(393 days)
None
No
The summary describes a physical medical device (acetabular components for hip replacement) and its material properties and performance in wear simulation. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to resurface the acetabular socket in total hip arthroplasty, which is a therapeutic intervention aimed at restoring function and alleviating symptoms.
No
The device is an implantable component for total hip arthroplasty, specifically an acetabular component designed to resurface the acetabular socket. Its purpose is to replace part of a joint, not to diagnose a condition.
No
The device description clearly indicates that the device is a physical component made of cross-linked polyethylene, intended for use in hip arthroplasty. It describes the material and manufacturing process, which are hardware-related.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "resurface the acetabular socket in cemented or cementless total hip arthroplasty." This describes a surgical implant used within the body.
- Device Description: The description details a physical component made of polyethylene for use in hip replacement surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The Implex Cross-Linked Polyethylene Acetabular Components are intended to be used with the below listed, legally marketed Implex Acetabular Component Replacement Systems to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:
- The Implex HEP (Hedrocel) Acetabular Cup, cemented & cernentless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
- The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
- The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options.
- The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.
Product codes
JDI, LPH
Device Description
Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:
- The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
- The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
- The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10° and 20° face angle options.
- The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.
The raw material being utilized in the manufacture of both the subject and predicate devices remains as direct and sheet compression molded ultrahigh molecular weight polyethylene (UHMWPE) conforming to ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced to create a higher cross-linked polyethylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular socket (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)
Wear Claims:
Implex Cross-Linked Polyethylene Acetabular Components with sheet compression molded GUR 1020 show a 65% reduction in gravimetric wear rate versus the same acetabular components (28 mm/52 mm ID/OD, with polyethylene thickness of 9.5 mm) fabricated from Implex's current sheet compression molded GUR 1020 polyethylene, 47% less than the Charnley 'Gold Standard' (22 mm heads), and 87% less than the Charnley 'Gold Standard' 28 mm heads), (0.1 mm of linear head penetration converted to volumetric wear).
Implex Cross-Linked Polyethylene Acetabular Components with direct compression molded (DCM) GUR 1020 show a 89 % reduction in gravimetric wear rate versus the same acetabular components fabricated from Implex's current direct compression molded GUR 1020 polyethylene, 67 % less than the Charnley 'Gold Standard' (22 mm heads), and 95 % less than the linear head penetration converted to volumetric wear).
All hip wear simulation testing was performed under multiaxial hip joint simulation for 5 million cycles, using a super-finished Implex 28 mm Co-Cr-Mo femoral head articulating counterface, a polyethylene component corresponding to a shell OD of 52 mm, and with bovine calf serum as a lubricant. Polyethylene thickness was 8.2 mm for the tested DCM components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Gravimetric wear rate reduction: 65% (sheet compression molded GUR 1020 vs. current sheet compression molded GUR 1020), 89% (direct compression molded (DCM) GUR 1020 vs. current direct compression molded GUR 1020).
Predicate Device(s)
Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices: 1) The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless 2) The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless 3) The Implex A-230 (beaded) Acetabular Cup System, cemented & cementless The Implex Modular Elliptical Porous Cup System 5) The DePuy Duraloc Acetabular Cup System 6) Osteonics Cross-Fire Acetabular Components
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Implex Corp.
MAR - 1 2000
Cross-Linked Polyethylene Acetabular Components Supplement #3 to K990330
pg 1 of 3
510(k) SUMMARY - Implex Cross-Linked Polyethylene Acetabular Components
- Implex Corp. Submitter Name: Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Contact Person(s): Robert Poggie or John Schalago (201) 818-1800 Phone Number: (201) 818-0567 Fax Number: February 28, 2000 Date Prepared: Implex Cross-Linked Polyethylene Acetabular Device Trade Name: Components Device Common Name: Polyethylene Acetabular Components Classification Name: Prosthesis, Hip, Acetabular Component, Cemented, Cementless Predicate Devices: Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices: 1) The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless 2) The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless 3) The Implex A-230 (beaded) Acetabular Cup System, cemented & cementless The Implex Modular Elliptical Porous Cup System 5) The DePuy Duraloc Acetabular Cup System
- 6) Osteonics Cross-Fire Acetabular Components
1
1
K99 0330
510(k) Summary, Continued
Device Description:
Intended Use:
Wear Claims:
Implex Cross-Linked Polyethylene Acetabular
Components are for use with the following legally
marketed Implex devices with 28 mm femoral heads:
- The Implex HEP (Hedrocel) Acetabular Cup, cemented
& cementless. The permitted OD size is 52 mm and
greater for the 0° face-angle, and OD sizes 50 mm and
greater for the 10 and 20° face-angle options. - The Implex Revision HEP (Hedrocel) Acetabular Cup,
cemented & cementless. The permitted OD size is 52
mm and greater for the 0° face-angle, and OD sizes 50
mm and greater for the 10 and 20° face-angle options. - The Implex A-230 (porous beads) Acetabular Cup
System, cemented & cementless. The permitted OD size
is 52 mm and greater for the 0°, 10° and 20° face angle
options. - The Implex Modular Elliptical Porous Cup. The
permitted OD size is 54 mm and greater for the 0°, 10°
and 20° face angle options.
