(280 days)
Not Found
Not Found
No
The summary describes a mechanical implant (acetabular inserts) and a sterilization/stabilization process. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on wear rates, which are physical properties, not algorithmic performance.
Yes
The device, an acetabular insert for total hip arthroplasty, is intended to treat a medical condition (damaged hip joint) by replacing a body part, thus providing therapy.
No
The device description indicates that these are "acetabular inserts" used in total hip arthroplasty, which are prosthetic components, not diagnostic tools. Their performance studies focus on wear rates, further confirming their non-diagnostic function.
No
The device description clearly describes physical components (acetabular inserts made of UHMWPE) and manufacturing processes involving sterilization and machining, indicating it is a hardware device, not software-only.
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. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is an "acetabular insert" made of "Ultra High Molecular Weight Polyethylene" and is designed to be used with "acetabular shells." This describes a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on "wear simulation testing," which is relevant to the mechanical performance and longevity of an implant, not its diagnostic accuracy.
IVD devices are specifically designed to perform tests in vitro (outside the body) on specimens derived from the human body. This device is an implant used in vivo (inside the body) for a surgical procedure.
N/A
Intended Use / Indications for Use
The intended use of the additional styles of the System 12®, Omnifit®, & Trident™ acetabular inserts is identical to that of previously released inserts: they are intended to be used with their respective acetabular shells in primary or revision total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LPH
Device Description
The purpose of this submission is to describe additional styles of System 120 Acetabular, Omnifit® and Trident™ Acetabular Inserts which are sterilized/ stabilized using a process called Duration® IV Stabilization. The purpose of the Duration® IV process is to minimize (through crosslinking) the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. The stabilized rod stock is then machined to its final configuration. The components are packaged in air, and terminally sterilized by either Gas Plasma or Ethylene Oxide sterilization. The components 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Testing was performed in accordance with the draft FDA guidance on UHMWPE.
Summary of marketing claims/performance:
- Duration® IV products meet all ASTM F-648 specified standards.
- Duration® IV products have no detectable oxidation as measured by FTIR up to 23 days of accelerated aging at 80℃ in air.
- Duration® IV products have a higher cross-linking density than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
- Duration® IV 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® IV material when analyzed by the ESR technique of the final product.
- Duration® IV has a 91% lower wear rate, as measured by hip wear simulation testing under non-abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere (an average total wear of 22.8 ± 13.7mm² instead of 258.8 ± 39.7 mm3). Testing was performed in a multiaxial hip joint simulator for 5.0 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum used as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
- Duration® IV has a 98% lower wear rate, as measured by hip wear simulation testing under abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere (an average total wear of 2.2 ± 2.2 mm² instead of 89.9 ± 4.0 mm'). Testing was performed in a multiaxial hip joint simulator for 3.5 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum used as a lubricant and PMMA bone cement particles as the abrasive media.. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
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.
Not Found
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
DEC 20 1991
510(k) Summarv
Proprietary Name: Duration® IV Sterilization / Stabilization Process (System 12® Acetabular Inserts, Omnifit® and Trident™ Acetabular Inserts)
Common Name: Modular Acetabular Inserts
Classification Name and Reference: 21 CFR 888.3353 Hip Joint Metal/Ceramic/Polymer, Semi-Constrained Cemented or uncemented prosthesis
Proposed Regulatory Class: Class II
Device Product Code: JDI OR(87)
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Osteonics Corp. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 3/12/99
The purpose of this submission is to describe additional styles of System 120 Acetabular, Omnifit® and Trident™ Acetabular Inserts which are sterilized/ stabilized using a process called Duration® IV Stabilization. The purpose of the Duration® IV process is to minimize (through crosslinking) the free radicals found in the UHMWPE rod stock by exposure to gamma radiation followed by a stabilization process in a heated oven. The stabilized rod stock is then machined to its final configuration. The components are packaged in air, and terminally sterilized by either Gas Plasma or Ethylene Oxide sterilization. The components 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 the additional styles of components referenced above is identical to that of the previously released components. The System 12®, Omnifit®, and Trident™ acetabular inserts are intended to be used with their respective acetabular shells in primary or revision total hip arthroplasty.
Testing was performed in accordance with the draft FDA guidance on UHMWPE.
1
The following marketing claims will be made for the products:
- I. Duration® IV products meet all ASTM F-648 specified standards.
-
- Duration® IV products have no detectable oxidation as measured by FTIR up to 23 days of accelerated aging at 80℃ in air.
-
- Duration® IV products have a higher cross-linking density than air irradiated UHMWPE measured in accordance with modified ASTM D2765-90 standard.
-
- Duration® IV 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.
- న. No free radicals are detected in the Duration® IV material when analyzed by the ESR technique of the final product.
- રં. Duration® IV has a 91% lower wear rate, as measured by hip wear simulation testing under non-abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere (an average total wear of 22.8 ± 13.7mm² instead of 258.8 ± 39.7 mm3). Testing was performed in a multiaxial hip joint simulator for 5.0 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum used as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
-
- Duration® IV has a 98% lower wear rate, as measured by hip wear simulation testing under abrasive conditions, than UHMWPE that is gamma sterilized in an inert atmosphere (an average total wear of 2.2 ± 2.2 mm² instead of 89.9 ± 4.0 mm' ). Testing was performed in a multiaxial hip joint simulator for 3.5 million cycles using a 32 mm CoCr head articulating counterface against a 4.8 mm thickness polyethylene insert with bovine calf serum used as a lubricant and PMMA bone cement particles as the abrasive media.. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
Mr. Frank Maas Manager, Regulatory Affairs Howmedica Osteonics Corporation 359 Veterans Blvd. Rutherford, New Jersey 07070
Re: K990849
Trade Name: Duration IV Sterilization Process (Acetabular Inserts) Regulatory Class: II Product Code: LPH and JDI Dated: September 13, 1999 Received: September 30, 1999
Dear Mr. Maas:
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. 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 (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 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 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.
3
Page 2 - Mr. Frank Maas
This letter will allow you to begin marketing your device as described in your 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 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 obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Neil R.P. Ogden for
James E. Dillard
Acting Division Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K990849 510(k) Number (if known):
System 12®, Omnifit®, & Trident™ Acetabular Inserts Device Name:
Indications for Use:
The intended use of the additional styles of the System 12®, Omnifit®, & Trident™ acetabular inserts is identical to that of previously released inserts: they are intended to be used with their respective acetabular shells in primary or revision total hip arthroplasty.
(Division Sign-Off)
Division of General Restorative Devices K 990849 510(k) Number --
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ 2022 OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)