(63 days)
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.
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the System 12® and Series II™ X3™ Acetabular Inserts:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a table format. Instead, it relies on demonstrating equivalence to predicate devices through various testing and analysis methods. The summary indicates that "A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices."
The reported "performance" is implicitly that the device meets the safety and effectiveness standards for hip replacement implants due to its substantial equivalence to the predicate devices.
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Equivalence to Predicate Device | Not explicitly quantified, but generally implies similar safety and effectiveness. | "A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices." |
| Material Properties | Not explicitly quantified (e.g., tensile strength, fatigue strength). | "Testing and analysis include material properties characterization..." |
| Wear | Not explicitly quantified (e.g., wear rate in mm³/million cycles). | "...wear testing..." |
| Disassembly Force | Not explicitly quantified (e.g., minimum force to separate components). | "...disassembly force evaluation..." |
| Contact Stresses | Not explicitly quantified (e.g., maximum contact pressure, stress distribution). | "...finite element modeling of contact stresses." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The submission describes testing conducted (material properties, wear, disassembly, finite element modeling), but it does not specify the sample sizes for these tests or the provenance of any data used (e.g., country of origin, retrospective/prospective). This is common for predicate device submissions, which often rely on laboratory testing rather than clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in the context of this submission. The "ground truth" for this medical device (an acetabular insert) is not established through expert clinical evaluation of images or patient outcomes in the same way an AI diagnostic device would be. Instead, the "truth" is established through engineering and material science testing against established standards and predicate device performance.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review processes, typically for diagnostic or prognostic devices where there's a need to reach consensus on uncertain cases. For an implantable device like this, the "truth" is determined by objective physical and mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. This is an implantable medical device, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone" algorithm performance is not a concept related to this submission.
7. The Type of Ground Truth Used
The "ground truth" for this device is established primarily through engineering and material science testing against established performance specifications and comparison to predicate devices. This includes:
- Material properties characterization: Demonstrating the material (sequentially crosslinked and annealed polyethylene) meets expected mechanical, chemical, and biological properties.
- Wear testing: Simulating physiological loading and motion conditions to quantify wear rates, comparing them to predicate devices and industry standards.
- Disassembly force evaluation: Measuring the force required to dislodge the insert from its shell, ensuring adequate retention.
- Finite element modeling of contact stresses: Performing computational simulations to predict stress distribution under various loads, demonstrating acceptable stress levels and comparison to predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. Medical device submissions for physical implants, particularly those demonstrating substantial equivalence through laboratory testing, do not typically involve "training sets" in the sense of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. The concept of a "training set" and establishing its "ground truth" pertains to machine learning and AI, which are not involved in the design or testing of this physical implant as described.
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System 12® and Series II™ X3™ Acetabular Inserts
510(k) Premarket Notification
Summary of Safety and Effectiveness
| DEC 2 2005 | |
|---|---|
| Contact Person: | Karen AriemmaSenior Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430(201) 831-5718(201) 831-6038 (FAX) |
| Date: | November 29, 2005 |
| Device: | System 12® X3™ Acetabular InsertsSeries II™ X3™ Acetabular Inserts |
| Classification: | Prosthesis Hip, Semi-Constrained, Porous Coated, Uncementedprosthesis: 21 CFR §888.3358Hip Joint Metal/Ceramic/Polymer Semi-constrained cemented ornonporous uncemented prosthesis: 21 CFR §888.3353Hip 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
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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.
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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.
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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.
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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
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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
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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 |
|---|---|
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| Page | 2 of 2 |
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§ 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.