(455 days)
No Reference Device(s) K/DEN number are listed in the text.
No
The summary describes a mechanical implant and its components, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
This device, a femoral stem for hip arthroplasties, is used to treat degenerative and inflammatory arthritis, trauma, and fractures, which directly addresses disease conditions and restores function, fitting the definition of a therapeutic device.
No
Explanation: The device is a femoral stem (prosthesis) used for replacement of the hip joint in patients with various conditions, not for diagnosing them. It is an implantable medical device.
No
The device description clearly outlines physical components (ceramic head, metaphysary parts, diaphysary parts) and an instrumentation system, indicating it is a hardware medical device, not software-only.
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 and intended use: The provided information clearly describes a femoral stem, which is an implantable medical device used in hip replacement surgery. Its intended use is to treat various conditions affecting the hip joint by replacing the damaged bone.
- Lack of diagnostic activity: The device itself does not perform any diagnostic testing on biological samples. It is a physical implant.
Therefore, based on the provided information, the ESOP® S/C Femoral Stem is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
MEH, LZO
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.
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 metaphys for ease of insertion into the femoral canal; and 7 diaphysary parts in various sizes which are to be screwed into the extremitv of the metaphyseal part.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, Femoral neck
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
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.
Key Metrics
Not Found
Predicate Device(s)
Primaloc® Cementless Hip System (K953977), Intrinsic® Cementless Total Hip System (K923911)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K96 48 78
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 . . .
..
1
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 metaphys for ease
of insertion into the femoral canal; and 7 diaphysary parts
in various sizes which are to be screwed into the extremitv
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. |
2
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 stylized eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1998
Mr. Ben Van der Kooij Director, Europe/USA Pro-Active International Requlatory Agent for Fournitures Hospitalieres c/o Advanced Bioresearch Associates 1700 Rockville Pike, Suite 450 Rockville, Maryland 20852
Re : K964878 ESOP® S/C Femoral Stem Requlatory 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:
-
- 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.
-
- 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.
3
Page 2 - Mr. Ben Van der Kooij
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 A substantially equivalent determination assumes 895. 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 Druq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
4
Page 3 - Mr. Ben Van der Kooij
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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
5
510(k) Number (if known):
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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 2964878 |
| Prescription Use (Per 21 CFR 801.109) | X | OR... | Over-The-Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ------- | ---------------------- |
(Optional Format 1-2-96)