HEDROCEL ACETABULAR CAGE SYSTEM

K983837 · Implex Corp. · LPH · Jul 1, 1999 · Orthopedic

Device Facts

• Record ID: K983837
• Device Name: HEDROCEL ACETABULAR CAGE SYSTEM
• Applicant: Implex Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Jul 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use of the Implex Hedrocel® Acetabular Cage are as follows: • For cemented or cementless use. • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis. • Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. • Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Device Story

Acetabular reconstructive cage system; consists of Hedrocel® shell and Implex All-Poly cup; used for cemented or cementless hip arthroplasty. Operates as mechanical support for acetabular reconstruction; All-Poly cup affixed to cage via acrylic bone cement. Used in clinical/surgical settings by orthopedic surgeons. Provides structural stability for hip joint in cases of poor bone stock or revision surgery; facilitates joint function restoration; benefits patient by addressing disabling joint disease.

Clinical Evidence

Bench testing only. Testing conducted on commercially available devices comprised wholly or in part of Hedrocel® and the Hedrocel Acetabular Cage System indicates the device functions as intended.

Technological Characteristics

Acetabular cage system; Hedrocel® material; compatible with All-Poly cups (22mm-32mm ID; 0°/10° face angles); cage OD sizes 52mm-70mm; All-Poly cup OD sizes 40mm-58mm. Fixation via acrylic bone cement. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative arthritis, rheumatoid arthritis, late-stage avascular necrosis), patients requiring revision of unsuccessful prior hip procedures, or patients with poor/inadequate acetabular bone stock where other reconstructive techniques are unsuitable.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The Implex Hedrocel® Acetabular Cage System

| Submitter Name: | Implex Corp. | K983831 |
|-------------------------|-------------------------------------------------------|---------|
| 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: | June 17, 1999 | |
| Device Trade Name: | The Implex Hedrocel® Acetabular Cage System | |
| Device Common Name: | Acetabular Reconstructive Cage | |
| Classification Number : | 21 CFR § 888.3350 | |

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 device can be marketed without which a or reclassification. premarket approval (1) 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 substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Device Description: The Hedrocel® Acetabular Cage System consists of the Hedrocel® Acetabular Cage configured with an Implex All-Poly Cup. The Hedrocel® Acetabular Cage System, cemented and cementless, is available in OD sizes from 52 mm to 70 mm in 2 mm increments. The Hedrocel Acetabular Cage (Shell) is compatible with All-Poly Cups in OD sizes from 40 mm to 58 mm. The All-Poly Cups, cemented, are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0° and 10° face angles. The All-Poly Cup is affixed to the Hedrocel® Acetabular Cage using acrylic bone cement.

> The Hedrocel® Acetabular Cage may be used with Continuum Hip Bone Screws.

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| Indications for Use: | The indications for use of the Implex Hedrocel®<br>Acetabular Cage are as follows:<br>• For cemented or cementless use.<br>• Painful, disabling joint disease of the hip<br>resulting from: degenerative arthritis,<br>rheumatoid arthritis or late stage avascular<br>necrosis.<br>• Revision of previous unsuccessful femoral<br>head replacement, cup arthroplasty or other<br>procedure.<br>• Clinical management problems where<br>arthrodesis or alternative reconstructive<br>techniques are less likely to achieve<br>satisfactory results.<br>• Where bone stock is of poor quality or is<br>inadequate for other reconstructive<br>techniques as indicated by deficiencies of<br>the acetabulum. |
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| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device: | A comparison of technical characteristics included in<br>this 510(k) Premarket notification demonstrates that<br>the Hedrocel® Acetabular Cage System is<br>substantially equivalent to commercially available<br>reconstructive devices. |
| Performance Data: | Testing conducted on the commercially available<br>devices comprised wholly or in part of Hedrocel® and<br>the Hedrocel Acetabular Cage System indicate that<br>the device will function as intended. |
| Conclusion: | The Implex Hedrocel® Acetabular Cage is<br>substantially equivalent to the identified predicate<br>devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

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

Re: K983837

Implex Hedrocel® Acetabular Cage System for Cemented or Cementless Fixation Regulatory Class: II Product Code: LPH and JDI Dated: April 21, 1999 Received: April 22, 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 (OS) 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.

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.

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Page 2- Mr. John Schalago

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

P. Cotter

- 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):

K983837

Device Name:

The Hedrocel® Acetabular Cage System

Indications For Use:

The indications for use of the Implex Hedrocel® Acetabular Cage are as follows:

- For cemented or cementless use. .
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty ● or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive . techniques as indicated by deficiencies of the acetabulum.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K983835 |

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

OR...

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