(68 days)
Not Found
No
The summary describes a mechanical implant (femoral head) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a metallic femoral head intended for hip arthroplasty, which is a surgical procedure to replace a damaged hip joint. While it treats a condition, it is a prosthetic implant, not a therapeutic device that applies energy or substances to treat disease.
No
The device is an orthopedic implant (femoral head) intended for replacement in hip arthroplasties, not for diagnosing conditions.
No
The device description clearly states it is a metallic femoral head, which is a hardware component intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a metallic femoral head, which is an implantable prosthesis used in hip replacement surgery. It is a physical component inserted into the body.
- Intended Use: The intended use describes the conditions for which the device is used in the hip joint, which is a surgical application, not a diagnostic test performed on a sample.
The information provided describes a medical device used for surgical intervention, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameter for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameter.
Prosthetic replacement of the femoral head associated with hip prosthesis, which cone is compatible with the head's cone and with a prosthetic acetabular cup, whose diameter is compatible with the head.
The ESOP® Co-Cr Femoral Heads are 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 is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
Product codes (comma separated list FDA assigned to the subject device)
LPH
Device Description
The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameter for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
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)
Testings conducted to characterize the materials under defined laboratory conditions are provided to support a finding of substantial equivalence.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
1
| JUN 12 2002 | K021109
page 1 of 2 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510 (K) SUMMARY - Metallic Femoral Head |
| Submitter name: | Fournitures Hospitalières Industrie |
| Submitter adress: | 6 Rue Nobel, Z.I. de Kernevez
QUIMPER, France 29000 |
| Contact person: | Mrs Christine QUENDEZ |
| Phone Number: | +33.2.98.55.68.95 |
| Fax Number: | +33.2.98.53.42.13 |
| Date prepared: | April 5, 2002 |
| Device Trade Name: | Metallic Femoral Head |
| Device common name: | Femoral head |
| Classification name: | Hip joint metal/polymer/metal semi-constrained porous-
coated uncemented prosthesis |
| Predicate Device: | Headloc™ Femoral Head
Primaloc® Cementless Hip System (K953977)
Ortho Development Corporation
Intrinsic® Cementless Total Hip System (K923911)
Ortho Max. Inc.
Exactech AcuMatch Hip System (K010081) |
| Device description: | The Metallic Femoral Heads are intended to be adapted to
special cones machined for this purpose. Femoral head are
available in several diameter for use in full hip or
intermediary replacement. The length of the neck on the
femoral stem can be adjusted by using the heads available
in different insertion depths (short, medium, long and extra-
long collars), and of different diameter. |
| Intended use: | Prosthetic replacement of the femoral head associated with
hip prosthesis, which cone is compatible with the head's
cone and with a prosthetic acetabular cup, whose diameter
is compatible with the head. |
| K021109
page 2 of 2 | |
| Characteristics and
Comparison to Predicate
Devices: | Femoral heads made of chrome cobalt (Ø 28 & 32 mm),
short collar, medium collar long collar & extra-long collar
with cone dimensions 12/14, 5°43' & 10/12, 6°. The
identified predicate devices have the same intended use,
are made of the same material, have the same size, and
collar + cone dimensions are of the same order of
magnitude. |
| Performance Data: | Testings conducted to characterize the materials under
defined laboratory conditions are provided to support a
finding of substantial equivalence. |
| Conclusion: | The Metallic Femoral Heads are substantially equivalent to
predicate devices in terms of intended use, safety, and
effectiveness. |
Device Technological
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
JUN 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fournitures Hospitalières Industrie c/o Dr. Andre Weith Director, Pro-Active Healthcare c/o PharmaNet, Inc. 815 Connecticut Avenue NW, Suite 800 Washington, D.C. 20006
Re: K021109
Trade/Device Name: ESOP® Co-Cr Femoral Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: April 5, 2002 Received: April 5, 2002
Dear Dr. Weith:
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 - Dr. Andre Weith
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Mark N. Millenson
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
Sponsor: Pro-Active
510(k) Number (if known):
K02ii09
page 1 of 1
Device Name:
ESOP® Co-Cr Femoral Heads
Indications for Use:
The ESOP® Co-Cr Femoral Heads are 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 is 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) | ||
|---|---|---|
| for | ||
| (Division Sign-Off) | ||
| Division of General, Restorative and Neurological Devices |
| Prescription Use (Per 21 CFR 801.109) | 510(k) NumberK021109OR Over-The-Counter Use | 510(k) Number | K021109 | OR Over-The-Counter Use | |
|---|---|---|---|---|---|
| 510(k) Number | K021109 | ||||
| OR Over-The-Counter Use |
(Optional Format 1-2-96)