(87 days)
Not Found
No
The 510(k) summary explicitly states that the changes are limited to modifications of the Instructions for Use (IFU) and that there are no changes to the device design. There is no mention of AI, ML, image processing, or any related concepts.
Yes
The device is an acetabular cup liner used in total hip replacement procedures, which is a therapeutic intervention for patients with severe hip joint pain and disability.
No
This device is a prosthetic implant (acetabular cup liners) used in hip replacement surgery, not a diagnostic tool. Its purpose is to replace damaged hip joint components, not to diagnose a condition.
No
The device is a physical implant (acetabular cup liners) and the 510(k) is for modifications to its Instructions for Use, not for a software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for total hip replacement surgery. IVDs are used in vitro (outside the body) to examine specimens from the human body.
- Device Description: The description refers to "Acetabular Cup Liners," which are components of a hip implant, not a diagnostic test.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
The device is a surgical implant used for treatment, not for diagnosis.
N/A
Intended Use / Indications for Use
The Pinnacle Metal-on-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.
Product codes (comma separated list FDA assigned to the subject device)
KWA
Device Description
The subject of this 510(k) consists of modifications to the Instructions for Use (IFU). The following two contraindications and potential adverse effect have been added to the IFU. DePuy Orthopaedics is making these IFU revisions to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice. These are the only changes to the labeling and IFU; there are no changes to the device design.
Contraindications:
- Use is contraindicated in cases with chronic renal failure.
- Females of childbearing age are contraindicated due to the unknown effects of elevated levels of metal ions on the fetus.
Potential adverse effect:
- The potential long-term biological effects of metal wear debris and metal ion production are not known.
No changes have been made to the Indications for Use or the Intended Use of this device.
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)
Not Found
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.
K062426, K023786, K003523, K002883, K082446
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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K083642 (pg 1/2)
MAR 6 2009
510 (k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)
NAME OF SPONSOR:
510(K) CONTACT:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910
Dawn Sinclair Regulatory Affairs Associate Telephone: (574) 372-5023 Facsimile: (574) 371-4987 Electronic Mail: Dsincla3@its.jnj.com
DATE PREPARED:
PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION:
December 5, 2008
87 KWA
DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners
Acetabular Cup Prosthesis
Class III per 21 CFR 888.3330, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
DEVICE PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICE(S):
DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K062426 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K023786 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K003523 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K002883 Biomet® Metal-on-Metal Hip Systems, K082446
1
K083642.(pg 2/2)
DESCRIPTION:
The subject of this 510(k) consists of modifications to the Instructions for Use (IFU). The following two contraindications and potential adverse effect have been added to the IFU. DePuy Orthopaedics is making these IFU revisions to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice. These are the only changes to the labeling and IFU; there are no changes to the device design.
Contraindications:
- Use is contraindicated in cases with chronic renal failure. .
- Females of childbearing age are contraindicated due to the unknown effects of . elevated levels of metal ions on the fetus.
Potential adverse effect:
- The potential long-term biological effects of metal wear debris and metal ion . production are not known.
No changes have been made to the Indications for Use or the Intended Use of this device.
INDICATIONS AND INTENDED USE:
Indications:
The Pinnacle Metal-on-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Intended Use:
The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Associate, Regulatory Affairs 700 Orthopaedic Dr. Warsaw, Indiana 46581
MAR 6 2009
Re: K083642
Trade/Device Name: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint, metal/metal semi-constrained, with an uncemented acctabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: December 8, 2008
Dear Ms. Sinclair:
Received: December 9, 2008
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
3
Page 2 - Ms. Dawn Sinclair
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.
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 the reporting 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. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510 (k) Number (if known): 16083642 (po 1/1)
Device Name: DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners
Indications for Use:
The Pinnacle Metal-on-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, silipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
() x Sh Yo
(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)
CDRH, Office of Device Evaluation (ODE)
Mark H. Milliken
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
0000
510(k) Number