IMPLEX A-240 HEP ACETABULAR CUP SYSTEM

K964509 · Implex Corp. · LPH · Jun 19, 1997 · Orthopedic

Device Facts

• Record ID: K964509
• Device Name: IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
• Applicant: Implex Corp.
• Product Code: LPH · Orthopedic
• Decision Date: Jun 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The use of the Implex A-240 HEP Acetabular Cup System 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 A-240 HEP Acetabular Cup System is a non-cemented acetabular component for total hip replacement. Device consists of porous tantalum shell; available in OD sizes 40-72 mm and ID sizes 22, 26, 28, 32 mm. Implanted using Implex Acetabular Cup Instrumentation System. Used by orthopedic surgeons in clinical settings to replace damaged acetabular surfaces. Provides stable fixation for hip joint reconstruction; benefits patients by restoring joint function and alleviating pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Non-cemented acetabular cup. Shell material: porous tantalum. Dimensions: 40-72 mm OD, 22-32 mm ID. Implanted via dedicated instrumentation system.

Indications for Use

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

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.

Predicate Devices

• Implex A-230 Porous Acetabular Cup System, Non-Cemented

Submission Summary (Full Text)

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JUN 19 1997
K964509

# 510(k) SUMMARY - IMPLEX A-240 HEP ACETABULAR CUP SYSTEM

| Submitter Name: | Implex Corp. |
| --- | --- |
| Submitter Address: | 80 Commerce Drive
Allendale, New Jersey 07401-1600 |
| Contact Person: | Robert Cohen or Robert Poggie |
| Phone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | November 8, 1996 |
| Device Trade Name: | Implex A-240 HEP Acetabular Cup System |
| Device Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, Hip, Acetabular Component, Non-Cemented |
| Predicate Device: | Implex A-230 Porous Acetabular Cup System, Non-Cemented |
| Device Description: | Implex A-240 HEP Acetabular Cups are available in OD sizes from 40 mm to 72 mm (in 2 mm increments), and with 4 possible ID size options (22 mm, 26 mm, 28 mm, and 32 mm). Implex A-240 HEP Acetabular Cups are to be implanted using the Implex Acetabular Cup Instrumentation System. |
| Indications For Use: | The use of the Implex A-240 HEP Acetabular Cup System 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. |

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## Device Technological Characteristics and Comparison to Predicate Device:

The surgical instrumentation and design geometry of the predicate Implex A-230 Porous Acetabular Cup System, Non-Cemented, and the Implex A-240 HEP Acetabular Cup System are equivalent. The primary difference between the two device systems, is the porous metal of the shell. The Implex A-240 HEP Acetabular Cup shell is comprised of porous tantalum, and the Implex A-230 Porous Acetabular Cup is comprised of porous coated titanium alloy.

## Performance Data:

Testing conducted to characterize the materials and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence.

## Conclusion:

The Implex A-240 HEP Acetabular Cup System is substantially equivalent to the predicate device in terms of intended use, safety, and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Glenn N. Byrd, MBA
Associate Director of Regulatory Affairs
Advanced Bioresearch Associates
1700 Rockville Pike, Suite 450
Rockville, Maryland 20852-1631

JUN 19 1997

Re: K964509
Trade Name: Implex A-240 HEP
Acetabular Cup System
Regulatory Class: II
Product Code: LPH
Dated: March 21, 1997
Received: March 21, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic

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Page 2 - Glenn N. Byrd, MBA

GMP 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.

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): K964509

Device Name: Implex A-240 HEP Acetabular Cup System

Indications For Use:

The use of the Implex A-240 HEP Acetabular Cup System 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.

(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 K964509

Prescription Use ☐
(Per 21 CFR 801.109)

OR...

Over-The-Counter Use ☐

(Optional Format 1-2-96)

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