IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED

K971705 · Implex Corp. · JDI · Aug 6, 1997 · Orthopedic

Device Facts

• Record ID: K971705
• Device Name: IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
• Applicant: Implex Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The use of the Implex HEP Acetabular Cup System, Cemented, is indicated for: a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular necrosis; b) Secondary revision of a previously unsuccessful acetabular component; c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results; d) Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained; e) Non-union of femoral neck or head fractures; and f) Salvage of a failed primary or secondary total or hemi hip.

Device Story

Implex HEP Acetabular Cup System is a cemented acetabular component for total hip replacement. Device consists of a shell made of Hedrocel® material, available in OD sizes 40-70 mm and ID sizes 22, 26, 28, and 32 mm. Implanted using specialized Implex Acetabular Cup Instrumentation System. Used by orthopedic surgeons in clinical settings to replace damaged acetabular surfaces. Provides a stable bearing surface for hip joint articulation, aiming to restore joint function and alleviate pain in patients with severe hip pathology.

Clinical Evidence

Bench testing only. Performance characteristics and material properties were evaluated under defined laboratory conditions to support substantial equivalence.

Technological Characteristics

Acetabular cup system; material: Hedrocel®; dimensions: 40-70 mm OD, 22-32 mm ID; intended for cemented fixation; surgical instrumentation system required for implantation.

Indications for Use

Indicated for patients requiring total hip replacement due to degenerative arthritis, avascular necrosis, fracture dislocation, irreducible fractures, non-union of femoral neck/head fractures, or salvage of failed primary/secondary hip procedures.

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

• Implex A-230 Porous Acetabular Cup System, Cemented
• Implex Hedrocel® Acetabular Restrictor

Submission Summary (Full Text)

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Implex Corp. 510(k) Premarket Notification Number K971705

1971705

AUG - 6 - 557

## 510(k) SUMMARY - IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED

| Submitter Name: | Implex Corp. |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 80 Commerce Drive<br>Allendale, New Jersey 07401-1600 |
| Contact Person: | Robert Cohen or Robert Poggie |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | July 28, 1997 |
| Device Trade Name: | Implex HEP Acetabular Cup System, Cemented |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component, Cemented |
| Predicate Device(s): | Implex A-230 Porous Acetabular Cup System, Cemented;<br>Implex Hedrocel® Acetabular Restrictor |
| Device Description: | Implex HEP Acetabular Cups, Cemented, are available in<br>OD sizes from 40 mm to 70 mm (in 2 mm increments), and<br>with four possible ID size options (22 mm, 26 mm, 28 mm,<br>and 32 mm). Implex HEP Acetabular Cups are to be<br>implanted using the Implex Acetabular Cup Instrumentation<br>System. |
| Indications for Use: | The use of the Implex HEP Acetabular Cup System,<br>Cemented, is indicated for: |
| | a) Total Hip Replacement in severely disabled joints as<br>a result of degenerative arthritis or avascular<br>necrosis; |
| | b) Secondary revision of a previously unsuccessful<br>acetabular component; |
| | c) Other hip problems where clinical experience has<br>shown that alternative modes of treatment are less<br>likely to achieve satisfactory results; |
| | d) Fracture dislocation of the hip, or irreducible<br>fractures in which adequate fixation cannot be<br>obtained; |
| | e) Non-union of femoral neck or head fractures; and |
| | f) Salvage of a failed primary or secondary total or<br>hemi hip. |
| Device Technological<br>Characteristics and<br>Comparison to<br>Predicate Device(s): | The surgical instrumentation and design geometry of the<br>predicate Implex A-230 Porous Acetabular Cup System,<br>Cemented, and the Implex HEP acetabular Cup System,<br>Cemented, are equivalent. The primary difference between<br>the two device systems is that the Implex HEP Acetabular<br>Cup, Cemented shell is comprised of Hedrocel®, and the<br>Implex A-230 Porous Acetabular Cup is comprised of<br>porous coated titanium alloy.<br><br>The Hedrocel® material used in the Implex HEP Acetabular<br>Cup System, Cemented, is identical to the Hedrocel®<br>material which comprises the Implex Hedrocel® Acetabular<br>Restrictor. |
| Performance Data: | Testing conducted to characterize the materials and the<br>performance characteristics of the device under defined<br>laboratory conditions was provided to support a finding of<br>substantial equivalence. |
| Conclusion: | The Implex HEP Acetabular Cup System, Cemented, is<br>substantially equivalent to the identified predicate devices. |

: ১১২

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## 510(k) Summary, Continued

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or a caduceus, composed of three interconnected profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Glenn N. Byrd, MBA Associate Director of Regulatory Affairs Advanced Bioresearch Associates ... ... . . Authorized Requlatory Agent for Implex Corporation 1700 Rockville Pike, Suite 450 Rockville, Maryland 20852-1631

AUG - 6 1997

Re : K971705 Implex HEP Acetabular Cup System, Cemented Requlatory Class: II Product Code: JDI Dated: May 8, 1997 Received: May 8, 1997

Dear Mr. Byrd:

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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Dovices: 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 requlatory 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 requlations.

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## Page 2 - Glenn N. Byrd, MBA

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 gener Other qeneral 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.qov/cdrh/dsmamain.html".

Sincerely yours,

S. Galin M. Witter, Ph.D., M.

a 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): | K971705 |
|---------------------------|-----------------------------------|
| Device Name: | Implex HEP Acetabular Cup System, |

Device Name.

Cemented

Indications For Use: . . . . . .

The use of the Implex HEP Acetabular Cup System, Cemented, is indicated for:

- Total Hip Replacement in severely disabled joints a) as a result of degenerative arthritis or avascular necrosis;
- Secondary revision of a previously unsuccessful b) acetabular component;
- Other hip problems where clinical experience has C) shown that alternative modes of treatment are less likely to achieve satisfactory results;
- Fracture dislocation of the hip, or irreducible d ) fractures in which adequate fixation cannot be obtained;
- Non-union of femoral neck or head fractures; and e )
- £) Salvage of a failed primary or secondary total or hemi hip.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

sion (Sign-Off)
of Generai Restorative Devices
10(K) Number K971705

Prescription Use (Per 21 CFR 801.109)

OR ...

Over-The-Counter Use

(Optional Format 1-2-96)