IMPLEX ALUMINA FEMORAL HEAD

K990183 · Implex Corp. · LZO · Jun 11, 1999 · Orthopedic

Device Facts

• Record ID: K990183
• Device Name: IMPLEX ALUMINA FEMORAL HEAD
• Applicant: Implex Corp.
• Product Code: LZO · Orthopedic
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of: 1. Severely disabled joints as a result of degenerative arthritis or avascular necrosis. 2. Secondary revision of a previously unsuccessful femoral component or total hip replacement. 3. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results. 4. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained. 5. Non-Union of femoral neck or head fractures. 6. Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

Device Story

Implex Alumina Femoral Head is a ceramic component for total hip arthroplasty; provides articulation surface. Device features 28 mm outer diameter with varying neck offset lengths (+0, +3, +6 mm); designed for compatibility with 12/14 locking taper femoral stems. Used by orthopedic surgeons in clinical settings during hip replacement procedures. Device replaces damaged femoral head to restore joint function; benefits patients by providing durable, biocompatible articulation surface for hip joint mobility.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ceramic (alumina) femoral head; 28 mm outer diameter; 12/14 locking taper interface. Standalone mechanical implant.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to degenerative arthritis, avascular necrosis, failed previous hip replacements, hip fracture dislocations, irreducible fractures, or non-union of femoral neck/head fractures.

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.

Submission Summary (Full Text)

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JUN 11 1999

## K990183 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Implex Alumina Femoral Head

| Submitter Name: | Implex Corp. |
|------------------------------------|-------------------------------------------------------|
| Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Contact Person: | John Schalago or Robert Poggie |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | January 11, 1999 |
| Device Trade Name: | Implex Alumina Femoral Head |
| Device Common<br>Name: | Ceramic femoral head |
| Classification Number<br>and Name: | 21 CFR § 888.3353 |

Substantial Equivalence:

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of equivalence herein shall substantial be construed as an admission against interest under the US Patent Laws or their application by the courts.

- Device Description: The Implex Alumina Femoral Head is a ceramic femoral head. The Implex Alumina Femoral Head is offered in a 28 mm OD with +0, +3, and +6 neck offset lengths, and is intended for use with all legally Femoral Continuum Hip System marketed Components with a 12/14 locking taper.

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## Indications for Use:

The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:

- disabled joints as a result of 1. Severely degenerative arthritis or avascular necrosis.
- 2. Secondary revision of a previously unsuccessful femoral component or total hip replacement.
- 3. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
- 4. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
- 5. Non-Union of femoral neck or head fractures.
- 6. Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

A comparison of device characteristics, materials, intended use and indications for use to commercially available ceramic femoral heads provided in this premarket notification support the determination that the Implex Alumina Femoral Head is substantially equivalent to legally marketed ceramic head components.

Mechanical test data provided in this premarket notification demonstrates that the Alumina Femoral Head will perform as intended.

The Implex Alumina Femoral Head is substantially equivalent to the identified predicate devices.

Device Technological Characteristics and Comparison to Predicate Device:

Performance Data:

Conclusion:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Robert A. Poggie, Ph.D. Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

K990183 Re : Implex Alumina Femoral Head Trade Name: Regulatory Class: II Product Code: LZO Dated: April 23, 1999 Received: April 26, 1999

Dear Dr. Pogqie:

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 Requlations, Title 21, Parts 800 to 895. ಕ 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 requlation 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 regulations.

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Page 2 - Robert A. Poggie, Ph.D.

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 leqally 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) :

K990183

Device Name:

Implex Alumina Femoral Head

Indications For Use:

The Implex Alumina Femoral Head is intended to provide articulation in total hip procedures in cases of:

- 1. Severely disabled joints as a result of degenerative arthritis or avascular necrosis.
- 2. Secondary revision of a previously unsuccessful femoral component or total hip replacement.
- 3. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results.
- 4. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained.
- 5. Non-Union of femoral neck or head fractures.
- 6. Salvage of a failed primary or secondary total hip or hemi-hip arthroplasty.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990183 |

| Prescription Use<br>(Per 21 CFR 801.109) | Yes |
|------------------------------------------|-----|
|------------------------------------------|-----|

OR...

| Over-The-Counter Use | No |
|----------------------|----|
|----------------------|----|

(Optional Format 1-2-96)

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January 11, 1999