(90 days)
The intended 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.
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.
This device is a physical medical device (femoral head) and not an AI/ML powered device, therefore most of the requested information is not applicable. I will provide the information that is available.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in burst load to the predicate device. | The burst load average for both the zirconia and cobalt chrome heads is substantially equivalent to that of the predicate device. |
2. Sample size used for the test set and data provenance
Not applicable. This is a physical device, and the testing described is mechanical, not based on data.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. Ground truth for mechanical properties is typically established through direct measurement and testing, not expert consensus in the clinical sense.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
The ground truth used for mechanical testing like burst load is typically derived from physical measurements and destructive testing of the devices themselves, adhering to established engineering standards for medical implants.
8. The sample size for the training set
Not applicable. This is a physical device, and "training set" is not relevant in this context.
9. How the ground truth for the training set was established
Not applicable.
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CE JUNS
JUN - 5 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
| MANUFACTURER IDENTIFICATION: | Landanger-LandosZ.I. La Vendue BP 8852003 Chaumont FRANCE |
|---|---|
| SPONSOR IDENTIFICATION: | Cheryl HastingsManager, Clinical AffairsDePuy Orthopaedics, Inc.P.O. Box 988Warsaw, 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.
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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.
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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
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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
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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_
§ 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.