PE-PLUS ACETABULAR CUP

K992153 · Plus Orthopedics · JDI · Sep 23, 1999 · Orthopedic

Device Facts

• Record ID: K992153
• Device Name: PE-PLUS ACETABULAR CUP
• Applicant: Plus Orthopedics
• Product Code: JDI · Orthopedic
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.

Device Story

PE-PLUS Acetabular Cup is a cemented hip prosthesis component; used in hip arthroplasty to restructure acetabular socket. Device consists of ultra-high molecular weight polyethylene (UHMWPE) cup; accommodates 22mm, 28mm, and 32mm femoral ball heads. Available in multiple sizes to match patient anatomy. Implanted by orthopedic surgeons in clinical/hospital settings. Provides stable bearing surface for hip joint articulation; restores joint function; benefits patients by addressing acetabular socket pathology.

Clinical Evidence

No clinical data provided; substantial equivalence supported by extensive literature review and bench testing.

Technological Characteristics

Material: Ultra-high molecular weight polyethylene (ASTM F 648). Design: Cemented acetabular cup for hip arthroplasty. Sizes: 22mm, 28mm, 32mm head diameters; various cup sizes (42-64mm). Energy source: None (passive implant).

Indications for Use

Indicated for patients undergoing hip arthroplasty requiring acetabular socket restructuring. Contraindications: acute/chronic local or systemic infections; serious lesions of muscles, nerves, or blood vessels endangering the limb; bony defects or poor bone quality compromising prosthesis stability; concurrent disease interfering with implant function.

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

• Implex HEP Acetabular Cup System, Cemented (K971705)
• Howmedica Duration Stabilized UHMWPE Exeter All Plastic Acetabular Component (K972792)

Submission Summary (Full Text)

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K992153

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SEP 2 3 1999

## 510(k) Summary of Safety and Effectiveness

June 25, 1999

- PE-PLUS Acetabular Cup Trade name:
- Common name: Cemented Acetabular Cup
- Prosthesis, hip, semi-constrained, metal/polymer, cemented Classification 21 CFR 888.3350 (87 JDI) name:
- Implex HEP Acetabular Cup System, Cemented (K971705, 08-06-97); Equivalence: Howmedica Duration Stabilized UHMWPE Exeter All Plastic Acetabular Component (K972792, 10-16-97)
- The PE-PLUS Acetabular Cup is made of an ultra high molecular weight Characteristics: polyethylene (ASTM F 648) and accommodates three ball head sizes (diameters of 22, 28, and 32). Twelve sizes are available for the 22 and 28 head diameters, (cup sizes 42 to 64, in 2mm increments) and nine cup sizes for the 32 head diameter (cup sizes 48 to 64, in 2mm increments).
- The PE-PLUS Acetabular Cup is intended for cemented use in hip Indications: arthroplasty where the acetabular socket needs restructuring.
- Contraindications include acute or chronic infections (local or systemic), Contraindications: serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.

Extensive literature has been provided. Performance data:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 23 1999

Mr. Hartmut Loch Chief Executive Officer Plus Orthopedics 3550 General Atomics Court Building 15-100 San Diego, California 92121-1122

Re: K992153 PE-Plus Acetabular Cup Product Code: JDI Class: II Dated: June 25, 1999 Received: June 25, 1999

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 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Hartmut Loch

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" (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,

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):

K992153

Device Name:

PE-PLUS Acetabular Cup

Indications For Use:

The PE-PLUS Acetabular Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs restructuring.

DaOalley

ision of General Restorativ 510(k) Number

1984

Prescription Use
(Per 21 CFR 801.109)