(89 days)
Not Found
No
The document describes a physical medical device (acetabular cup liners) and its material properties and wear performance. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on mechanical wear testing.
Yes
The device is specifically designed to alleviate pain and improve patient mobility by replacing a damaged hip joint, which falls under the definition of a therapeutic device.
No
Explanation: The device described is a hip implant component (acetabular cup liner) used in total hip replacement procedures. Its purpose is to replace damaged joint articulation, not to diagnose a condition or disease.
No
The device description clearly states it is a physical component (liner manufactured from cross-linked ultra high molecular weight polyethylene) that is part of a modular system designed to replace the natural articular surface of the hip joint. 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 is for total hip replacement procedures to replace a damaged hip joint articulation. This is a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a physical component (acetabular cup liner) designed to be implanted into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease or condition, or to analyze samples from the human body.
- Performance Studies: The performance studies focus on wear rates in a hip simulator, which is relevant to the mechanical function of an implant, not a diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The subject Pinnacle AltrX UHMWPE Liners are intended to be used with the DePuy Pinnacle metal acetabular shells, modular femoral heads, unipolar femoral heads, M-Spec heads, bi-polar self-centering heads and ceramic heads to resurface the acetabular socket in cementless total hip arthroplasty.
The Pinnacle AltrX™ Acetabular Cup Liners are indicated for use in total hip replacement procedures. 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. 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 is indicated for use with the Pinnacle Acetabular Cup in cementless application.
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with the Pinnacle Acetabular Cups in cementless applications.
Product codes (comma separated list FDA assigned to the subject device)
87 LPH, LZO
Device Description
The Pinnacle AltrX Acetabular Cup Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from cross-linked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a 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 liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size range offering.
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 two control devices identified as Marathon® Polyethylene liners and Enduron® Polyethylene liners. The test and control liners were manufactured by DePuv Orthopaedics by a ram extrusion process. The test and control liners had a thickness of 0.374 inches with a 28mm inner diameter and were gas plasma sterilized prior to the study.
Test and control liners were tested for 6 million cycles using an orbital bearing hip wear test machine manufactured by Shore Western Manufacturing Inc. The articulating component for both the test and control liners was a 28mm CoCr femoral head manufactured by DePuy Orthopaedics. 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
Key results: The wear rates determined at the conclusion of the study were 43.6 + 5.0 mg/million cycles (mg/MC) for the Enduron control, 7.3 ± 1.0 mg/MC for the Marathon control and 3.4 ± 0.2 mg/MC for the AltrX test material.
Marketing claim: AltrX™ UHMWPE liners reduce wear by 53% compared to previously cleared DePuy Marathon® UHMWPE liners while maintaining similar physical and mechanical properties as Marathon® UHMWPE. In addition. AltrX™ UHMWPE liners reduce wear by 92% compared to previously cleared conventional noncrosslinked UHMWPE liners.
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.
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
§ 888.3358 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
K06Z148
SUMMARY OF SAFETY AND EFFECTIVENESS
OCT 2 4 2006
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Anne M. Schuler
Sr Regulatory Affairs Associate |
| DATE PREPARED: | October 23, 2006 |
| TRADE NAME: | DePuy Pinnacle® AltrX™ Acetabular Cup Liner |
| COMMON NAME: | Acetabular Cup Liner |
| CLASSIFICATION: | CFR 888.3358 Hip joint metal/polymer/metal,
semi-constrained, porous-coated, uncemented
prosthesis, Class II device
CFR 888.3353 Hip joint metal/ceramic/polymer
semi-constrained cemented or non-porous
uncemented prosthesis, Class II device |
| DEVICE PRODUCT CODE: | 87 LPH, LZO |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Pinnacle® Acetabular Cup System ESL
Marathon™ Polyethylene liners (K033273,
cleared May 6, 2004)
DePuy Pinnacle® Acetabular System (K000306,
cleared March 23, 2000) |
Wright Medical LINEAGE® A-CLASS™ Poly Liner (K052026, cleared Dec 5, 2005)
DEVICE INFORMATION:
A. DEVICE DESCRIPTION
The Pinnacle AltrX Acetabular Cup Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner
1
manufactured from cross-linked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a 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 liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size range offering,
The following marketing claim will be made for the Pinnacle Altrx liner:
AltrX™ UHMWPE liners reduce wear by 53% compared to previously cleared DePuy Marathon® UHMWPE liners while maintaining similar physical and mechanical properties as Marathon® UHMWPE. In addition. AltrX™ UHMWPE liners reduce wear by 92% compared to previously cleared conventional noncrosslinked UHMWPE liners.
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 two control devices identified as Marathon® Polyethylene liners and Enduron® Polyethylene liners. The test and control liners were manufactured by DePuv Orthopaedics by a ram extrusion process. The test and control liners had a thickness of 0.374 inches with a 28mm inner diameter and were gas plasma sterilized prior to the study.
Test and control liners were tested for 6 million cycles using an orbital bearing hip wear test machine manufactured by Shore Western Manufacturing Inc. The articulating component for both the test and control liners was a 28mm CoCr femoral head manufactured by DePuy Orthopaedics. 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 43.6 + 5.0 mg/million cycles (mg/MC) for the Enduron control, 7.3 ± 1.0 mg/MC for the Marathon control and 3.4 ± 0.2 mg/MC for the AltrX test material.
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
2
B. INTENDED USE AND INDICATIONS
Intended Use
The subject Pinnacle AltrX UHMWPE Liners are intended to be used with the DePuy Pinnacle metal acetabular shells, modular femoral heads, unipolar femoral heads, M-Spec heads, bi-polar self-centering heads and ceramic heads to resurface the acetabular socket in cementless total hip arthroplasty.
Indications
The Pinnacle AltrX Acetabular Cup Liner is indicated for use in total hip replacement procedures. 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. 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 is indicated for use with the Pinnacle Acetabular Cup in cementless application.
C. BASIS OF SUBSTANTIAL EQUIVALENCE:
The Pinnacle AltrX Acetabular Cup Liners have the same design, intended use, manufacturing method, sterilization and packaging as the Pinancle Marathon Acetabular Liners cleared in K033273 and K000306. Mechanical testing shows that the AltrX liners perform similarly to the Marathon liners and exhibit less wear in hip simulator testing. Based on similarities in design, intended use, manufacturing method, sterilization and packaging DePuy believes that the Pinnacle® AltrX™ Acetabular Cup Liners are substantially equivalent to the previously cleared Pinnacle® Marathon™ Liners and to the previously cleared Wright Medical LINEAGE® A-CLASS™ Poly Liner which is similar in design, manufacturing method and intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Anne M. Schuler Sr. Regulatory Affairs Associate P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana
OCT 8 4 2006
Re: K062148 Trade/Device Name: DePuy Pinnacle Altrx™ Acetabular Cup 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: July 26, 2006 Received: July 27, 2006
Dear Ms. Schuler:
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. Insting 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
Page 2 -- Ms. Anne M. Schuler
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Ron Kirk
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
510(k) Number (if known): __ Ko 6 >14 8
Device Name: __ DePuv Pinnacle AltrXTMAce Device Name: DePuy Pinnacle AltrX™Acetabular Cup Liners
Indications for Use:
The Pinnacle AltrX™ Acetabular Cup Liners are indicated for use in total hip replacement procedures. 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. Total hip replacement is indicated in the following conditions:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid 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 the Pinnacle Acetabular Cups in cementless applications.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) | No |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | ---- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Division of Generen Restorative, Office of Device Evaluation (ODE)
and Neurological Devices
510 k02214/
0000003