OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS

K974685 · Osteonics Corp. · JDI · Sep 22, 1998 · Orthopedic

Device Facts

• Record ID: K974685
• Device Name: OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
• Applicant: Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis, post-traumatic 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; and, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Device Story

Osteonics® Crossfire™ Polyethylene Acetabular Components are orthopedic implants used in total hip arthroplasty. These inserts are designed to mate with metal acetabular shells, femoral bearings, and femoral hip stems. The device functions as a bearing surface within the hip joint to facilitate movement and reduce pain in patients with degenerative or traumatic joint disease. The primary innovation is the use of crosslinked ultra-high molecular weight polyethylene (UHMWPE), which demonstrates significantly reduced gravimetric wear rates compared to standard polyethylene in in vitro simulations. The device is intended for surgical implantation by orthopedic surgeons in a hospital or clinical setting. By providing a durable, low-wear bearing surface, the device aims to improve the longevity and clinical outcomes of hip replacement procedures.

Clinical Evidence

No clinical data provided. Evidence consists of bench-only in vitro hip joint simulation testing. Testing compared crosslinked polyethylene to standard polyethylene over 5 million cycles using a 28mm CoCr counterface and bovine calf serum. Results showed 90% reduction in gravimetric wear rate (standard), 88% reduction (accelerated aging), and 78% reduction (abrasive conditions).

Technological Characteristics

Material: Ultra-high molecular weight polyethylene (UHMWPE) per ASTM F-648. Components include various cup inserts (Omnifit® Series II, Eccentric). Designed for cemented or cementless total hip arthroplasty. Features include elevated rims and specific bearing thicknesses. Sterilization method not specified.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative, rheumatoid, post-traumatic arthritis, or late-stage avascular necrosis), patients requiring revision of failed femoral head replacement or cup arthroplasty, and patients where arthrodesis or other reconstructive techniques are unsatisfactory or bone stock is inadequate.

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

• Osteonics® Polyethylene Acetabular Components (standard polyethylene counterparts)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary Osteonics® Polyethylene Acetabular Compor

| Sponsor of the 510(k) Submission: | Osteonics Corporation<br>59 Route 17<br>Allendale, NJ 07401-1677<br>201-825-4900 |
|-----------------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Donna S. Wilson<br>Regulatory Affairs Specialist |
| Date 510(k) Summary Prepared: | August 27, 1998 |
| Device Proprietary Name: | Osteonics® Polyethylene Acetabular<br>Components |
| Device Common Name: | Polyethylene Acetabular Inserts |
| Device Classification Reference: | 21 CFR §888.3350, §888.3358 |

# Predicate Device Identification

The subject Osteonics® (Crossfire™) Polyethylene Acetabular Components fabricated from the subject crosslinked polyethylene are substantially equivalent to their identical predicate counterparts fabricated from the current (standard) polyethylene utilized at Osteonics Corp.

# Device Description

Osteonics® Crossfire™ Polyethylene Acetabular Components consist of the following devices: Osteonics® Omnifit® 10° Cup Insert - Series II (2041C); Osteonics® Omnifit® 20° Cup Insert - Series II (2042C); Osteonics® Omnifit® 0° Cup Insert - Series II (2043C); Osteonics® Omnifit® Eccentric 10° Cup Insert (S2301C); Osteonics® Omnifit® Eccentric 20° Cup Insert (S2302C).

#### Intended Use

Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis, post-traumatic 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; and, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

{1}------------------------------------------------

#### Wear Claims

The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850, show a 90% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, and a 9.4mm bearing thickness. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850, show an 88% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850, when evaluated following an accelerated aging cycle. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, a 9.4mm bearing thickness, and were aged under 80°C in air for 14 days. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850, show an 78% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850, when evaluated under abrasive wear conditions. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, and a 9.4mm bearing thickness. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface, a bovine calf serum lubricant, and an abrasive media of bone cement particulate. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

# Statement of Technological Comparison

The intended use, indications, contraindications, and design specifications of the subject components remain identical to their predicate component counterparts. The raw material being utilized in the manufacture of both the subject and predicate devices remains as ultra-high molecular weight polyethylene (UHMWPE) per ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced in order to create a higher crosslinked polyethylene. The safety and effectiveness of this crosslinked polyethylene in acetabular applications, as well as the proposed wear claims, are adequately supported by the substantial equivalence information, materials data and testing results provided within this premarket notification.

{2}------------------------------------------------

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 1998

Ms. Donna S. Wilson Regulatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K974685/S1 Osteonics® Crossfire™ Polyethylene Acetabular Components Requlatory Class: II Product Code: JDI, LWJ and LPH Dated: July 2, 1998 Received: July 7, 1998

Dear Ms. Wilson:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 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 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 .........

{3}------------------------------------------------

#### Page 2 - Ms. Donna S. Wilson

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.

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 qener 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, 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

{4}------------------------------------------------

# 510(k) Number (if known): K974685

#### Device Name: Osteonics® Polyethylene Acetabular Components

#### Indications For Use:

Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows:

- . Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Osteonics® (Crossfire™) Polyethylene Acetabular Components consist of the following devices:

- Osteonics® Omnifit® 10° Cup Insert Series II (2041C) ●
- Osteonics® Omnifit® 20° Cup Insert Series II (2042C) .
- Osteonics® Omnifit® 0° Cup Insert Series II (2043C) .
- Osteonics® Omnifit® Eccentric 10° Cup Insert (S2301C) .
- . Osteonics® Omnifit® Eccentric 20° Cup Insert (S2302C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|--|
| Prescription Use <span></span><br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <span></span> | |
| | | (Optional Format 1-2-96) | |
| | <div> <img alt="signature" src="signature.png"/> </div> (Division Sign-Off)<br>Division of General Restorative Devices<br>510(k) Number | 12974685 | |

{5}------------------------------------------------

#### Page 2 of 2

# Wear Claims:

The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850, show a 90% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, and a 9.4mm bearing thickness. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850, show an 88% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850, when evaluated following an accelerated aging cycle. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, a 9.4mm bearing thickness, and were aged under 80°C in air for 14 days. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

The Osteonics® Crossfire™ Polyethylene Acetabular Inserts, 2041C-2850, show an 78% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850, when evaluated under abrasive wear conditions. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, and a 9.4mm bearing thickness. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface, a bovine calf serum lubricant, and an abrasive media of bone cement particulate. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

Prescription Use
(Per 21 CFR 801.109)

bcalfo