ESOP S/C FEMORAL STEM

K964878 · Fournitures Hospitalieres · MEH · Mar 5, 1998 · Orthopedic

Device Facts

• Record ID: K964878
• Device Name: ESOP S/C FEMORAL STEM
• Applicant: Fournitures Hospitalieres
• Product Code: MEH · Orthopedic
• Decision Date: Mar 5, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ESOP® S/C Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

Device Story

The ESOP® S/C Femoral Stem is a modular hip prosthesis for cementless implantation. It comprises a ceramic head, metaphysary parts (left/right, various diameters, 10° lateral relief), and diaphysary parts (various sizes) that screw into the metaphyseal component. The device is implanted by a surgeon using a dedicated instrumentation system. It functions via mechanical interlock (press-fit) within the femoral canal. The device is intended to replace the hip joint in patients with arthritis, trauma, or necrosis. It provides a structural replacement for the femoral component of the hip joint, aiming to restore joint function and mobility. The device must be used with the titanium alloy cone of the ESOP® S/C Femoral Stem.

Clinical Evidence

Bench testing only. Data provided to characterize materials, hydroxylapatite coating, and performance characteristics under defined laboratory conditions to support substantial equivalence.

Technological Characteristics

Modular hip prosthesis; ceramic head; titanium alloy cone; metaphysary parts with 10° lateral relief; screw-in diaphysary parts; hydroxylapatite coating; cementless press-fit fixation.

Indications for Use

Indicated for patients with degenerative/inflammatory hip arthritis, trauma, non-acute femoral neck fractures, failed prior hip arthroplasties, or idiopathic avascular necrosis, provided sufficient sound bone exists for prosthesis seating. Intended for cementless application.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Primaloc® Cementless Hip System (K953977)
• Intrinsic® Cementless Total Hip System (K923911)

Submission Summary (Full Text)

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K 964878

510(k) SUMMARY - ESOP® S/C FEMORAL STEM

MAR - 5 1998

| Submitter Name: | Fournitures Hospitalieres
Office Medico Chirurgical International |
| --- | --- |
| Submitter Address: | 6 Rue Nobel, Z.I de Kernevez
Quimper, France 29000 |
| Contact Person: | Christine Quendez |
| Phone Number: | (+33) 98.55.68.95 |
| Fax Number: | (+33) 98.53.42.13 |
| Date Prepared: | December 5, 1996 |
| Device Trade Name: | ESOP® S/C Femoral Stem |
| Device Common Name: | Hip Stem |
| Classification Name: | Prosthesis, Hip, Femoral Component (Metal Stem - Ceramic Head) |
| Predicate Devices: | Primaloc® Cementless Hip System (K953977),
Ortho Development Corporation;

Intrinsic® Cementless Total Hip System (K923911),
Ortho Max, Inc. |
| Device Description: | The ESOP® S/C Femoral Stem consists of a ceramic head, left and right configuration metaphysary parts in various size diameters, and diaphysary parts in various sizes. The ESOP® S/C instrumentation system is utilized for proper implantation of the device. |
| Intended Use: | The ESOP® S/C Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application. |

Continued...

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510(k) Summary (continued)

**Device Technological Characteristics and Comparison to Predicate Devices:**

The ESOP® S/C Femoral stem design includes: 2 ceramic heads with short, medium, or long necks; 10 left and right configuration metaphysary parts in various size diameters with a 10° relief to the lateral side of the metaphysis for ease of insertion into the femoral canal; and 7 diaphysary parts in various sizes which are to be screwed into the extremity of the metaphyseal part. Identified predicate devices have the same intended use and may incorporate some of or all of the above described design features either alone or in combination.

**Performance Data:**

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

**Conclusion:**

The ESOP® S/C Femoral Stem is substantially equivalent to 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

Mr. Ben Van der Kooij
Director, Europe/USA
Pro-Active International
Regulatory Agent for Fournitures Hospitalieres
c/o Advanced Bioresearch Associates
1700 Rockville Pike, Suite 450
Rockville, Maryland 20852

MAR - 5 1998

Re: K964878
ESOP® S/C Femoral Stem
Regulatory Class: II
Product Codes: MEH and LZO
Dated: December 5, 1997
Received: December 5, 1997

Dear Mr. Van der Kooij:

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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations:

1. The package insert must reflect that the ESOP® Femoral Ceramic Heads are to be used only with the titanium alloy cone of the ESOP® S/C Femoral Stem.

2. You may not label or in any way promote these devices for "biological attachment, enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional press-fit hip prosthesis (i.e., mechanical interlock, only).

Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.

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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.

You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.

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. 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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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): K964878

Device Name: ESOP® S/C Femoral Stem

Indications For Use:

The ESOP® S/C Femoral Stem is a device intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)

OR...

Over-The-Counter Use ☐ (Optional Format 1-2-96)

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