SUMMIT ACETABULAR SYSTEM

K983014 · Johnson & Johnson Professionals, Inc. · LPH · Oct 27, 1998 · Orthopedic

Device Facts

• Record ID: K983014
• Device Name: SUMMIT ACETABULAR SYSTEM
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Oct 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.

Device Story

SUMMIT™ Acetabular System is a modular hip replacement component; consists of titanium alloy (Ti-6Al-4V) outer shell with commercially pure titanium porous coating and UHMWPE liner. Shells available in various configurations (No-Hole, Cluster Hole, Multi-Hole, Spiked, Deep Profile) to accommodate different femoral head sizes and face angles. Includes apical hole plug and titanium alloy bone screws. Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Device provides stable acetabular interface for femoral head articulation; restores joint function; reduces pain; improves patient mobility.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular acetabular cup system. Materials: Titanium alloy (Ti-6Al-4V) shell, commercially pure titanium porous coating, UHMWPE liner. Standards: ASTM F-67, ASTM F136, ASTM F1044. Configurations: No-Hole, Cluster Hole, Multi-Hole, Spiked, Deep Profile. Femoral head compatibility: 22.225, 26, 28, 32mm. Face angles: 0°, 10°, 15°. Cementless application.

Indications for Use

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

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• ZTT™ I and II Acetabular Cup (K951000)
• Arthopor™ I and II (K955511)
• PFC™ Acetabular Cup (K931189 and K930712)
• DePuy DURALOC® 300 Series (K951301)

Submission Summary (Full Text)

{0}------------------------------------------------

# Exhibit I

# 510(k) Summary SUMMIT™ Acetabular System

K98 3014

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

#### A. Contact Person:

Janet G. Johnson, RAC Associate Regulatory Affairs Specialist [phone]

#### B. Device Information:

| Proprietary Name: | SUMMIT™ Acetabular System |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Acetabular Cup and Liner |
| Classification Name: | Hip joint metal/ polymer semi-constrained porous-<br>coated uncemented prosthesis |
| Regulatory Class: | Class II, per 21 §CFR 888.3358 |
| Product Code: | 87 LPH |

#### C. Indications for Use:

The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.

{1}------------------------------------------------

## D. Device Description:

The SUMMIT™ Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, an outer shell composed of titanium alloy (Ti-6Al-4V) with a commercially pure titanium porous coating and a liner of ultrahigh molecular weight polyethylene (UHMWPE), which locks into the outer shell. The acetabular component articulates with a femoral head of an appropriate diameter.

The acetabular shell has a porous-coated surface and is provided No-Hole, Cluster Hole, Multi-Hole, Spiked and Deep Profile configurations that accept liners for 22.225, 26, 28 and 32mm femoral head sizes; as well as 0°, 10°, and 15° face angles.

Also available for use with the SUMMIT™ Acetabular System are an apical hole plug and a variety of bone screws, all composed of titanium alloy.

## E. Substantial Equivalence:

The SUMMIT™ Acetabular System is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the ZTT™ I and II Acetabular Cup (K951000), Arthopor™ I and II (K955511), PFC ™ Acetabular Cup (K931189 and K930712) and the DePuy DURALOC ® 300 Series (K951301).

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ASTM F-67, ASTM F136 and ASTM F1044.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1998

Janet G. Johnson, RAC Associate Requlatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K983014 Summit™ Acetabular System Trade Name: Regulatory Class: II Product Code: LPH Dated: August 27, 1998 Received: August 28, 1998

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Janet G. Johnson, RAC

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) Device Name

SUMMIT™ Acetabular System

## Indications For Use

The SUMMIT™ Acetabular System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

All SUMMIT™ porous -coated acetabular shells are indicated for cementless application.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <i>Yes</i> |
|-----------------------|------------|
| (Per 21 CFR §801.109) | |

OR

| Over-the-Counter Use | <i>No</i> |
|----------------------|--------------------------|
| | (Optional Format 1-2-96) |

(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | K983014 |
|---------------|---------|
|---------------|---------|