(85 days)
Not Found
Not Found
No
The description focuses on the mechanical properties and design of a hip implant, with no mention of AI or ML.
Yes
The device is intended to replace the acetabulum during total hip arthroplasty, which is a therapeutic intervention.
No
This device is a prosthetic implant (acetabular shell) used in total hip arthroplasty to replace the acetabulum. While its indications for use are related to specific patient conditions which are diagnostic in nature, the device itself is a treatment, not a diagnostic tool that identifies or assesses a medical condition.
No
The device description clearly details a physical, implantable medical device made of metal and polyethylene, intended for surgical implantation during total hip arthroplasty. It does not describe any software component as the primary or sole function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Inter-On Porous Revision Shell is a surgical implant designed to replace the acetabulum (hip socket) during total hip arthroplasty. It is a physical component implanted into the patient's body.
- Intended Use: The intended use clearly states it is for replacing the acetabulum and addresses conditions like degenerative and inflammatory joint diseases. This is a treatment or reconstructive function, not a diagnostic one based on analyzing bodily specimens.
- Device Description: The description details the materials and design of the implant itself, not a system for analyzing biological samples.
While the "Diagnostic indications for use" section might seem confusing, in this context, "diagnostic indications" refers to the conditions for which the device is indicated for use (i.e., the diagnoses that warrant the use of this implant). It does not mean the device itself performs a diagnostic test.
N/A
Intended Use / Indications for Use
The Inter-On Porous Revision Shell with Sealable Screwholes is a porous coated hemispherical shell that is used in conjunction with a snap-in acctabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPE). This device is intended to replace the acetabulum during total hip arthroplasty and may be implanted with or without bone cement. Diagnostic indications for use of this device include:
- revision of a previously implanted acetabular prosthesis;
- patient conditions of noninflammatory degenerative joint disease: e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies: and,
- inflammatory joint disease; e.g., rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The Inter-On Porous Revision Shell with Sealable Screwholes is a hemispherical metal shell that is utilized with a snap-in polyethylene insert. The shell is manufactured from Ti-6Al-4V alloy and coated with Cancellous Structured Titanium™ (CSTT™). The insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is available in standard, hooded and hooded protrusio designs in order to address various clinical situations.
The Revision Shell with Sealable Screwholes is designed for screw application with nine screwholes allowing for screw placement into the illum, ischium and pubis. Furthermore, those screwholes that are not utilized may be plugged after implantation thus limiting the potential for fibrous tissue growth into the shell upon cement extrusion or cement extrusion into the shell upon cemented application. Additionally, if wear of the polyethylene acetabular insert occurs, the hole plugs restrict the debris from migrating through the acetabular shell holes into the acetabulum.
The integrity of the locking mechanism of the Revision Shell was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum
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 integrity of the locking mechanism of the Revision Shell was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.
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.
The Inter-Op Porous Revision Shell with Sealable Screwholes is substantially equivalent to the APR Acetabular Shell (Sulzer Orthopedics Inc.), the S-ROM ZTT II Acetabular Shell with Apical Hole Plug (Johnson & Johnson Orthopedics), the P.F.C. Multi-Holed Porous Coated Acetabular Shell (Johnson & Johnson Orthopedics), the Duraloc 1200 Series Acetabular Cup (DePuy), and, the Trilogy Multi-Holed Shell (Zimmer).
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
MAY 2 2 1997
liba
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Inter-Op™ Porous Revision Shell with Sealable Screwholes.
| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9687 |
|-------------------------|-------------------------------------------------------------------------------------------------------|
| Date: | February 18, 1997 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Hip Joint Metal/Polymer/Metal Semi-constrained
Porous-coated Uncemented Prosthesis, 21CFR 888.3358 |
| Common/Usual Name: | Metal-backed Acetabular Component |
| Trade/Proprietary Name: | Inter-Op™ Porous Revision Shell with Sealable
Screwholes |
PRODUCT DESCRIPTION
The Inter-On Porous Revision Shell with Sealable Screwholes is a hemispherical metal shell that is utilized with a snap-in polyethylene insert. The shell is manufactured from Ti-6Al-4V alloy and coated with Cancellous Structured Titanium™ (CSTT™). The insert is manufactured from ultra-high molecular weight polyethylene (UHMWPE) and is available in standard, hooded and hooded protrusio designs in order to address various clinical situations.
