CORAIL

K953111 · Landos, Inc. · LZO · Dec 27, 1996 · Orthopedic

Device Facts

• Record ID: K953111
• Device Name: CORAIL
• Applicant: Landos, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Dec 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CORAIL® Total Hip Prosthesis is designed to restore hip mobility.

Device Story

CORAIL® is a cementless total hip prosthesis system used by orthopedic surgeons to restore hip mobility. The system comprises a titanium alloy femoral stem with hydroxyapatite (HA) coating, featuring vertical and horizontal grooves for rotational and axial stability; femoral heads made of alumina or cobalt chrome; an HA-coated titanium alloy acetabular cup secured with titanium screws; and polyethylene (PE) inserts. The device is implanted during total hip replacement surgery. The HA coating promotes secondary fixation, while the mechanical design provides primary stability. The prosthesis aims to improve patient quality of life by restoring joint function.

Clinical Evidence

Clinical data based on European experience since 1986 with over 38,000 implants. Reported success rates: 98% at 2 years, 97% at 5 years, and 95% at 6 years (Vidalain, J.P., MD, ARTRO Group, 1994).

Technological Characteristics

Cementless total hip prosthesis. Materials: Titanium alloy (femoral stem/acetabular cup), hydroxyapatite (HA) coating, alumina or cobalt chrome (femoral head), polyethylene (inserts). Features: 12/14 morse taper, vertical/horizontal stem grooves, titanium screw fixation for acetabular cup. Single-use.

Indications for Use

Indicated for patients requiring total hip arthroplasty to restore hip mobility.

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

• Omnifit by Osteonics
• Proform HA by Orthomet
• Contour by Depuy
• Osteolock by Howmedica

Submission Summary (Full Text)

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K953111 DEC 27 1996
Landos Inc.
A SUBSIDIARY OF GROUP LANDANGER CAMUS

# 8 - SUMMARY OF SAFETY AND EFFECTIVENESS

| MANUFACTURER
IDENTIFICATION | LANDANGER-LANDOS
Z.I. La Vendue - B.P. 88
52003 Chaumont Cedex France |
| --- | --- |
| ESTABLISHMENT
REGISTRATION NUMBER | 9007981 |
| SPONSOR IDENTIFICATION | Jean-Paul Burtin
C.E.O.
Landos Inc.
301 Lindenwood Drive, Suite One
Malvern, PA 19355
Telephone: [phone]
Fax: [phone] |
| ESTABLISHMENT
REGISTRATION NUMBER | 2530066 |
| OFFICIAL CONTACT
PERSON | Norman F. Estrin, Ph.D., RAC
President
Estrin Consulting Group, Inc.
9109 Copenhaver Drive
Potomac, MD 20854
Telephone: [phone]
Fax: [phone] |
| PROPRIETARY NAME | CORAIL® |
| COMMON NAME | Total Hip Prosthesis |
| CLASSIFICATION NAME
AND REFERENCE | FDA has classified Total Hip Prosthesis in Class II 21 C.F.R.
Section 888.3353. CORAIL® is classified as a cementless
Total Hip Prosthesis. |

Suite 1, 301 Lindenwood Drive • Malvern, PA 19355
Telephone: [phone] • Fax: [phone]
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8 - SUMMARY OF SAFETY AND EFFECTIVENESS

| PRODUCT
CLASSIFICATION CODE | 87 MEH |
| --- | --- |
| PROPOSED REGULATORY
CLASS | Class II |
| PANEL CODE | 87 OR (Orthopaedic) |
| INTENDED USE | The CORAIL® Total Hip Prosthesis is designed to
restore hip mobility. |
| DESCRIPTION | CORAIL® is a single-use, non-cemented, HA-coated
prosthesis. The CORAIL® Total Hip Prosthesis is a
complete set and consists of:
- femoral stem, made of titanium alloy and completely
coated with hydroxyapatite, with a 12/14 morse taper;
available with or without collar. It is grooved both
vertically and horizontally to provide stability against
driving in and rotation.
- Alumina or cobalt chrome femoral head
- acetabular cup, made of titanium alloy and coated
with HA. Primary fixation is with two to five titanium
screws, secondary fixation through HA.
- PE inserts available in flat-rim, anti-dislocation and
reorientation. |
| PREDICATE DEVICES | The CORAIL® Total Hip Prosthesis is substantially
equivalent to the Omnifit by Osteonics, the Proform
HA by Orthomet, the Contour by Depuy and the
Osteolock by Howmedica. Like these others, the
CORAIL® is an HA coated titanium alloy with
grooves on the femoral stem. |
| SUMMARY OF CLINICAL DATA | Since its introduction in 1986, over 38,000 implants of
the CORAIL® Total Hip Prosthesis have been
performed in Europe. Success rates show 98% success
after 2 years, 97% after 5 years and a 95% success rate
after 6 years. (Hastings, England, April 15-17, 1994,
Vidalain, J.P., MD, ARTRO Group - France). |

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