SMC 28MM CERAMIC FEMORAL HEADS

K981302 · Signal Medical Corp. · LZO · Jun 25, 1998 · Orthopedic

Device Facts

• Record ID: K981302
• Device Name: SMC 28MM CERAMIC FEMORAL HEADS
• Applicant: Signal Medical Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1 . . OSTEOARTHRITIS 2 . RHEUMATOID ARTHRITIS 3. TRAUMATIC ARTHRITIS 4 . WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE.

Device Story

SMC 28mm Ceramic Femoral Head; manufactured from zirconium oxide; intended for use as a component in hip arthroplasty. Device design features three sizes (-3.5, 0, +3.5) identical to previously cleared cobalt chrome femoral heads. Must be used exclusively with Signal Medical Corporation (SMC) femoral hip components featuring 5.708-degree trunnions. Device is non-resterilizable. Used by orthopedic surgeons in clinical settings to replace the femoral head in hip joint reconstruction; provides a bearing surface for hip arthroplasty; intended to restore joint function and alleviate pain associated with degenerative or traumatic arthritis.

Clinical Evidence

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

Technological Characteristics

Material: Zirconium oxide ceramic. Dimensions: 28mm diameter, available in three sizes (-3.5, 0, +3.5). Interface: 5.708-degree trunnion compatibility with SMC cobalt-chrome femoral stems. Non-resterilizable.

Indications for Use

Indicated for patients with osteoarthritis, rheumatoid arthritis, or traumatic arthritis where conservative procedures have failed or are unacceptable.

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

• Signal Medical Corporation 510K (K971681)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN 25 1998

## 510K SUMMARY OF SAFETY AND EFFECTIVENESS

The Signal Medical Corporation 28mm Ceramic Femoral Heads are manufactured from zirconium oxide. The design is made available in three (3) sizes identical to the cobalt chrome femoral heads in the Signal Medical Corporation 510K (K971681) (-3.5, 0, +3.5). These ceramic femoral heads should only be used on the Signal Medical Corporation (SMC) femoral component of the hip, and should never be resterilized.

Indications for use

- Osteoarthritis ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- 2. Rheumatoid Arthritis
- rn Traumatic Arthritis
- Where the use of a more conservative procedure has failed or is 4. unacceptable.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The caduceus is represented by three abstract, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1998

Louis A. Serafin, Jr., M.D. Signal Medical Corporation 3315 Berry Drive Lakeport, Michigan 48059

Re : K981302 SMC Ceramic Femoral Head - 28 mm Regulatory Class: II Product Code: LZO Dated: April 6, 1997 Received: April 9, 1997

Dear Dr. Serafin:

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 Signal Medical Corporation's 28 mm Zirconia Ceramic Femoral Head is only to be used with Signal Medical Corporation's cobalt-chrome hip stems with the 5.708 degree trunnions. This information must be identified in the package insert.

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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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

{2}------------------------------------------------

Page 2 - Louis A. Serafin, Jr., M.D.

comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron. In daureror, 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 enrough Siz or on Control provisions, or other Federal Laws or Regulations.

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

{3}------------------------------------------------

් ක්‍රමුණු ලැබූ බැඳින් පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහ 659 11 1

#### 510(k) Number (if known):

Device Names SMC 28MM CERAMIC FEMORAL HEAD

#### Indications For Use:

- 1 . . OSTEOARTHRITIS
- RHEUMATOID ARTHRITIS 2 .
- 3. TRAUMATIC ARTHRITIS
- WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED 4 . OR IS UNACCEPTABLE.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODDE)

| Prescription Use | <div style="text-align: left;"><div style="float: left;">X</div></div> | OR | Over-The- |
|----------------------|------------------------------------------------------------------------|----|-----------|
| Counter Use | | | |
| (Per 21 CFR 801.109) | | | |

| (Division Sign-Off) | | (Optional Format |
|-----------------------------------------|---------|------------------|
| Division of General Restorative Devices | | |
| 510(k) Number | K981302 | |