The Revision Shell with Sealable Screwholes is designed for screw application with nine screwholes allowing for screw placement into the illum, ischium and pubis. Furthermore, those screwholes that are not utilized may be plugged after implantation thus limiting the potential for fibrous tissue growth into the shell upon cement extrusion or cement extrusion into the shell upon cemented application. Additionally, if wear of the polyethylene acetabular insert occurs, the hole plugs restrict the debris from migrating through the acetabular shell holes into the acetabulum.
The integrity of the locking mechanism of the Revision Shell was investigated by examining the attachment strength between the acetabular shell and acetabular insert. The strength of the locking mechanism compares favorably to other currently marketed devices.
1
DIAGNOSTIC INDICATIONS
This device is intended to replace the acetabulum during total hip arthroplasty and may be implanted with or without bone cement. Diagnostic indications for use of this device include:
- revision of a previously implanted acetabular prosthesis; 트
- patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, 트 osteoarthritis, or arthritis secondary to a variety of diseases and anomalies; and,
- 발 inflammatory joint disease; e.g., rheumatoid arthritis.
SUBSTANTIAL EQUIVALENCE
The Inter-Op Porous Revision Shell with Sealable Screwholes is substantially equivalent to the APR Acetabular Shell (Sulzer Orthopedics Inc.), the S-ROM ZTT II Acetabular Shell with Apical Hole Plug (Johnson & Johnson Orthopedics), the P.F.C. Multi-Holed Porous Coated Acetabular Shell (Johnson & Johnson Orthopedics), the Duraloc 1200 Series Acetabular Cup (DePuy), and, the Trilogy Multi-Holed Shell (Zimmer).
ు ఒక ప
2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Shavawn Parduhn Requlatory Affairs Associate Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K970705 Re : Inter-Op™ Porous Revision Shell with Sealable Screwholes K970706 Inter-Op™ Porous Protrusio Shell with Sealable Screwholes Regulatory Class: II Product Codes: LPH and LZO Dated: February 25, 1997 Received: February 26, 1997
Dear Mr. Parduhn:
We have reviewed your Section 510(k) notification 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 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 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 requlations affecting your devices 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 devices in the Federal Register. Please note: this response to your
3
Page 2 - Mr. Shavawn Parduhn
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 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 diagnostic 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 one 20gataon" (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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the edge. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Mr. Shavawn Parduhn Regulatory Affairs Associate Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re : K970705
Inter-Op™ Porous Revision Shell with Sealable Screwholes K970706 Inter-Op™ Porous Protrusio Shell with Sealable Screwholes Regulatory Class : II Product Codes: LPH and L20 Dated: February 25, 1997 Received: February 26, 1997
Dear Mr. Parduhn:
We have reviewed your Section 510(k) notification 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 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 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 Regulations, Title 21, Parts 800 to 895. ਜਿ 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 devices in the Federal Register. Please note: this response to your
5
Page 2 - Mr. Shavawn Parduhn
premarket notification submission does not affect any premarker notired have under sections 531 through 542 of obligation you might have the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin 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 warketed produced 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 diagnostic 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
)
Enclosures
6
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): Unknown
Inter-Op™ Porous Revision Shell with Sealable Screwholes Device Name:
Indications For Use:
The Inter-On Porous Revision Shell with Sealable Screwholes is a porous coated hemispherical shell that is used in conjunction with a snap-in acctabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPE). This device is intended to replace the acetabulum during total hip arthroplasty and may be implanted with or without bone cement. Diagnostic indications for use of this device include:
- 해 revision of a previously implanted acetabular prosthesis;
- 비 patient conditions of noninflammatory degenerative joint disease: e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies: and,
- 8 inflammatory joint disease; e.g., rheumatoid arthritis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
on Sign-Off
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative Devices
510(k) Number K970705
Prescription Use
$\times$
OR
Over-The-Counter Use
(Optional Format 1-2-96)