INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS

K993259 · Sulzer Orthopedics, Inc. · LPH · Mar 10, 2000 · Orthopedic

Device Facts

• Record ID: K993259
• Device Name: INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following: - joint destruction resulting from degenerative, posttraumatic or Advanced 1. rheumatoid arthritis. - Fracture or avascular necrosis of the femoral head. 2. - Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, 3. hemiarthroplasty and total hip replacement.

Device Story

Modular total hip prosthesis components; includes Durasul crosslinked polyethylene acetabular inserts and CoCr femoral heads. Used to resurface acetabulum during total hip arthroplasty. Line additions feature decreased polyethylene insert thickness (down to 5mm) and increased diameter of corresponding femoral heads (28, 32, 38, 46mm). Device implanted by orthopedic surgeons in clinical/surgical settings. Provides structural replacement for damaged hip joint surfaces; restores joint function; reduces pain associated with degenerative or inflammatory joint disease. Performance verified via bench testing of wear, contact stress, fatigue, and locking mechanism integrity.

Clinical Evidence

Bench testing only. Testing included wear, contact stress, fatigue, and locking mechanism integrity. No clinical data provided. In vitro wear test results noted as not necessarily correlating with clinical wear mechanisms.

Technological Characteristics

Modular hip prosthesis components. Materials: Durasul crosslinked polyethylene (inserts) and CoCr alloy (femoral heads). Design: Semi-constrained, uncemented, porous-coated. Dimensions: Polyethylene insert thickness reduced to 5mm; femoral head diameters 28, 32, 38, 46mm. Mechanical fixation via acetabular shell interface.

Indications for Use

Indicated for patients with joint destruction due to degenerative, post-traumatic, or advanced rheumatoid arthritis; fracture or avascular necrosis of the femoral head; or failed previous surgeries including osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, or total hip replacement.

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

• Inter-Op Durasul Acetabular Inserts (K983509)

Submission Summary (Full Text)

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K993259
py. #02

## 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for line additions to the Inter-Op™ Durasult. Acetabular components and CoCr Femoral Heads.

| Subinitter: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | September 17, 1999 |
| Contact Person: | Mitchell Dhority, RAC<br>Manager, Regulatory and Clinical Affairs |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous coated<br>uncemented prosthesis, 21 CFR 888.3358 |
| Common/Usual Name: | Total Hip Prosthesis, Semi-constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Inter-Op™ Durasul™ Acetabular Inserts and<br>CoCr Femoral Heads |

#### PRODUCT DESCRIPTION

The Sulzer Orthopedics Inter-Op Durasul Acetabular Inserts were originally cleared via 510(k) K983509. The purpose of the present submission is to gain notice of substantial equivalence for line additions to these previously cleared insert components and corresponding metallic heads. More specifically, this includes decreased thicknesses (down to 5mm) of the previously cleared Inter-Op Durasul Standard Acetabular Insert design for use with 28, 32, 38mm and 46mm CoCr femoral heads.

### SPECIFIC DIAGNOSTIC INDICATIONS

Diagnostic indications for use of this device include:

- patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis.
- those patients with failed previous surgery where pain, deformity, or dysfunction persists. t
- revision of a previously failed arthroplasty. .

#### SUBSTANTIAL EQUIVALENCE

The Inter-Op Durasul Standard Acetabular insert is substantially equivalent and identical in intended use, function, material and general overall design to those products cleared under K983509. These are modular components that are manufactured from the same Durasul crosslinked polyethylene, interface with the same Inter-Op Acetabular Shells and metallic heads and are used to resurface the acetabulum during total hip arthroplasty in the same indications. The main difference is the decreased polyethylene insert thickness (down to 5mm) and increase in diameter of the corresponding head sizes that will be offered.

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K99 3254
,39 r41

Wear, contact stress, fatigue, and locking mechanism integrity testing all indicated that these line additions would perform as intended and similar to legally marketed products. The results of in vitro wear tests have not been shown to correlate with clinical wear mechanisms

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2000

Mr. Mitchell Dhority, RAC Manager, Regulatory and Clinical Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717

Re: K993259

Trade Name: Sulzer Orthopedics Inter-Op™ Durasul™ Acetabular Inserts and CoCr Femoral Heads Regulatory Class: II Product Code: LPH and JDI Dated: January 14, 2000 Received: January 18, 2000

Dear Mr. Dhority:

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 control provisions of the Act. The general control 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 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 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. Mitchell Dhority, RAC

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,

Kinnell Snyer

So James E. Dillard III Acting 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): | K99325-9 |
|---------------------------|----------|
|---------------------------|----------|

Device Name: Inter-Op Durasul Acetabular Components/CoCr Heads - Line Additions

# Indications for Use:

The Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following:

- joint destruction resulting from degenerative, posttraumatic or Advanced 1. rheumatoid arthritis.
- Fracture or avascular necrosis of the femoral head. 2.
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, 3. hemiarthroplasty and total hip replacement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thamel'sayer

(Division Sign-Off) Division of General Restorative Devices
510(k) Number ________________________________________________________________________________________________________________________ 510(k) Number _

**Prescription Use**

OR

Over-the Counter Use

(Optional Format 1-2-96)