(82 days)
Not Found
No
The summary describes a mechanical implant component and its material properties and wear performance, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical implant intended to replace damaged parts of the hip joint in total hip replacement procedures, which is a therapeutic intervention aimed at increasing patient mobility and reducing pain.
No
Explanation: This device is an implantable medical device (acetabular cup liner) used in total hip replacement procedures. Its purpose is to replace a damaged hip joint articulation, not to diagnose a condition.
No
The device description clearly states that the device is a physical component (liner) made of ultra high molecular weight polyethylene (UHMWPE) and is part of a modular system for total hip replacement. 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 clearly states that the Pinnacle AltrX Acetabular Cup Liners are for use in total hip replacement procedures. This is a surgical procedure performed on a patient's body.
- Device Description: The device is described as a physical component (liner) made of UHMWPE that is implanted into the hip joint to replace the natural articular surface.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
The device is a surgical implant used directly in a patient's body during a medical procedure, not a diagnostic tool used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The 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, 4. 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.
The subject liner is 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 seat and support the components.
Product codes
87 LPH, LZO
Device Description
The DePuy Pinnacle AltrX Acetabular Liner is 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-6A1-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter.
The subject Pinnacle AltrX liners are cross-linked UHMWPE acetabular cup liners that are available in a neutral, lateralized neutral, lipped or lateralized face-changing orientation.
subject liners are intended for use with modular, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range.
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
An in-vitro hip simulator wear study was conducted to support these wear claims. The study was conducted using test devices identified as AltrX Polyethylene Liners and control devices identified as AltrX or Enduron™ Polyethylene Acetabular Cup Liners (inner diameter of 28 mm or 36 mm) used with DePuy cobalt chromium or Delta Ceramic Femoral Heads. The control devices are manufactured by DePuy Orthopaedics, Inc. of ram-extruded bars and machined into Pinnacle liners. The test devices are manufactured by DePuy Orthopaedics, Inc. of ram-extruded bars, irradiated to 7.5 Mrad in vacuum, remelted and machined into Pinnacle liners. The subject liners were not terminally sterilized prior to testing.
Test and control liners were tested for 5 million cycles using a 12-station orbital bearing hip simulator manufactured by Shore Western Manufacturing Inc. The thickness of the test liner was 5.53 mm. The heads were roughened after 5 million cycles by tumbling for 30 minutes with a bauxite/alumina abrasive media in a tabletop tumbler made by A.E. Aubin Co. and tested for an additional 2 million cycles against the liners. The articulating components for the test and control liners include 28 mm and 36 mm CoCrMo femoral heads, and 36 mm ceramic femoral heads. The lubricant used in the study was 90% bovine serum with 0.2% NaN3 and 20mM EDTA.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: In-vitro hip simulator wear study.
Sample Size: Not explicitly stated as a number of samples, but refers to "test devices" and "control devices" with different types of liners and femoral heads.
Key Results: The wear rates determined at the conclusion of the study were 34.3 ± .51 mg/million cycles (mg/MC) for the 28 mm CoCrMo femoral head/Enduron group (control), 31.54 ± 0.8 mg/MC for the 36 mm CoCrMo femoral head/Enduron group (control), 4.99 ± 0.66 mg/MC for the 36 mm CoCrMo femoral head/AltrX (control), and 3.32 ± 0.38 mg/MC for the 36 mm ceramic femoral head/AltrX test group.
The following marketing claim will be made for the Pinnacle Altrx liner:
Pinnacle AltrX UHMWPE liners (articulated against ceramic heads) reduce wear by 33% compared to articulation against cobalt-chromium heads.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Wear rates (mg/million cycles)
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
K072963 # 1/3
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93) virus
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Rhonda Myer
Regulatory Affairs Associate
Telephone: (574) 371-4927
Facsimile: (574) 371-4987
Electronic Mail: Rmyer7@dpyus.jnj.com |
| DATE PREPARED: | October 9, 2007 |
| PROPRIETARY NAME: | DePuy Pinnacle® AltrX™ Acetabular Liners |
| COMMON NAME: | Polyethylene Acetabular Cup Liner |
| CLASSIFICATION: | Class II per 21 CFR 888.3358, Hip joint
metal/polymer/metal, semi-constrained, porous
coated, uncemented prosthesis
Class II per 21 CFR 888.3353, Hip joint
metal/ceramic/polymer semi-constrained
cemented or non-porous uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH, LZO |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Pinnacle® AltrX™ Acetabular Liners,
K062148, October 24, 2006 |
DEVICE DESCRIPTION:
The DePuy Pinnacle AltrX Acetabular Liner is 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-6A1-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter.
