EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP

K994146 · Plus Orthopedics · LWJ · Dec 11, 2000 · Orthopedic

Device Facts

• Record ID: K994146
• Device Name: EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
• Applicant: Plus Orthopedics
• Product Code: LWJ · Orthopedic
• Decision Date: Dec 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EPF®-PLUS Cementless Press-Fit Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions.

Device Story

EPF®-PLUS Cementless Press-Fit Acetabular Cup is a titanium orthopedic implant used in hip replacement or revision surgery. Device is a press-fit cup designed to replace the acetabulum; provides structural support for hip joint. Used by orthopedic surgeons in operating room settings. Implant is made of commercially pure titanium with a flame-sprayed plasma surface treatment to enhance bone apposition. Device is supplied sterile for single use. Surgeon implants cup into prepared acetabulum to restore joint function and alleviate pain associated with arthrosis or previous hip trauma. Benefits include improved joint stability and mobility for patients requiring hip reconstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Acetabular cup made of commercially pure titanium. Materials conform to ASTM F-136-98, ASTM F 67-95 (gr. 4), F 639-93, ISO 5832-2, and ISO 5834-1 & -2. Features flame-sprayed plasma surface treatment. Supplied sterile; terminal sterilization process used.

Indications for Use

Indicated for patients with advanced hip joint destruction due to degenerative, post-traumatic, or rheumatoid arthritis, femoral head fracture or avascular necrosis, or sequelae from prior hip surgeries (e.g., internal fixation, arthrodesis, hemiarthroplasty, total hip replacement). Also indicated for acetabular revisions.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• PLUS EPF Acetabular Cup (K972931)

Submission Summary (Full Text)

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# Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

#### 1. Device Name:

EPF®-PLUS Cementless Press-Fit Acetabular Cup Trade Name:

Common Name: Acetabular cup

Classification Name:

PROSTHESIS. HIP. SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

## 2. Establishment Name & Registration Number:

Plus Orthopedics Name:

Number: 2086141

#### 3. Classification:

No Code Section Reference Available.

Device Class: Class II

Classification Panel: Orthopaedic and Rehabilitation Devices Panel

Product Code: 87LWJ

## 4. Special Controls:

As a Class II medical device, guidance documents and special controls are in effect.

#### Equivalent Legally Marketed Device(s): 5.

- PLUS EPF Acetabular Cup, Plus Orthopedics, K972931 .
The EPF -PLUS Cementless Press-Fit Acetabular Cup is substantially equivalent as a result of the use of identical materials, identical indications for use and patient population, identical size offerings, identical instrumentation, identical production facilities and identical sterifization method. The only difference between the original and the modified device is the application of a flame sprayed plasma surface treatment. The characteristics of the surface treatment are not new and are commonly found on many similar orthopaedic implant devices.

#### 6. Device Description:

The EPF®-PLUS Cementless Press-Fit Acetabular Cup is a surface treated titanium acetabular cup made from commercially pure titanium. The materials conform to national standards including ASTM F-136-98, ASTM F 67-95, gr. 4, F 639-93, ISO 5832-2. & ISO 5834-1 & -2.

#### Indications for Use:

"The EPF®-PLUS Cementless Press-Fit Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-fraumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions."

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#### 7. Applicant Name & Address:

PLUS ORTHOPEDIC 3550 General Atomics Court Building # 15-100 San Diego, CA 92121 858.455.2400 tel - 858.455.2424 fax

#### 8. Company Contact:

Mr. Hartmut Loch Plus ORTHOPEDIC 3550 General Atomics Court Building # 15-100 San Diego, CA 92121 858.455.2400 tel - 858.455.2424 fax

## 9. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94553-3389 925.356.2640 vox 925.356.2654 fax

#### 10. Special Guidance Document Information:

Special Guidance documents are in effect for this device, including:

- Premarket Notification [510(k)] Applications for Orthopaedic Devices. .
- Document for Testing Orthopaedic Implants With Modified Metallic Surfaces Apposing Bone or . Bone Cement.

#### 11. Storage, Packaging & Sterilization Information:

The EPF®-PLUS Cementless Press-Fit Acetabular Cups are supplied sterile. All implants are individually packaged & labeled and supplied in boxes for ease in shipping and storage. All packaging should be inspected on arrival for evidence of shipping damage. Any product for use in the operating room must be processed, opened, handled and placed into use following accepted operating room sterile technique. The product is terminally sterilized by an appropriate sterilization process exposure. Sterility Assurance Level (SAL) is at least 100. Once opened, the product must be used or discarded. No attempt should be made at resterilization.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 11 2000

PLUS Orthopedics c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K994146

EPF®-PLUS Cementless Press-Fit Acetabular Cup Product Code: LWJ, LZO Regulatory Class: II Dated: October 7, 2000 Received: October 17, 2000

# Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Section 510(x) notifically equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stated in the elief to devices manotents, or to devices that have been that have been the Your move enactment date of the Medical Dorted Finesal. Food, Drug, and Cosmetic Act (Act). TYou may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions or the receive 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 (1 icharter Approval), it they be of Federal Regulations, Title 21, Parts 800 to 895. arrouning your at not rive slent determination assumes compliance with the current Good A substantiany equirement, 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 inspections, the Food and Drig Frankers action. In addition, FDA may publish comply with the Grill Tegatation 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.

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.

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## Page 2 - Mr. David W. Schlerf

If you desire specific advice for your device on our labeling regulation (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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark McMellerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K994146 510(k) Number:

Device Name(s):

# EPF®-PLUS Cementless Press-Fit Acetabular Cup

## Intended Use:

"The EPF®-PLUS Cementless Press-Fit Acetabular Cup is intended for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, post-traumatic or rheumatoid arthritis, fracture or avascular necrosis of the femoral head, sequelae of previous operations, such as internal fixation, joint reconstruction, arthrodesis, hemiarthroplasty or total hip replacement. The same considerations apply to acetabular revisions."

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Melkerson

(Division Sign-Off) (Division Sign Ora)
Division of General Restorative D 510(k) Number .

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional format 1-2-96)