(111 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a prosthetic femoral head, with no mention of AI or ML.
Yes
The device is a prosthetic replacement for the femoral head used in hip prostheses to treat degenerative joint diseases and fractures, which are therapeutic interventions.
No
The provided text describes a prosthetic device (femoral head replacement) used for treatment, not for diagnosing a condition. It focuses on mechanical properties and indications for use as a replacement part in a surgical procedure.
No
The device description clearly states it is a physical alumina head made of Biolox forte alumina, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the femoral head in a hip prosthesis. This is a device used in vivo (within the body) for structural support and function.
- Device Description: The description details the material (alumina) and physical characteristics (size, taper, offset) of a prosthetic component.
- Performance Studies: The performance studies described are mechanical tests (fatigue, compression, extraction force) relevant to the structural integrity and function of an implant, not diagnostic performance.
- Anatomical Site: The anatomical site is the femoral head and hip joint, which are parts of the body, not biological samples being tested in vitro.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head.
The alumina head can only be used with polvethylene inserts.
This prothesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where other devices or treatments have failed, and congenital dislocation, femoral neck hip, trochanteric fractures, traumatic arthritis, fused and capital diastrophic variant, slipped epiphysis, non-union.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO
Device Description
Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ASTM F 6474 standard.
Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral head, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To evaluate the safety and effectiveness of our Alumina heads, we have made two series of tests:
- Fatigue test and static compression test to rupture in the first series, and
- Fallgue lest and static compression test at 2000 N and measurement of the head extraction a force in the second series.
All the results were in compliance with the requirements set forth by the FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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NOV 1 7 2004
K042035 (pg 1 of 2)
S. rue Nobel ZI. DE KERNEVEZ 29000 QUIMPER FRANCE Tél : 02 98 55 68 95 Fax : 02 98 53 42 13
510 (K) SUMMARY OF SAFETY AND EFFECTIVENESS ALUMINA HEADS
SPONSOR IDENTIFICATION:
Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: (33) 2.98.55.68.95 Fax: (33) 2.98.53.42.13
ESTABLISHMENT REGISTRATION NUMBER: 3003898228
OFFICIAL CONTACT PERSON: Christine QUENDEZ Regulatory Affairs Manager E-mail: fhi.rd@wanadoo.fr
DATE PREPARED:
JULY 10th, 2004
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DEVICE TRADE NAME: DEVICE COMMON NAME: CLASSIFICATION NAME:
ALUMINA HEADS
Ceramic Femoral Head
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
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Class II REGULATORY CLASS: DEVICE PRODUCT CODE: 87 LZO PANEL CODE: 21 CFR 888.3353
DEVICE DESCRIPTION:
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Alumina heads are made of Biolox forte alumina (trademark of CERAMTEC) according to ASTM F 6474 standard.
Alumina heads have a 12/14 cone and are available in two diameters: 28mm and 32mm, with three offsets: -3.5; 0; +3.5.
INDICATIONS FOR USE:
Prosthetic replacement of the femoral head associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter compatible with that of the head.
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1
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PREDICATE DEVICES:
PREDICATE DEVICES:
Numerous alumina heads made of Biolox forte have been cleared three predicate devices based Numerous alumina neads made of Diolox Introl have selected three predicate devices based
by the Food and Drug Administration (FDA). We have second secures by the Food and Drug Administration (1 ce manufacturing and design features.
These predicate devices are:
- esc predicate de vices are:
Apex Modular Alumina Femoral Head (K012918), Apex Surgical - - Apex Modular Alumina Femoral Head (1167877777777777777787777787), Smith & Nephew -
- Diolox Authma Coramic Head Prosthesis (K990261), Plus Orthopedics -
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
COMPARISON OF TECHNODOOTCAD Crand substantial similar indications for use as the Our alumina neads nave the same mended as and of the same material (Biolox forte), are available in similar diameters and lengths, with similar designs.
similar diameters and lengths, whill shinks accepts.
Performance tests were performed. Our proposed devices and the predicate devices were found to have results in compliance with the selected standard.
MATERIAL CHARACTERISTICS:
We have followed the FDA's guideline: "Guidance document for the preparation of prematerial we have for ceramic ball hip systems" dated January 10, 1995 to compare it our material notifications for ceraint ban mp 35stems - attest remairements. Our alumina heads reach all the requirements set up in this guidance document.
PERFORMANCES:
PERFORMANCES:
To evaluate the safety and effectiveness of our Alumina heads, we have made two series of tests:
- Fatigue test and static compression test to rupture in the first series, and -
- Fallgue lest and static compression test at 2000 N and measurement of the head extraction a force in the second series.
All the results were in compliance with the requirements set forth by the FDA.
All the results were in comphance must the specified materials. Processing controls, quality NISK to nearth have bool addressed ation for a
CONCLUSION:
CONCEON.
All these elements show the safety and effectiveness of our product. Our Alumina heads are All these elements show the selected predicate device in terms of intended use, material. safety and effectiveness.
2
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 17 2004
Ms. Christine Quendez Regulatory Affairs Manager Fournitures Hospitalieres Industries ZI de Kernevez 6 rue Nobel 29000 Quimper France
Received: November 1, 2004
Re: K042035
Trade/Device Name: Alumina heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: II Product Code: LZO Dated: November 1, 2004
Dear Quendez:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Christine Quendez
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark H. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Alumina Heads
Prosthetic replacement of the femoral head
associated with a hip prosthesis having a taper compatible with the head taper, and with a prosthetic acetabulum having an inside diameter
The alumina head can only be used with
This prothesis may be used for degenerative joint disease such as osteoarthritis and avascular necrosis, correction of functional deformity, rheumatoid arthritis, revision procedure where
congenital dislocation, femoral neck
trochanteric fractures, traumatic arthritis, fused
diastrophic variant, slipped
compatible with that of the head.
polvethylene inserts.
other devices or
epiphysis, non-union.
14042035
Indications for Use:
R. Mark A. Milkersen
Division Sign-Off
Division of General, Restorative, and Nearological Devices
516(e) Number K042035
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
hip,
Over the counter Use (21 CFR 801 Subpart C)
treatments have failed,
and
capital
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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