femoral epiphysis, 10. and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Device Story

S-ROM Hip System - Locking Plug is a component for total hip replacement systems; functions as a mechanical locking mechanism to secure shell/liner assembly. Device features cylindrical body with external lip and head with external serrations/barbs; internal threading allows attachment to insertion tool. Available in 3.5 mm and 5.0 mm sizes. Used by orthopedic surgeons in clinical/OR settings during hip arthroplasty or revision procedures. Provides mechanical stability to the hip prosthesis, preventing disengagement of components; benefits patient by maintaining structural integrity of the reconstructed hip joint.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Ti-6Al-4V Titanium Alloy. Form factor: Cylindrical body with head (internal threading, external serrations/barbs). Sizes: 3.5 mm and 5.0 mm. Mechanical locking principle via serrations and lip to resist disengagement. Sterilization: Same as predicate.

Indications for Use

Indicated for total hip replacement in patients with severe pain/disability due to structural hip joint damage from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, or femoral fracture nonunion. Also indicated for revision hip arthroplasty and patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or disability from previous fusion with inadequate bone stock.

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

• Locking Pin (K870271)
• Locking Pin (K924492)

Submission Summary (Full Text)

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OCT 17 1996
K963206

# Summary of Safety and Effectiveness Data for the S-ROM Hip System - Locking Plug

Johnson & Johnson Professional, Inc.
325 Paramount Drive
Raynham, MA 02767-0350

## Contact Person

Jennifer L. Morse
Associate Regulatory Affairs Specialist
Phone: [phone]
Fax: [phone]

## Name of Device

Proprietary Name: S-ROM Hip System - Locking Plug
Common Name: Locking Plug
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis
Regulatory Class: Class II by 21 CFR § 888.3350
Product Code No.: 87JDI
Owner/Operator No.: 9001269

## Device Classification

This device has been placed in Class II for Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR § 888.3350.

## Statement of Substantial Equivalence

The S-ROM Hip System - Locking Plug is substantially equivalent to the Locking Pin currently marketed in the United States under both #K870271 and K924492.

The subject device is composed of the same material as the Locking Pin (Ti-6Al-4V Titanium Alloy). Further, the intended use, design, and manufacture of the Locking Plug are substantially equivalent to the currently distributed Locking Pin. Additionally, the packaging and method of sterilization utilized for the Locking Plug are the same as those used for the Locking Pin.

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Indications for Use

The S-ROM Hip System - Locking Plug has the same indications for use as the S-ROM Hip System - Locking Pin. They are both indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from:

1. rheumatoid arthritis,
2. osteoarthritis,
3. post-traumatic arthritis,
4. collagen disorders,
5. avascular necrosis, and
6. nonunion of femoral fractures.

Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with:

7. congenital hip dysplasia,
8. protrusio acetabuli,
9. slipped capital femoral epiphysis,
10. and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

## Physical Description

The Locking Plug consists of a head and body. The head has both internal threading and external serrations (barbs). The internal threading allows attachment of the insertion tool to the Locking Plug. The body is cylindrical with an external lip. Both the external serrations of the head and the lip of the Locking Plug body aid in resisting disengagement of the Locking Plug from the shell/liner assembly. The Locking Plug is available in both 3.5 mm and 5.0 mm sizes.