(90 days)
Not Found
No
The 510(k) summary describes a mechanical implant (femoral head) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical properties like burst load.
Yes
The device is a femoral head used to complete the assembly of a hip prosthesis indicated for conditions like arthritis and arthrosis, which are therapeutic interventions.
No
Explanation: The device described is a femoral head, which is a component of a hip prosthesis, used for joint replacement. It is an implantable device used in treatment, not for diagnosing a condition.
No
The device description clearly indicates it is a physical implant (Femoral Head) made of zirconia or cobalt chrome alloy, not software.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a femoral head, which is a component of a hip implant used in surgery to replace a damaged hip joint. It is a physical implant placed inside the body.
- Lack of Diagnostic Function: The device's purpose is to provide structural support and articulation in a hip joint, not to analyze biological samples for diagnostic information.
Therefore, based on the provided information, the 22.2/-4 Femoral Head is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for the 22.2/+4 Femoral Head is to complete the assembly of a Ti-6Al-4V semiconstrained femoral hip stem with a 9/11 Morse-like taper, identical to the taper of the Morphometric Hip, manufactured by Medinov-AMP. The indications for use are arthritis, arthrosis or any joint disease at the hip level, osteosynthesis, failed previous surgery or joint reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI
Device Description
The 22.2/44 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip level
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)
The burst load average for both the ziroma and cobalt chrome heads is substantially equivalent to that of the predicate device.
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
CE JUNS
JUN - 5 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
| MANUFACTURER IDENTIFICATION: | Landanger-Landos
Z.I. La Vendue BP 88
52003 Chaumont FRANCE |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| SPONSOR IDENTIFICATION: | Cheryl Hastings
Manager, Clinical Affairs
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw, IN 46581-0988 |
| ESTABLISHMENT REGISTRATION NUMBER: | 1818910 |
| PROPRIETARY NAME: | 22.2/+4mm Femoral Heads |
| PRODUCT CLASSIFICATION CODE: | 87 LZO |
| PROPOSED REGULATORY CLASS: | Class II |
| PREDICATE DEVICES: | Morphometric Total Hip Prosthesis
(K935185) |
| DESCRIPTION: | |
The 22.2/44 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy.
INDICATIONS AND INTENDED USE:
The intended use for the 22.2/74 Femoral Head is to complete the assembly of a Ti-6Al-4V semiconstrained femoral hip stem with a 9/11 Morse-like taper, identical to the taper of the Morphometric Hip, manufactured by Medinov-AMP. The indications for use are arthritis, arthrosis or any joint disease at the hip level, osteosynthesis, failed previous surgery or joint reconstruction.
SUMMARY OF TESTING DATA:
The burst load average for both the ziroma and cobalt chrome heads is substantially equivalent to that of the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 1997
Ms. Cheryl-Hastings --Manager, Clinical Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K970846 22.2/+4 Femoral Head (Co-Cr Alloy or Zirconia) for use with Morphometric Hip Stem K935185 Requlatory Class: II Product Codes: LZO and JDI Dated: March 5, 1997 Received: March 7, 1997
Dear Ms. Hastings:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation that the package insert must reflect that the Zirconia Ceramic Femoral Heads are to be used only with Ti-6Al-4V Morphometric hip stems with the 5°43'30"-0-5' Morse taper trunnions.
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.
2
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. 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 regulation (21 CFR Part 801 and additionally 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" (21 CFR 807,97). Other general information on your responsibilities under the Act may be
3
Page 3 - Ms. Cheryl Hastings
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
4
17:31
23219 267 7098
.
THE SERI
0002
510(k) Number (if known) K970846
Device Name 222/44 Femoral Head
Indications for Use:
06/02/97
The imended use for the 22.2/-4 Femoral Head is to complete the assembly of a Ti-6Al-4V semicanus and I he mended tise for the 22.27-4 rendral to the tapen of the Morphonetic Hip, manufactures by Medinov-AMP. The indications for use are artintis, arthrosis or any joint disease at the hip level, of wromans is, failed previous surgery or joint reconstruction.
Concurrence of CDRH, Office of Device Evaluation
(Division)
Division Number K970846
Prescription Use X
Over-The Counter Use_