(543 days)
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No
The description focuses on the materials and mechanical design of a hip prosthesis, with no mention of AI or ML.
Yes
The device is a total hip prosthesis designed to restore hip mobility, which is a therapeutic function.
No
The device, CORAIL® Total Hip Prosthesis, is designed to restore hip mobility by replacing hip components, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical implantable medical device consisting of a femoral stem, femoral head, acetabular cup, and PE inserts, all made of various materials like titanium alloy, hydroxyapatite, alumina, cobalt chrome, and polyethylene. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The CORAIL® Total Hip Prosthesis is an implantable medical device designed to be surgically placed inside the body to restore hip function. It is a physical component that replaces damaged parts of the hip joint.
- Intended Use: The intended use is to "restore hip mobility," which is achieved through surgical implantation, not through testing bodily samples.
The description clearly indicates a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The CORAIL® Total Hip Prosthesis is designed to restore hip mobility.
Product codes (comma separated list FDA assigned to the subject device)
87 MEH
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows a logo with a stylized letter "L" inside a circle. The letter "L" is formed by two thick, parallel lines that slant diagonally upwards to the right. The circle is incomplete, with a break at the top where the letter "L" intersects it. The logo is black and white, with the letter and circle being black against a white background.
K95311
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 | lean-Paul Burtin
C.E.O.
Landos Inc.
301 Lindenwood Drive, Suite One
Malvern, PA 19355
Telephone:
(610) 640-3177
ax: |
| ESTABLISHMENT REGISTRATION NUMBER | 2530066 |
| OFFICIAL CONTACT
PERSON | Norman F. Estrin, Ph.D., RAC
President
Estrin Consulting Group, Inc.
9109 Copenhaver Drive
Potomac, MD 20854
301) 279-2899
Telephone:
301) 294-0126
Fax: |
| PROPRIETARY NAME | CORAIL® |
| COMMON NAME | Total Hip Prosthesis |
| CLASSIFICATION NAME
AND REFERENCE | FDA has classified Total Hip Prosthesis in Class II 21 C.F.
Section 888.3353. CORAIL® is classified as a cementless
Total Hip Prosthesis. |
Suite 1, 301 Lindenwood Drive • Malvern, PA 19355 Telephone: 610-640-3170 • Fax: 610-640-3177
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1
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. | |
| CORAIL® is a single-use, non-cemented, HA-coated | |
| prosthesis. The CORAIL® Total Hip Prosthesis is a | |
| complete set and consists of: | |
| DESCRIPTION | - 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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