(65 days)
Not Found
No
The 510(k) summary describes a mechanical implant (acetabular cup liners) and its intended use in hip replacement surgery. There is no mention of AI, ML, image processing, or any software-driven functionality that would suggest the use of these technologies. The performance studies are nonclinical mechanical tests.
Yes
The device is a component of a total hip replacement system, indicated for use in conditions that cause severe pain and/or disability in the hip joint, with the intention to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation. These are therapeutic effects.
No
The device is an orthopedic implant for total hip replacement procedures, not a tool for diagnosing medical conditions.
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.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged hip joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical implant made of materials like UHMWPE and titanium alloy, designed to be surgically placed in the hip.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / 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.
Intended 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.
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 four additional sizes 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, Acetabular socket
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)
Nonclinical Testing:
Nonclinical testing was provided, including push-out, torque, impingement and high angle fatigue testing. This testing and an evaluation of the device design and geometry demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as the predicate.
Clinical Testing:
No clinical testing was required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K102423 PG. 1/2
510(k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
OCT 2 9 2010
, t
NAME OF SPONSOR: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive
510(K) CONTACT:
DATE PREPARED:
PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION AND REGULATION:
Warsaw, Indiana 46582 Establishment Registration Number: 1818910 Brandon Hipsher, MBA RAC
Manager. Regulatory Affairs Telephone: (574) 372-7465 Facsimile: (574) 371-4987 Electronic Mail: bhipsher@its.jnj.com
September 21, 2010
DePuy Pinnacle® AltrX™ Acetabular Liners
Polyethylene Acetabular Cup Liner
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal, semi-constrained, porouscoated, uncemented prosthesis (LPH)
Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis (LZO)
DEVICE PRODUCT CODE AND LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented DESCRIPTION: LZO: Prosthesis. Hip. Semi-Constrained, Metal/Ceramic/Polymer. Cemented or Non-Porous, Uncemented
DePuy Pinnacle AltrX Acetabular Liners PREDICATE DEVICES (K072963, cleared January 9, 2008)
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 four additional sizes of the predicate acetabular liners.
1
INDICATIONS AND INTENDED USE:
Indications:
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.
Intended 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.
Summary of Technologies/Substantial Equivalence:
The substantial equivalence of the subject DePuy Pinnacle AltrX Acetabular Liners is demonstrated by the similarities in intended use, indications for use, design, materials and performance as compared to the predicate device. The additional sizes do not present new issues of safety or effectiveness.
Nonclinical Testing:
Nonclinical testing was provided, including push-out, torque, impingement and high angle fatigue testing. This testing and an evaluation of the device design and geometry demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as the predicate.
Clinical Testing:
No clinical testing was required to demonstrate substantial equivalence.
Conclusion:
The subject DePuy Pinnacle AltrX Acetabular Liners are substantially equivalent to the predicate device identified in this premarket notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with healthcare, with three diagonal lines representing the branches of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Brandon Hipsher, MBA RAC Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
OCT 2 9 2010
Re: K102423
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 prothesis Regulatory Class: II Product Code: LPH, LZO Dated: September 28, 2010
Received? September 29, 2010
Dear Mr. Hipsher:
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
3
Page 2 - Brandon Hipsher, MBA RAC
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark A. Millbern
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
OCT 2 9 2010
K102423 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:
- l. 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.
Prescription Use X Over-The-Counter Use 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.)
Suta
(Division Sign-off) for mxm
Division of Surgica!, Orthopedic, and Restorative Devices
510(k) Number K102423