PROCOTYL-E ACETABULAR SYSTEM

K043073 · Wrightmedicaltechnologyinc · KWA · May 4, 2005 · Orthopedic

Device Facts

• Record ID: K043073
• Device Name: PROCOTYL-E ACETABULAR SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KWA · Orthopedic
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.

Device Story

PROCOTYL-E Acetabular System; metal acetabular shells, plates, and hooks; designed for uncemented total hip arthroplasty. Features oblong dual hemispherical outer geometry with hemispherical offset to accommodate bone loss; includes eccentric design for screw fixation. Used in conjunction with WMT polyethylene/metal liners and WMT metal/ceramic femoral heads. Implanted by orthopedic surgeons in clinical settings to restore hip function and reduce pain in patients with degenerative joint disease or fractures. Provides stable anchorage via titanium alloy plates and hooks.

Clinical Evidence

No clinical data provided; substantial equivalence supported by materials data and bench testing results.

Technological Characteristics

Components: metal acetabular shells, plates, and hooks. Material: titanium alloy. Design: oblong dual hemispherical outer geometry with hemispherical offset. Fixation: uncemented, porous-coated. Intended for use with WMT polyethylene/metal liners and WMT metal/ceramic femoral heads.

Indications for Use

Indicated for skeletally mature patients requiring total hip arthroplasty for pain relief or improved function due to non-inflammatory/inflammatory degenerative joint disease (e.g., osteoarthritis, rheumatoid arthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), functional deformity, revision of failed devices, or proximal femur fractures (nonunion, femoral neck, trochanteric) unmanageable by other techniques.

Regulatory Classification

Identification

A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).

Submission Summary (Full Text)

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K043073

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MAY - 4 2005

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the PROCOTYLE-E.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

November 5, 2004

Ehab M. Esmail Senior Manager, Regulatory Affairs

#### PROCOTYLE-E

Acetabular Shell

21 CFR 888.3358 Hip joint metal/polymer/metal semi- constrained porous - coated uncemented prosthesis -- Class II

21 CFR 888.3353 Prosthesis, Hip, Semi-Constrained, metal/ ceramic/ polymer, cemented or non-porous uncemented- Class II

21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with uncemented acetabular component prosthesis -- Class III

Device Product Code and Panel Code:

Orthopedics/87/LPH, KWA, LZO

### DEVICE INFORMATION

### A. INTENDED USE

The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; 3.
- 4. revision procedures where other treatments or devices have failed; and,
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5. with head involvement that are unmanageable using other techniques.

Arlington, TN 38002 011.49.4161.745130 Germany

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K043073 2/2

The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylenc and metal Acetabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty.

### B. DEVICE DESCRIPTION

The PROCOTYL-E Acetabular System consists of metal acetabular shells, plates and hooks.

The added design features of the PROCOTYL-E Acetabular Shell are summarized below:

- The PROCOTYL-E Acetabular shell feature an oblong dual hemispherical outer . geometry with a hemispherical offset to accommodate for bone loss.
- Eccentricity and offset are increased to accommodate for bone loss and screw fixation .
- The PROCOTYL-E shell allows use of a wide range of plates, hooks, all of which are . manufactured from titanium alloy, available in various types and sizes, thus guaranteeing a stable and secure anchorage of the shell to enhanced fixation and stability.

### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of the PROCOTYL-E Acetabular Shell are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the PROCOTYL-E Acetabular Shell are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2005

Mr. Ehab M. Esmail Senior Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K043073

Trade/Device Name: PROCOTYL-E Acetabular System Regulation Numbers: 21 CFR 888.3330, 888.3353, 888.3358 Regulation Names: Hip joint metal/metal semi-constrained, with uncemented acetabular component prosthesis, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: III Product Codes: KWA, LZO, LPH Dated: March 25, 2005 Received: March 28, 2005

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2 – Mr. Ehab M. Esmail

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr is issuaires or our device complies with other requirements of the Act that FDA has made a dolorimiation administered by other Federal agencies. You must of ally redital statutes and regarations and limited to: registration and listing (21 Comply with an the rive orequentions)01); good manufacturing practice requirements as set CFK Fart 807), labeling (21 OF R Part 820); and if applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manesing your device of your device to a legally premits that notication. The President 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), please 11 you desire specific aarroliance at [phone]. Also, please note the regulation entitled, Contact the Office of Company of Company of CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerery yours,

Stpt Rlurde

riam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### PROCOTYL-E Acetabular System INDICATIONS STATEMENT

1043073

510(k) Number (if known):

#### Device Name: PROCOTYL-E Acetabular System

Indications For Use:

The PROCOTYL-E Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
- correction of functional deformity; 3.
- revision procedures where other treatments or devices have failed; and, 4-
- treatment of fractures that are unmanageable using other techniques. న్.

The PROCOTYL-E Acetabular System consists of single use components that are intended to accommodate for bone loss. This system is to be used in conjunction with associated WMT polyethylene and metal Acctabular liners articulating with associated WMT metal and ceramic femoral heads as part of an uncemented total hip arthroplasty

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrent (Division Sign-Off)vice Evaluation (ODE) | | | |
|-----------------------------------------------------|--|--|--|
| Division of General, Restorative, | | | |
| and Neurological Devices | | | |

| headquarters<br>Wright Medical Technology, Inc. 5677 Airline Road | 510(k) Number | K043073 |
|-------------------------------------------------------------------|--------------------|-------------|
| Arlington, TN 38002 | 901.867.9971 phone | www.wmt.com |

| international subsidiaries | | | |
|----------------------------|--------------------------|-----------------------------|----------------------------|
| 011.32.2.378.3905 Belgium | 905.826.1600 Canada | 011.33.1.45.13.24.40 France | 011.49.4161.745130 Germany |
| 011.39.0250.678.227 Italy | 011.81.3.3538.0474 Japan | 011.44.1483.721.404 UK | |