(171 days)
No
The document describes a mechanical implant (acetabular cup liners) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant used in total hip replacement procedures to alleviate pain and disability caused by various joint conditions, directly addressing a health problem.
No
Explanation: The document states that the device is a component of a total hip replacement system, indicated for replacing the natural articular surface of the hip joint. Its function is to provide articulation within a prosthetic joint, not to diagnose medical conditions or provide information for diagnosis.
No
The device description clearly states the device is manufactured from ultra high molecular weight polyethylene (UHMWPE) and locks into a titanium alloy shell, indicating it is a physical implant, not software.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the DePuy Pinnacle AltrX Acetabular Cup Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement procedures. This is a surgical implant used directly within the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
Therefore, based on the provided information, the DePuy Pinnacle AltrX Acetabular Cup Liners are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject liners are intended to be used with the DePuy Pinnacle metal acetabular shells and DePuy metal or ceramic femoral heads to resurface the acetabular socket in cementless total hip arthroplasty. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to support the components.
The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.
Product codes
LPH, LZO
Device Description
The DePuy Pinnacle ALTRX Acetabular Liners are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent additional sizes and style combinations of the predicate acetabular liners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing, including Impingement, High Angle Fatigue, Push-out and Torque-out testing demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as a legally marketed device. Therefore, the subject device is substantially equivalent to the predicate device.
No clinical tests were conducted to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
MAR 1 0 2014
Section 5: 510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics |
| Address | 700 Orthopaedic Drive |
| Warsaw, IN 46582 | |
| Phone number | 574-372-7745 |
| Fax number | 574-371-4987 |
| Establishment Registration | |
| Number | 1818910 |
| Name of contact person | Megan Burns |
| Date prepared | February 14, 2014 |
| Name of device | |
| Trade or proprietary name | DePuy Pinnacle ALTRX Acetabular Liners |
| Common or usual name | Polyethylene Acetabular Cup Liner |
| Classification name | Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented |
| Class | II |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3358: Hip joint metal/polymer/metal, semi-constrained, |
| porous-coated, uncemented prosthesis | |
| 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained | |
| cemented or non-porous uncemented prosthesis | |
| Product Code(s) | LPH, LZO |
| Legally marketed device(s) to | |
| which equivalence is claimed | DePuy Pinnacle ALTRX Acetabular Liners |
| (K102423, cleared October 29, 2010) | |
| Reason for 510(k) submission | Line extension |
| Device description | The DePuy Pinnacle ALTRX Acetabular Liners are part of a modular |
| system designed to replace the natural articular surface of the hip joint | |
| in total hip replacement. The liner is manufactured from ultra high | |
| molecular weight polyethylene (UHMWPE), which locks into a porous | |
| coated, hemispherical outer shell component manufactured from | |
| titanium alloy (Ti-6Al-4V). The liner component articulates with a | |
| metal or ceramic femoral head of an appropriate diameter. The subject | |
| devices represent additional sizes and style combinations of the | |
| predicate acetabular liners. | |
| Intended use of | |
| the device | The subject liners are intended to be used with the DePuy Pinnacle metal |
| acetabular shells and DePuy metal or ceramic femoral heads to resurface the | |
| acetabular socket in cementless total hip arthroplasty. Total hip arthroplasty is | |
| intended to provide increased patient mobility and reduce pain by replacing the | |
| damaged hip joint articulation in patients where there is evidence of sufficient | |
| sound bone to support the components. | |
| Indications for use | The DePuy Pinnacle ALTRX Acetabular Cup Liners are indicated for use in |
| total hip replacement procedures. |
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic
arthritis, rheumatoid arthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery, including joint reconstruction, internal
fixation, arthrodesis, hemiarthroplasty, surface replacement
arthroplasty, or total hip replacement. - Certain cases of ankylosis.
The Pinnacle ALTRX Acetabular Cup Liners are indicated for use with
Pinnacle Acetabular Cups in cementless applications. |
1
2
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE
| COMPARED TO THE PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristics | Subject Device: | ||
| DePuy Pinnacle | |||
| ALTRX | |||
| Acetabular Liners | Predicate Device: | ||
| DePuy Pinnacle | |||
| ALTRX Acetabular | |||
| Liners | |||
| (K102423 and | |||
| K072963) | Reference Device: | ||
| DePuy Pinnacle | |||
| Marathon Acetabular | |||
| Liners (K033273 and | |||
| (K033338) | |||
| Intended Use | Total Hip Arthroplasty | Same | Same |
| Material | UHMWPE, | ||
| GUR 1020 | Same | UHMWPE, | |
| GUR 1050 | |||
| Fixation | Uncemented | Same | Same |
| Compatible | |||
| Acetabular Shell | |||
| Diameters | 52-76 mm | 44-76 mm | 38-76mm |
| Compatible | |||
| Femoral Head | |||
| Diameters | 28, 32, 36, and 40 mm | 28, 32, 36, 40, 44, and 48 | |
| mm | 22, 28, 32, 36, 40, 44, | ||
| and 48 mm | |||
| Minimum cross- | |||
| sectional | |||
| thickness | 3.05 mm | 3.14 mm | 3.25 mm |
| Sterile Method | Gas Plasma | Same | Same |
| Packaging | Double PETG blister | ||
| with Tyvek peel lid | Same | Same | |
| Shelf Life | 5 years | Same | Same |
| PERFORMANCE DATA | |||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | |||
| SUBSTANTIAL EQUIVALENCE | |||
| Non-clinical testing, including Impingement, High Angle Fatigue, Push-out and Torque-out testing |
demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as a legally marketed device. Therefore, the subject device is substantially equivalent to the predicate device.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject DePuy ALTRX Acetabular Liners are substantially equivalent to the predicate DePuy ALTRX Acetabular Liners.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The words are likely part of a document or sign, indicating an affiliation with a public health organization.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2014
DePuy Orthopaedics, Inc Ms. Megan Burns Senior Associate, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K132959
Trade/Device Name: DePuy Pinnacle AltrX Acetabular Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO Dated: December 19, 2013 Received: December 20, 2013
Dear Ms. Burns:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 device complies 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Megan Burns
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use Statement
K132959 510 (k) Number (if known): __
Device Name: DePuy Pinnacle AltrX Acetabular Liners
Indications for Use:
The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.
Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Concurrence of Center for Devices and Radiological Health (CDRH)
Elizabeth & Frank -S
(Division Sign-Off Division of Orthopedic Devices 510(k) Number: K132959