(63 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical implant (acetabular inserts) and focuses on material properties, wear testing, and mechanical performance. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is intended to relieve pain and restriction of motion, consistent with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent a disease or condition.
No
The document describes the device as an acetabular insert used for the "replacement of the bearing and/or articulating surfaces of the acetabulum to relieve pain, and the restriction of motion" as part of a total hip replacement. This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it includes "acetabular inserts," which are physical components used in hip replacement surgery. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "replacement of the bearing and/or articulating surfaces of the acetabulum to relieve pain, and the restriction of motion." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description reinforces this, stating the components are "used for the replacement of the bearing surface of the acetabulum."
- 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. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
This device is a surgical implant used in orthopedic procedures.
N/A
Intended Use / Indications for Use
Intended Use: The Stryker Orthopaedics System 12® X3™ Acetabular insert and Series II™ X3™ Acetabular insert components are single use sterile components intended for the replacement of the bearing and/or articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.
Indications for Use: The System 12® X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Series II™ X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis; revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; and where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Product codes (comma separated list FDA assigned to the subject device)
87 JDI, 87 LPH, 87 LZO, and 87 MEH
Device Description
The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum, 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)
A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. Testing and analysis include material properties characterization, wear testing, disassembly force evaluation, and finite element modeling of contact stresses.
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.
System 12® and Series II™ Hip System Acetabular Inserts
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
§ 888.3350 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
3)
System 12® and Series II™ X3™ Acetabular Inserts
510(k) Premarket Notification
Summary of Safety and Effectiveness
| DEC 2 2005 | |
|---|---|
| Contact Person: | Karen Ariemma |
| Senior Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| (201) 831-5718 | |
| (201) 831-6038 (FAX) | |
| Date: | November 29, 2005 |
| Device: | System 12® X3™ Acetabular Inserts |
| Series II™ X3™ Acetabular Inserts | |
| Classification: | Prosthesis Hip, Semi-Constrained, Porous Coated, Uncemented |
| prosthesis: 21 CFR §888.3358 |
Hip Joint Metal/Ceramic/Polymer Semi-constrained cemented or
nonporous uncemented prosthesis: 21 CFR §888.3353
Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis,
21 CFR §888.3350 |
| Device Product Codes: | 87 JDI, 87 LPH, 87 LZO, and 87 MEH |
| Predicate Devices: | System 12® and Series II™ Hip System Acetabular Inserts |
Intended Use: The Stryker Orthopaedics System 12® X3™ Acetabular insert and Series II™ X3™ Acetabular insert components are single use sterile components intended for the replacement of
1
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System 12® and Series II™ X3™ Acetabular Inserts
510(k) Premarket Notification
the bearing and/or articulating surfaces of the acetabulum to relieve pain, and the restriction of motion.
Indications for Use: The System 12® X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The Series II™ X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows: painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis; revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure; clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results; and where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Proposed Modification: Addition of new polyethylene components of a modified sequentially crosslinked and annealed material which has undergone a STERRAD gas plasma sterilization.
Device Description: The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
2
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System 12® and Series II™ X3™ Acetabular Inserts
510(k) Premarket Notification
Summary of Data: A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. Testing and analysis include material properties characterization, wear testing, disassembly force evaluation, and finite element modeling of contact stresses.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized caduceus symbol, featuring a staff with a snake winding around it.
DEC 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K052748
Trade/Device Name: System 12® X3"" Acetabular Inserts, Series II" X3"" Acetabular Inserts Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LPH, LZO, MEH Dated: September 29, 2005 Received: September 30, 2005
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls approvisions 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 is classified (see above) into either class II (Special Controls) or class III (PMA), they 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CIFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Karen Ariemma
This letter will allow you to begin marketing your devices as described in your Section 510(k) This letter will anow you to begal mainer.ing your antial equivalence of your devices to a legally premarket notification: "The PDT Intering of cation for your device and thus, permits your devices to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrite for your at (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphalled at (21 ) notification" (21CFR Part 807.97). You may obtain Misolanding of reference to prementonibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Z
Sor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: System 12® X3™ Acetabular Inserts
Indications for Use: The System 12® X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use are as follows:
- noninflammatory degenerative joint disease including osteoatrthritis and avascular . necrosis,
- rheumatoid arthritis, .
- correction of functional deformity, .
- revision procedures where other treatments or devices have failed, and .
- treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Over-the-Counter Use X ___ OR Prescription Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of General, Restorative, and Neurologica! Devices
Page 1 of 2
510(k) Number K052748
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Series II™ X3™ Acetabular Inserts
Indications for Use:
The Series II" X3™ Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. Indications for use are as follows:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the acetabulum.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) |
| Division of General, Restorative, and Neurological Devices | |
|---|---|
| ------------------------------------------------------------ | -- |
| 510(k) Number | K052748 |
|---|---|
| --------------- | --------- |
| Page | 2 of 2 |
|---|---|
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