(280 days)
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No
The summary describes a hip implant component and its manufacturing process, with no mention of AI or ML.
Yes
The device is an acetabular insert used in total hip arthroplasty, which is a medical procedure to treat a condition (e.g., diseased hip joint) and restore function, hence qualifying it as a therapeutic device.
No
Explanation: This device is an acetabular insert for total hip replacement, which is a prosthetic implant, not a diagnostic tool. Its purpose is to function as a bearing surface in the hip joint, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly details a physical implant (acetabular inserts made of UHMWPE) and its manufacturing process, with no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "primary or revision total hip arthroplasty," which is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device is an "acetabular insert," a component of a hip implant. It is made of UHMWPE and is designed to be implanted in the hip joint.
- Anatomical Site: The anatomical site is the "hip."
- Performance Studies: The performance studies described involve "hip wear simulator" testing, which assesses the mechanical properties and wear characteristics of the implant component.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is an implantable medical device used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JWH, JDI
Device Description
The purpose of this submission is to describe an additional style of System 12® acetabular Inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® If process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The acetabular insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The System 12® Acetabular Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.
These System 12® inserts are identical in design to the previously cleared System 12® inserts: they are available in a range of outer diameter sizes to mate with the respective acetabular shell, and 22.0, 22.2, 26, 28, and 32mm inner diameters to mate with Howmedica femoral heads. These inserts are available in a neutral, 10°, and 15° hooded design. The locking mechanism of this style of acetabular insert is identical to the previously released System 12® acetabular inserts.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed in accordance with the draft FDA guidance on UHMWPE.
Key results:
- Duration® II products meet all ASTM F 648 specified standards.
- Duration® II products have no detectable oxidation as measured by FTIR up to 30 days of accelerated aging at 80° C in air.
- Duration® II products have a higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
- Duration® II has a lower tensile modulus than air irradiated UHMWPE. This lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.
- No free radicals are detected in the Duration® II material when analyzed by the ESR technique of the final product.
- Duration® II has a lower wear rate, as measured by hip wear simulator than air irradiated UHMWPE (an average total wear of 198.60 ± 31.9 mm³ instead of 310 ± 40.8 mm³). Testing was performed in a multiaxial hip joint simulator for five million cycles using a 32 mm CoCr head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K980926
DEC 16 1998
510(k) Summary
Duration® II System 12® Acetabular Inserts - Ethylene Oxide Sterilization Device:
The purpose of this submission is to describe an additional style of System 12® acetabular Inserts which are stabilized/sterilized using a process called Duration® II Stabilization. The purpose of the Duration® If process is to crosslink all of the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. During this radiation/stabilization period, the UHMWPE is exposed to a very low oxygen concentration. The stabilized rod stock is then machined to its final configuration. The acetabular insert is packaged in air, and terminally sterilized by the ethylene oxide sterilization process. The System 12® Acetabular Inserts produced by this method conform to the requirements for Ultra High Molecular Weight Polyethylene specified in ASTM Specification F-648, and the FDA guidance document on UHMWPE used in Bearing Surfaces for Orthopedic Devices.
The intended use of this additional style of System 12® acetabular inserts is identical to that of previously released System 12® inserts: they are intended to be used with Osteolock/Vitalock acetabular shells in primary or revision total hip arthroplasty.
These System 12® inserts are identical in design to the previously cleared System 12® inserts: they are available in a range of outer diameter sizes to mate with the respective acetabular shell, and 22.0, 22.2, 26, 28, and 32mm inner diameters to mate with Howmedica femoral heads. These inserts are available in a neutral, 10°, and 15° hooded design. The locking mechanism of this style of acetabular insert is identical to the previously released System 12® acetabular inserts.
These inserts are substantially equivalent to the other System 120 acetabular liners which are already in distribution by Howmedica.
Testing was performed in accordance with the draft FDA guidance on UHMWPE.
The following marketing claims will be made for the product:
-
- Duration® II products meet all ASTM F 648 specified standards.
- Duration® II products have no detectable oxidation as measured by FTIR up to 2. 30 days of accelerated aging at 80° C in air.
-
- Duration® II products have a higher gel content (cross-linking) than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
- Duration® II has a lower tensile modulus than air irradiated UHMWPE. This যঁ lower stiffness has demonstrated an increase in contact area and a decrease in contact stress.
1
- No free radicals are detected in the Duration® II material when analyzed by 5. the ESR technique of the final product.
- Duration® II has a lower wear rate, as measured by hip wear simulator than air 6. irradiated UHMWPE (an average total wear of 198.60 ± 31.9 mm³ instead of 310 ± 40.8 mm³). Testing was performed in a multiaxial hip joint simulator for five million cycles using a 32 mm CoCr head articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Osteonics 359 Veterans Boulevard Rutherford, NJ 07070 (201) 507-7875
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1998
Ms. Margaret Crowe Manager, Requlatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re : K980925 Duration® II Tibial Inserts - EtO Trade Name: Sterilization K980926 Duration® II Acetabular Components - EtO Trade Name: Sterilization Requlatory Class: II Product Codes: JWH and JDI Dated: October 7, 1998 Received: October 8, 1998
Dear Ms. Crowe:
We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturinq Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to
3
Paqe 2 - Ms. Margaret Crowe
In addition, FDA may publish further announcements action. concerning your devices 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 requlations.
This letter will allow you to beqin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (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 devices, 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 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,
lia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosures
4
Indications for Use
510(k) Number (if known): K980926
Device Name: Duration® II System 12® Acetabular Inserts, Ethylene Oxide Sterilization
Indications for Use:
The intended use of this additional style of System 12® acetabular inserts is identival The Intention use of this additional or to of of of of of of the need with to that of provided foremously of evision total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)
Division Sign Org.
eneral Restorative Devic