(88 days)
Not Found
No
The summary describes a mechanical implant (acetabular shells) and its physical properties, with no mention of software, algorithms, or any terms related to AI or ML.
No
The device is an orthopedic implant for hip reconstruction, not a therapeutic device for treating a condition outside of its reconstructive function.
No
Explanation: The device is an acetabular shell, which is an implant used for reconstruction of the hip joint. Its purpose is therapeutic (replacement) rather than diagnostic (identifying a condition).
No
The device description clearly describes physical components (Acetabular Shells) made of Vitallium® with a mesh ingrowth surface, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty." This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a physical implant (acetabular shells) made of Vitallium® for surgical implantation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device does not perform such testing.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Acetabular Shells with Mesh Ingrowth Surface are intended to be used for uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty.
Product codes
JDI, LPH
Device Description
The Acetabular Shells with Mesh Ingrowth surface are a series of Vitallium® acetabular components intended for the primary reconstruction of the acetabulum during total hip arthroplasty. These components are designed with a mesh ingrowth surface that is integrally cast in to the shell substrate. The shells are available in a range of outer diameters to accommodate various anatomical requirements. These shells are available in four styles; a solid back, a solid back with visualization hole, a cluster shell with screw holes, and a shell that is pre-assembled with the plastic insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular portion of the hip joint
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
Mechanical as well as Biological testing was presented to demonstrate the equivalence of the cast mesh surface to that of a sintered beaded porous coating.
Key Metrics
Not Found
Predicate Device(s)
K930223, K935731, K952397, K933102, K954698
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K973/63
510(k) Summary
NOV 2 1 1997
Proprietary Name: Acetabular Shells with Mesh Ingrowth Surface
Common Name: Modular Acetabular Component
21 CFR 888.3358 Classification Name and Reference: Hip Joint Metal/Polymer/Metal semi-constrained porous coated uncemented prosthesis.
Proposed Regulatory Class: Class II
Device Product Code: JDI
مز-سن
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 8-22-97
The Acetabular Shells with Mesh Ingrowth surface are a series of Vitallium® acetabular components intended for the primary reconstruction of the acetabulum during total hip arthroplasty.
These components are designed with a mesh ingrowth surface that is integrally cast in to the shell substrate. The shells are available in a range of outer diameters to accommodate various anatomical requirements. These shells are available in four styles; a solid back, a solid back with visualization hole, a cluster shell with screw holes, and a shell that is pre-assembled with the plastic insert.
The substantial equivalence of these devices is based on an equivalence in intended use, design, materials, manufacturing methods, and indications and contraindications to Howmedica's Vitalock® Solid Back Shells(K930223, K935731, K952397), Vitalock® Cluster Cup(K933102), and Zimmer's Trilogy™ Acetabular Cup(K954698).
Mechanical as well as Biological testing was presented to demonstrate the equivalence of the cast mesh surface to that of a sintered beaded porous coating.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human profiles are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
K973163 Re: Acetabular Shells with Mesh Ingrowth Surface Trade Name: Requlatory Class: II Product Code: LPH August 22, 1997 Dated: Received: August 25, 1997
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 The general controls provisions of the Act 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 requlation may result in requlatory 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 requlations.
NOV 21 1997
2
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Cola M. Witton, Ph. D., M.
a M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Acetabular Shells with Mesh Ingrowth Surface
Indications for Use:
The Acetabular Shells with Mesh Ingrowth Surface are intended to be used for uncemented, primary reconstruction of the acetabular portion of the hip joint during total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
1
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
tocoolo
(Division Sign-Off) Division of General Restorative Devices 510(k) Number