The Implex Cross-Linked Polyethylene Acetabular
Components are intended to be used with the above
listed, legally marketed Implex Acetabular Component
Replacement Systems to resurface the acetabular socket
in cemented or cementless total hip arthroplasty.
Implex Cross-Linked Polyethylene Acetabular
Components with sheet compression molded GUR
1020 show a 65% reduction in gravimetric wear rate
versus the same acetabular components (28 mm/52
mm ID/OD, with polyethylene thickness of 9.5 mm)
fabricated from Implex's current sheet compression
molded GUR 1020 polyethylene, 47% less than the
Charnley 'Gold Standard' (22 mm heads), and 87% less
than the Charnley 'Gold Standard' 28 mm heads), (0.1
mm of linear head penetration converted to volumetric
wear).
2
Wear Claims:
Pag Sog 3 Cross-Linked Polyethylene Acetabular Implex Components with direct compression molded (DCM) GUR 1020 show a 89 % reduction in gravimetric wear rate versus the same acetabular components fabricated from Implex's current direct compression molded GUR 1020 polyethylene, 67 % less than the Charnley 'Gold Standard' (22 mm heads), and 95 % less than the linear head penetration converted to volumetric wear).
All hip wear simulation testing was performed under multiaxial hip joint simulation for 5 million cycles, using a super-finished Implex 28 mm Co-Cr-Mo femoral head articulating counterface, a polyethylene component corresponding to a shell OD of 52 mm, and with bovine calf serum as a lubricant. Polyethylene thickness was 8.2 mm for the tested DCM components.
The results of such in-vitro hip wear simulation tests have not been shown to correlate with clinical wear mechanisms.
The intended use, indications, contraindications, and design specifications of the subject components remain the same as their Implex predicate component counterparts, for the acetabular components and sizes listed above. The raw material being utilized in the manufacture of both the subject and predicate devices remains as direct and sheet compression molded ultrahigh molecular weight polyethylene (UHMWPE) conforming to ASTM F-648. The modifications to the manufacturing process of this polyethylene will be introduced to create a higher cross-linked polyethylene.
The safety and effectiveness of this cross-linked polyethylene in acetabular applications, as well as the proposed wear claims, are supported by the substantial equivalence information, materials data and testing results provided within this Supplement #3 to K990330, the original 510(k) submission (K990330), and Supplements #1 and #2 to K990330.
Cross-Linked Acetabular Implex Polyethylene Components are substantially equivalent to the above identified predicate devices and for the associated component sizes.
Statement of Technological Comparison:
Conclusion:
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2000
Dr. Robert A. Poggie Director of Applied Research Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K990330
Trade Name: Cross-linked Polyethylene Acetabular Components Regulatory Class: II Product Code: JDI and LPH Dated: December 2, 1999 Received: December 3, 1999
Dear Dr. Poggie:
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 control provisions of the Act. The general control 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.
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.
4
Page 2 - Dr. Robert A. Poggie
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 yours,
Neil R.P. Ogden
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number (if known): | K990330 |
|---|---|
| Device Name: | Implex Cross-Linked Polyethylene Acetabular |
| Components | |
| Indications For Use: | The Implex Cross-Linked Polyethylene Acetabular |
| Components are intended to be used with the below | |
| listed, legally marketed Implex Acetabular Component | |
| Replacement Systems to resurface the acetabular | |
| socket in cemented or cementless total hip | |
| arthroplasty. |
Implex Cross-Linked Polyethylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads:
-
- The Implex HEP (Hedrocel) Acetabular Cup, cemented & cernentless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
-
- The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options.
-
- The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options.
-
- The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.
| Concurrence of CDRH; Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use
| (Per 21 CFR 801.109) | N/A |
|---|---|
| OR... | |
| No | |
| Over-The-Counter Use | |
| No | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990330 |
| (Optional Format 1-2-96) |
-8-
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