THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ

K992409 · Implex Corp. · JDI · Oct 8, 1999 · Orthopedic

Device Facts

• Record ID: K992409
• Device Name: THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
• Applicant: Implex Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty.

Device Story

Modular acetabular cup system for total hip arthroplasty; used in orthopedic surgery to replace damaged hip joint components. Device features porous surface for bone integration; includes titanium alloy dome hole plug and 6.5 mm diameter cancellous bone screws (20-65 mm lengths). Implanted by orthopedic surgeons in clinical/hospital settings. Provides mechanical stability for hip joint; facilitates cemented, cementless, or hybrid fixation. Benefits patients by restoring joint function and reducing pain associated with severe hip pathology.

Clinical Evidence

Bench testing only. Push-out, lever-out, and torsion testing performed per FDA guidance and ASTM standards to evaluate insert liner and shell assembly performance.

Technological Characteristics

Modular acetabular cup; titanium alloy components; porous surface coating; includes dome hole plug and cancellous bone screws. Mechanical fixation via cemented, cementless, or hybrid techniques. No software or electronic components.

Indications for Use

Indicated for patients with severe hip joint degeneration, trauma, or other pathology requiring cemented, cementless, or hybrid total hip arthroplasty.

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

• The Implex Elliptical Porous Acetabular Cup System (non-modular)
• Biomet Ringloc Acetabular Cup System
• DePuy Duraloc Acetabular Cup System

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS OCT 8 1999

## The Implex Modular Elliptical Porous Acetabular Cup

| 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: | July 19, 1999 |
| Device Trade Name: | The Implex Modular Elliptical Porous Acetabular Cup |
| Device Common<br>Name: | Acetabular Cup |
| Classification Number<br>and Name: | 21 CFR § 888.3358 |
| Substantial<br>Equivalence: | The term "substantial equivalence" as used in this<br>510(k) notification is limited to the definition of<br>substantial equivalence found in the Federal Food,<br>Drug and Cosmetic Act, as amended and as applied<br>under 21 CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or<br>reclassification. A determination of substantial<br>equivalency under this notification is not intended to<br>have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters.<br>No statements related to, or in support of substantial<br>equivalence herein shall be construed as an<br>admission against interest under the US Patent Laws<br>or their application by the courts. |

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| Device Description<br>(cont'd): | 510(k) Summary (Continued) | | |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | The Implex Modular Elliptical Porous Acetabular Cup is intended for use with 6.5 mm diameter cancellous bone screws in 20 to 65 mm lengths, in 5 mm increments. A titanium alloy dome hole plug is available for sealing the central dome hole. | | |
| Indications for Use: | The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty. | | |
| Predicate Devices: | The Implex Elliptical Porous Acetabular Cup System (non-modular). The Biomet Ringloc Acetabular Cup System. The DePuy Duraloc Acetabular Cup System. | | |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device: | The subject device and the predicate devices are manufactured from similar materials, have similar insert locking mechanisms, have similar or the same indications for use, and utilize similar surgical techniques and instrumentation. | | |
| Performance Data: | Push-out, lever-out, and torsion testing per applicable FDA Guidance Documents and ASTM Standards (or draft standards) of the insert liner and shell assembly showed that the subject device possesses performance characteristics similar to several legally marketed devices. | | |
| Conclusion: | The Implex Modular Elliptical Porous Acetabular Cup is substantially equivalent to the identified predicate devices. | | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

Mr. John A. Schalago, RAC Manager, Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale. New Jersey 07401-1600

Re: K992409

> Trade Name: The Implex Modular Elliptical Porous Acetabular Cup Regulatory Class: II Product Code: LPH, JDI Dated: July 19, 1999 Received: July 20, 1999

Dear Mr. Schalago:

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 Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality 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 - Mr. John A. Schalago

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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Implex Corp

510(k) Number (if known) :

K 992409

Device Name:

The Implex Modular Elliptical Porous Acetabular Cup

Indications For Use:

The Implex Modular Elliptical Porous Acetabular Cup is intended for use where severe degeneration, trauma, or other pathology of the hip joint indicates cemented, cementless or hybrid total hip arthroplasty.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K992409 |

| Prescription Use (Per 21 CFR 801.109) | Yes |
|---------------------------------------|-----|
|---------------------------------------|-----|

OR...

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

(Optional Format 1-2-96)