OPERA CUPFLANGED ACETABULAR COMPONENTS

K991538 · Smith & Nephew, Inc., Orthopaedic Div. · JDI · Jun 3, 1999 · Orthopedic

Device Facts

• Record ID: K991538
• Device Name: OPERA CUPFLANGED ACETABULAR COMPONENTS
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: JDI · Orthopedic
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Opera Cup is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Device Story

Opera Cup is a hemispherical, all-polyethylene acetabular component featuring a non-concentric, trimmable flange for improved cement containment and pressurization. Designed for use in primary and revision total hip arthroplasty. Features concentric outer grooves and an embedded wire marker for radiographic visualization. Implanted by orthopedic surgeons in a clinical/hospital setting. The trimmable flange allows customization to patient anatomy, facilitating secure cement fixation. Benefits include restoration of hip function and stability in patients with degenerative or traumatic joint disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Ultra-High-Molecular-Weight Polyethylene (ASTM F-648). Form factor: Hemispherical cup with non-concentric, trimmable flange and concentric outer grooves. Includes wire marker for radiographic identification. Intended for cemented fixation.

Indications for Use

Indicated for patients undergoing primary or revision hip surgery due to trauma, noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), remote osteomyelitis, or complex proximal femur fractures/nonunions requiring endoprosthesis, osteotomy, or Girdlestone resection.

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

• Spectron All-Polyethylene Acetabular Component
• Depuy OGEE® Flanged Acetabular Cup
• Depuy All-Polyethylene Cemented Acetabular Cup

Submission Summary (Full Text)

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## 510(k) Summary OPERA CUP

< 99 1538

## All- polyethylene acetabular flanged component

Smith & Nephew, Inc., Orthopaedic Division Submitter's name: 1450 Brooks Road, Memphis, TN 38116 Submitter's address: Submitter's telephone number: 901/399-5153 Janet Johnson Green Contact person: April 26, 1999 Date summary prepared: Trade or proprietary device name: OPERA CUP

Common or usual name: Classification name:

Acetabular component Title 21 CFR 888.3353 Hip Joint metal/ ceramic/ polymer semi-Constrained cemented or non-porous uncemented Prosthesis.

87JDI Device Product Code and Panel Code:

Substantially Equivalent, Legally Marketed Predicate Devices: Spectron All-Polyethylene Acetabular Component Depuy OGEE® Flanged Acetabular Cup Depuy All-Polyethylene Cemented Acetabular Cup

#### Subject device description:

The Opera Cup all-polyethylene acetabular component is a hemispherical cup with a non-concentric flange protruding from its rim. The component is made from Ultra-High-Molecular-Weight Polyethylene (ASTM F-648). The outer surface of the hemisphere has concentric grooves around the periphery. A wire marker is located in the one of the grooves for implant location on X-ray. The flange is designed to be trimmed to conform with the anatomy of the individual patient to allow closure at the acetabular rim; thus ensuring good cement containment and pressurization.

#### Subject device intended use:

The Opera Cup is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma ornoninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenitaldysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

### Technological Characteristics:

The Opera Cup is similar to the legally marketed devices listed above in that these devices are indicated for total hip replacement, are manufactured from similar or like materials, and are similar in technological characteristics.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its body and wings. The bird is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 1999

Ms. Janet Johnson Green Clinical and Regulatory Affairs Smith & Nephew, Inc. 1450 Brooks Road 38116 Memphis, Tennessee

Re: K991538 Opera Cup Flanged Acetabular Components Trade Name: Regulatory Class: II Product Codes: JDI and LZO Dated: April 30, 1999 May 3, 1999 Received:

Dear Ms. Green:

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 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 Requlations, Title 21, Parts 800 to 895. ਜ 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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#### Page 2 - Ms. Janet Johnson Green

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 [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): _K991538

Opera Cup Flanged Acetabular Components Device Name: _

Indications For Use:

. 1

The Opera Cup is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) of any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

It is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainagefree period, in which case, the patient should be warned of an above normal danger of infection postoperatively: treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques, endoprosthesis, femoral osteotomy, or Girdlestone resection fracture-dislocation of the hip; and correction of deformity.

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> > Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of General Restorative Devices K9915 510(k) Nümber -

Prescription Use *X*
(Per 21 CFR 801.109)

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Over-The-Counter Use_

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