The subject Pinnacle AltrX liners are cross-linked UHMWPE acetabular cup liners that are available in a neutral, lateralized neutral, lipped or lateralized face-changing orientation. The
1
K072913 * 2/3
subject liners are intended for use with modular, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range.
The following marketing claim will be made for the Pinnacle Altrx liner:
Pinnacle AltrX UHMWPE liners (articulated against ceramic heads) reduce wear by 33% compared to articulation against cobalt-chromium heads.
An in-vitro hip simulator wear study was conducted to support these wear claims. The study was conducted using test devices identified as AltrX Polyethylene Liners and control devices identified as AltrX or Enduron™ Polyethylene Acetabular Cup Liners (inner diameter of 28 mm or 36 mm) used with DePuy cobalt chromium or Delta Ceramic Femoral Heads. The control devices are manufactured by DePuy Orthopaedics, Inc. of ram-extruded bars and machined into Pinnacle liners. The test devices are manufactured by DePuy Orthopaedics, Inc. of ram-extruded bars, irradiated to 7.5 Mrad in vacuum, remelted and machined into Pinnacle liners. The subject liners were not terminally sterilized prior to testing.
Test and control liners were tested for 5 million cycles using a 12-station orbital bearing hip simulator manufactured by Shore Western Manufacturing Inc. The thickness of the test liner was 5.53 mm. The heads were roughened after 5 million cycles by tumbling for 30 minutes with a bauxite/alumina abrasive media in a tabletop tumbler made by A.E. Aubin Co. and tested for an additional 2 million cycles against the liners. The articulating components for the test and control liners include 28 mm and 36 mm CoCrMo femoral heads, and 36 mm ceramic femoral heads. The lubricant used in the study was 90% bovine serum with 0.2% NaN3 and 20mM EDTA. The wear rates determined at the conclusion of the study were 34.3 ± .51 mg/million cycles (mg/MC) for the 28 mm CoCrMo femoral head/Enduron group (control), 31.54 ± 0.8 mg/MC for the 36 mm CoCrMo femoral head/Enduron group (control), 4.99 ± 0.66 mg/MC for the 36 mm CoCrMo femoral head/AltrX (control), and 3.32 ± 0.38 mg/MC for the 36 mm ceramic femoral head/AltrX test group.
Note: Reduced Wear Claims are based on the results of in-vitro hip wear simulator tests which have not been shown to quantitatively predict clinical wear performance
INDICATIONS AND INTENDED USE:
Indications:
The 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.
2
-
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery, including joint reconstruction, internal fixation, 4. 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 liner is 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 seat and support the components.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Pinnacle AltrX Acetabular Liner described in this submission is identical to the DePuy Pinnacle AltrX Acetabular Liner previously cleared in K062148 on October 24, 2006. The subject liners have not been modified from the previously cleared Pinnacle AltrX liners, and based upon the referenced testing, DePuy wishes to make a claim of reduced wear when the subject liners are used with ceramic femoral heads.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is made up of several curved lines, and the text is in a simple sans-serif font. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.
JAN - 9 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Depuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, IN 46582
Re: K072963 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 Dated: January 2, 2008 Received: January 3, 2008
Dear Ms. Myer:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 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 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); 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
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510 (k) Number (if known): | K072963 |
|---|---|
| ---------------------------- | --------- |
DePuy Pinnacle® AltrX™ Acetabular Cup Liner Device Name:
Indications for Use:
The 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 1. arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery, including joint reconstruction, internal fixation, 4. arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- న్. Certain cases of ankylosis
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.
| Prescription Use X
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
| ---------------------------------------------------------- | -------- | ------------------------------------------------ |
|---|
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Sorbaue Bnem Rfm Page 1 of 1
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K072963