MPF ACETABULAR CUP

K011836 · Plus Orthopedics · LZO · Sep 7, 2001 · Orthopedic

Device Facts

• Record ID: K011836
• Device Name: MPF ACETABULAR CUP
• Applicant: Plus Orthopedics
• Product Code: LZO · Orthopedic
• Decision Date: Sep 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MPF Acetabular Cup is intended for uncemented use 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

MPF Acetabular Cup is a cementless, press-fit hip prosthesis component. Device consists of CP Titanium cup (ASTM F67) with Ti-Plasma coating; available in 10 sizes (46-64mm). UHMWPE inserts provided in neutral or 20° hooded versions. Optional Ti6Al4V cancellous bone inserts (20-50mm) and screw hole covers available. Used in orthopedic surgery for total hip replacement or revision. Surgeon implants device into acetabulum; functions as part of a semi-constrained hip joint system. Compatible with various PLUS and INTRAPLANT femoral stems and ball heads. Provides stable, uncemented fixation to restore hip joint function and alleviate pain associated with arthrosis or necrosis.

Clinical Evidence

Bench testing only. Biomechanical tests were performed to evaluate the structural integrity and performance of the implant. Results demonstrated that the MPF Acetabular Cup is equivalent to similar legally marketed hip implants and is sufficient for in vivo loading conditions.

Technological Characteristics

Materials: CP Titanium (ASTM F67) cup, Ti-Plasma coating, Ti6Al4V cancellous bone inserts, UHMWPE inserts. Design: Cementless, press-fit acetabular cup; 10 sizes (46-64mm in 2mm increments). Features: 3 screw holes for optional fixation; threaded screw hole covers. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring hip joint replacement due to arthrosis (degenerative, post-traumatic, or rheumatoid arthritis), femoral head fracture, avascular necrosis, or sequelae of prior hip surgeries (internal fixation, reconstruction, arthrodesis, hemiarthroplasty, or total hip replacement). Applicable for primary and revision acetabular procedures.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• LPC-PLUS Acetabular Cup (K003274)

Reference Devices

• CS-PLUS Stem with CoCrMo Ball Head (K936214)
• SL/SLR-PLUS Stem with CoCrMo Ball Head (K932481)
• SL/SLR-PLUS Stem with Biolox Ceramic Head (K930963)
• INTRAPLANT Ceramic Ball Heads (K990261)
• MODULAR-PLUS Revision Stem (K994126)
• PLUS CoCrMo Ball Heads (K001942)

Submission Summary (Full Text)

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KD11836

## SEP - 7 2001

### 510(k) Summary of Safety and Effectiveness

[in accordance with SMDA of 1990, 21 CFR 807.92(c)]

Contact:

PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: [phone] – Fax: [phone] Attn: Mr. Hartmut Loch, RAC Director, Regulatory Affairs

Trade name:

Classification

name:

MPF Acetabular Cup

Acetabular Cup Common name:

> Hip joint metal/polymer semi-constrained uncemented prosthesis. & 888.3353, Class II, Orthopedic Device Panel 87

LZO & LWJ Product Code:

Device Description and Characteristics: The MPF Acetabular Cup is a cementless, press-fit cup. It is available in 10 sizes ranging from 46 mm to 64 mm in 2 mm increments. It is Sizos Tanging Trom CP Titanium according to ASTM F 67. UHMWPE inserts are available in neutral and 20° hooded versions. Cancellous bone inforts are a from Ti6Al4V are available in 7 sizes ranging from 20 mm to 50 mm in length. They have a standard 6.5 mm thread diameter and 3.5 00 mm in long.m The cup has 3 screw holes for optional min octagonal ocrantion. The open, unused screw holes can be closed with threaded screw hole covers. The MPF cup may be used with the following ball heads manufactured by PLUS and INTRAPLANT that are cleared for marketing by the U.S. FDA: CS-PLUS® Stem with CoCrMo Ball Head (K936214 - 6/15/94) SL/SLR-PLUS® Stem with CoCrMo Ball Head (K932481 - 6/8/94) SL/SLR-PLUS® Stem with Biolox Ceramic Head (K930963 - 17794) INTRAPLANT Ceramic Ball Heads (K990261 - 8/27/99) MODULAR-PLUS® Revision Stem (K994126 - 5/4/00) PLUS CoCrMo Ball Heads (K001942 - 7/25/00)

- The MPF Acetabular Cup is substantially equivalent to the LPC-PLUS Equivalence: Acetabular Cup (K003274 - S/E 4/6/2001). Both cups are similar in design. They both are manufactured from CP Titanium conforming to ASTM F67 and are Ti-Plasma coated. In addition, both cups are for uncemented use and are intended for the same medical indications.
The MPF Acetabular Cup is intended for uncemented use for all types of Indications: 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.

Biomechanical tests have been performed. The test results were equivalent Performance data: to other similar implants and are sufficient for in vivo loading.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.

SEP - 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Helmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121

Re: K011836

Trade/Device Name: MPF Acetabular Cup Regulation Number: 888.3353 Regulation Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Regulatory Class: II Product Code: LZO, LWJ Dated: June 8, 2001 Received: June 12, 2001

Dear Mr. Loch:

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 legally marketed predicate devices marketed in interstate commerce beated in the enormers of the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls orovisions of the Act. The general controls provisions 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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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Page 2 - Mr. Helmut Loch, 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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sasa Wal, N

Image /page/2/Picture/5 description: The image contains a handwritten letter 'k' in a simple, cursive style. The letter is drawn with a single stroke for the vertical line and a connected, curved stroke for the angled lines that form the rest of the letter. The letter appears to be written with a pen or marker, and the lines are smooth and consistent.

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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# 510(k) Number: KØ11836

### Device Name(s):

MPF ACETABULAR CUP

#### Indications for Use:

The MPF Acetabular Cup is intended for uncemented use for all types of arthrosis, such as advanced destruction of the hip joint due to degenerative, annous, and 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)

Sll

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

Prescription Use

510(k) Number `/1011834`

OR Over-The-Counter-Use

(Per 21 CFR 801.109)

(Optional format 1-2-96)