S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD

K973307 · Johnson & Johnson Professionals, Inc. · LZO · Nov 20, 1997 · Orthopedic

Device Facts

• Record ID: K973307
• Device Name: S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 20, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

Device Story

S-ROM Zirconia Ceramic Femoral Head; prosthetic component for total hip replacement. Manufactured from Yttrium Stabilized Zirconium Oxide (PROZYR). Designed for use with S-ROM Total Hip System femoral stems; specifically titanium alloy (Ti6Al4V) stems with 11/13 Morse taper trunnions. Implanted by orthopedic surgeons in clinical settings. Functions as articulating surface in hip joint; must be paired with UHMWPE or metal-backed UHMWPE acetabular cups. Provides structural replacement for damaged hip joints; restores mobility; reduces pain. Device is passive implant; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Yttrium Stabilized Zirconium Oxide (Zirconia/PROZYR). Form factor: Femoral head for total hip arthroplasty. Interface: 11/13 Morse taper trunnion for titanium alloy (Ti6Al4V) stems. Compatibility: Restricted to UHMWPE or metal-backed UHMWPE acetabular cups. Passive mechanical device.

Indications for Use

Indicated for patients requiring total hip replacement or revision due to severe pain/disability from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fractures (traumatic/non-union), congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, or previous fusion. Contraindicated for use with acetabular components other than UHMWPE or metal-backed UHMWPE cups.

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

• P.F.C. Zirconia Ceramic Hip Head (K962248, K933275)
• S-ROM Zirconia Ceramic Hip Head (K921111)

Submission Summary (Full Text)

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K973307

arti nesser in

# NOV 2 0 1997

Summary of Safety and Effectiveness Data for the S-ROM® Zirconia Ceramic Femoral Head

> Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person_

Mary E. Gray Associate Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

Name of Device

| Proprietary Name: | S-ROM Zirconia Ceramic Femoral Head |
|----------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Hip Prosthesis |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis. |
| Regulatory Class: | Class II by 21 CFR 888.3353 |
| Product Code: | 87 LZO |
| Owner/Operator No.: | 9001269 |

#### Device Classification_

This device has been placed in Class II for Hip joint metal/ ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR § 888.3353.

#### Statement of Substantial Equivalence_

The S-ROM Zirconia Ceramic Hip Head is identical in material (PROZYR®) and in function (indicated use) to the P.F.C. Zirconia Ceramic Hip Head cleared for marketing under premarket notifications K# 962248 (August 29, 1996)/ K# 933275 (September 28, 1994).

The S-ROM Zirconia Ceramic Hip Head is identical in design (drawing specifications) and function (indicated use) to the S-ROM Zirconia Ceramic Hip Head cleared for marketing under premarket notification K# 921111.

The subject device is composed of similar materials to the predicate device mentioned above (P.F.C. Zirconia Ceramic Hip Head). Further, the intended use and the manufacture of the S-ROM Ziconia Ceramic Hip Head are substantially equivalent to those already cleared for domestic commercial distribution.

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Additionally, the packaging and method of sterilization utilized for the S-ROM Zirconia Ceramic Hip Head are the same as those used for the previously mentioned predicate device.

#### Indications for Use

The S-ROM Zirconia Ceramic Hip Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, traumatic and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

### Physical Description_

The S-ROM Zirconia Ceramic hip head is manufactured of Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR®. The S-ROM ceramic hip heads are designed to be used with the S-ROM Total Hip System femoral stems.

The ceramic femoral heads are contraindicated for use with any acetabular components other than an UHMWPE cup or metal backed UHMWPE cup.

S-ROM® Zirconia Ceramic Femoral Heads

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Ms. Mary E. Gray Associate Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive 02767-0350 Raynham, Massachusetts

Re: K973307 S-ROM® Zirconia Ceramic Femoral Hip Head for Use with the S-ROM® Total Hip System Regulatory Class: II Product Code: Code: TLLO Trip Dated: September 2, 1997 Received: September 3, 1997

Dear Ms. Gray:

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 and the following limitation that the package insert must reflect that the S-ROM Zirconia Ceramic Femoral Hip Heads are to be used only with titanium alloy (Ti6Al4V) hip stems with the 11/13 Morse taper trunnions.

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to

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Page 2 - Ms. Mary E. Gray

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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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## Indications for Use for the S-ROM® Zirconia Ceramic Femoral Head

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

## Indications of Use

The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

Prescription Use
(Per 21 CFR 801.109)

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(Division Sign-Off) (Division of General Restorative Devices 1697370 \$10(k) Number .

S-ROM® Zirconia Ceramic Femoral Heads