ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32

K030153 · Zimmer, Inc. · JDI · Apr 1, 2003 · Orthopedic

Device Facts

• Record ID: K030153
• Device Name: ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
• Applicant: Zimmer, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Apr 1, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Device Story

ZCA Snap-In Cup is a single-unit ultra-high molecular weight polyethylene (UHMWPE) acetabular prosthesis; designed for cemented fixation in hip arthroplasty. Features include hemispherical shape; 32 mm head snap-fit capability via material interference; four PMMA cement spacers for 3 mm cement mantle; radiopaque stainless steel wires for radiographic orientation; outer surface grooves/scallops for cement interdigitation. Used by orthopedic surgeons in clinical/OR settings to replace damaged acetabular bearing surfaces. Benefits include restoration of hip function in patients with degenerative joint disease.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Material: Ultra-high molecular weight polyethylene (UHMWPE). Fixation: Cemented (PMMA spacers). Features: Radiopaque stainless steel wires for imaging; grooves/scallops for cement interdigitation. Dimensions: 49-61 mm outer diameter (2 mm increments).

Indications for Use

Indicated for skeletally mature individuals undergoing primary or revision hip surgery for noninflammatory degenerative joint disease (NIDJD), including osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, and diastrophic variant.

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

• Trapezoidal-28® "Snap-On" Acetabular Cup
• Müller Snap-On Acetabular Cup
• Zimmer Non-Metal Backed Acetabular Cup for Cemented Fixation (K901240)
• ULTIMA All-UHMWPE Cemented Acetabular Cups (K924115)
• Trilogy® Acetabular System Elevated Rim Liners (K934765)

Submission Summary (Full Text)

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APR 01 2003

K030153

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## Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | January 8, 2003 |
| Trade Name: | ZCA® All-Poly Acetabular Cup, Snap-In |
| Common Name: | All Polyethylene Acetabular Cup |
| Classification Names<br>and References: | Hip joint metal/polymer semi-constrained cemented<br>prosthesis (21 CFR § 888.3350) |
| Predicate Devices: | Trapezoidal-28® "Snap-On" Acetabular Cup<br>(preamendment device), manufactured by Zimmer,<br>Inc.<br>Müller Snap-On Acetabular Cup (postamendment<br>device), manufactured by Zimmer, Inc.<br>Zimmer Non-Metal Backed Acetabular Cup for<br>Cemented Fixation (formerly Astel), K901240,<br>cleared March 26, 1990<br>ULTIMA All-UHMWPE Cemented Acetabular<br>Cups, manufactured by Johnson & Johnson,<br>K924115, cleared November 24, 1992<br>Trilogy® Acetabular System Elevated Rim Liners,<br>manufactured by Zimmer, K934765, cleared April<br>29, 1994 |
| Device Description: | The ZCA Snap-In Cup is a single unit manufactured<br>from ultra-high molecular weight polyethylene<br>(UHMWPE). The interior of the cup is designed to<br>allow snap fitting of a 32 mm head into the |

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030/53
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articular surface through matcrial interference around the inner diameter rim. The ZCA Snap-In Cup is designed with a neutral face and is provided in outer diameter sizes ranging from 49 to 61 mm in 2 mm increments to fit varying anatomical requirements. The ZCA Snap-In Cup is hemispherical in shape and has four press-fit PMMA cement spacers affixed to the outer diameter to centralize the cup and help maintain a uniform 3 mm cement mantle. Radiopaque stainless steel wires at the dome and equator are used to determine the location and orientation of the component radiographically. Grooves and scallops on the outer surface are used for optimal cement interdigitation.

The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NID.JD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis. slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The acetabular cups listed above are substantially equivalent to each other and the ZCA Snap-In Cup in that all are manufactured from the same or similar materials and are intended to replace the bearing surface of the acetabulum.

## Intended Use:

Comparison to Predicate Devices:

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APR 0 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Cain Manager, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, IN 46581-0708

Re: K030153

Trade Name: ZCA All Poly Acetabular Cup, Snap-In Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI Dated: January 8, 2003 Received: January 16, 2003

Dear Ms. Cain:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Karen Cain

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 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,

Mark N. Milburn

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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## Indications for Use

KO30153

510(k) Number (if known):

Device Name:

ZCA® All-Poly Acetabular Cup, Snap-In

Indications for Use:

The acetabular cup is intended for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJ) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fuscd hip, fracture of the pelvis, and diastrophic variant.

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (OD) E

(ODE)

Mark A. Milkevar

(Division Sign-Off)

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Division of G storative and Neurological

510(k) Number K030153

Prescription Use (Por 21 CFR 801.109) OR

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