(57 days)
Not Found
No
The 510(k) summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device replaces a bearing portion of the acetabulum in total hip arthroplasty, which is a therapeutic intervention aimed at treating hip joint issues.
No
The device, the Osteolock™ Acetabular Cup, is described as a component of a hip joint prosthesis intended for replacement in surgery. Its description focuses on its design and function as a replacement part, not on diagnosing medical conditions.
No
The device description clearly states it is a physical component of a hip joint prosthesis, made of metal and polymer, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a portion of the acetabulum in hip replacement surgery. This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a component of a hip joint prosthesis, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Osteolock™ Acetabular Cup is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
Product codes
LZO, LWJ
Device Description
This device is a component of a hip joint, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented prosthesis.
The titaniam plasma spray coating on the outer aspect of the shell provides a roughened surface texture. This plasma spray coating is not a porous coating and, as such, this cup is intended to be press fit into the acetabulum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabulum (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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
MAY 2 9 1998
510(k) Summary
Proprietary Name: Osteolock™™ Acetabular Cup
Common Name: Acetabular Shell
Classification Name and Reference: CFR 888.3353
This device is a component of a hip joint, semi-constrained, metal/ceramic/polymer, cemented or non-porous uncemented prosthesis.
Proposed Regulatory Class: Class II
Device Product Code: OR(87)LZO
Frank Maas For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 4/17/98
The Osteolock™™ Acetabular Cup has been previously cleared (510(k) 903362) for cemented use in the replacement of the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This submission adds the uncemented use of this device as an additional indication. There are no changes to the design, manufacturing methods or operational principles of the device.
The titaniam plasma spray coating on the outer aspect of the shell provides a roughened surface texture. This plasma spray coating is not a porous coating and, as such, this cup is intended to be press fit into the acetabulum.
Assembly/disassembly testing of the liner from the shell as the characterization of the plasma spray coating was presented in the previous submission.
The substantial equivalence of the Osteolock™™ Cup is based on an equivalence in intended use, materials, design, operational principles, and relative indications and contraindications to the currently marketed Osteolock™™ Acetabular Cup (K903362).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 1998
Mr. Frank Maas Manager, Regulatory Affairs Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K981201 Re : Osteolock™ Acetabular Cup Trade Name: Requlatory Class: II Product Codes: LZO and LWJ Dated: April 2, 1998 Received: April 2, 1998
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 Requlations, 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.
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,
Celia M. Witten, Ph.D.
Celia M. Witten, Ph.D., M.D. 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): 账98 ) 201
Device Name: Osteolock™ Acetabular Cup
Indications for Use:
The Osteolock™ Acetabular Cup is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)
(Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K981201 |
|---|---|
| --------------- | --------- |