(22 days)
Not Found
No
The description focuses on the materials and mechanical design of a hip replacement system, with no mention of AI/ML or related concepts like image processing, data sets, or performance metrics associated with algorithmic analysis.
Yes.
The device is indicated for specific medical conditions such as osteoarthritis, traumatic arthritis, and avascular necrosis of the femoral head, and is used in total hip replacement to alleviate pain and restore joint function.
No
The device is an acetabular cup designed for total hip replacement, which is a therapeutic intervention, not a diagnostic tool.
No
The device description clearly states that the device is a physical implantable component (acetabular cup) made of titanium alloy and polyethylene or cobalt chrome, which are hardware materials.
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 total hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The device is described as a modular system for total hip replacement, consisting of physical components (outer shell and liner) designed to be implanted into the body. This is characteristic of a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Indications:
The Pinnacle Acetabular Cups are indicated for total hip replacement in the following conditions:
-
- A severely painful and/or a severely disabled joint resulting 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 arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless application.
Intended Use:
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.
Pinnacle porous-coated Acetabular Cup total hip components are indicated for cementless use with fixation provided by biological tissue ingrowth into the porous coating.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDI, LZO, LPH
Device Description
The Pinnacle Acetabular System is part of a modular system for use 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 ultra high molecular weight polyethylene (UHMWPE) or high-carbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. which mates with a compatible DePuy femoral stem. The subject acetabular cups are coated with a proprietary titanium porous coating, Gription™.
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.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K09364/6
DEC 1 7 2009
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
NAME OF SPONSOR:
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910
510(K) CONTACT:
DATE PREPARED: PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION:
Rhonda Myer Senior Regulatory Affairs Associate
Telephone: (574) 371-4927 Facsimile: (574) 371-4987 Electronic Mail: rmyer7(@its.jnj.com
December 15, 2009
DePuy Pinnacle® with Gription™ Acetabular Cups
Acetabular Cup with Porous Coating
Class III per 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (KWA)
Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis (JDI)
Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (LZO)
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis (LPH)
DEVICE PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICE:
KWA, JDI, LZO, LPH
Pinnacle 100 with Gription Acetabular Cups, K090998, cleared on June 12, 2009 Pinnacle with Gription Acetabular Cups, K071784, cleared on July 25, 2007
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DEVICE DESCRIPTION:
The Pinnacle Acetabular System is part of a modular system for use 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 ultra high molecular weight polyethylene (UHMWPE) or high-carbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. which mates with a compatible DePuy femoral stem. The subject acetabular cups are coated with a proprietary titanium porous coating, Gription™.
INDICATIONS AND INTENDED USE:
Indications:
The Pinnacle Acetabular Cups are indicated for total hip replacement in the following conditions:
-
- A severely painful and/or a severely disabled joint resulting 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 arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless application.
Intended Use:
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.
Pinnacle porous-coated Acetabular Cup total hip components are indicated for cementless use with fixation provided by biological tissue ingrowth into the porous coating.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject Pinnacle with Gription Acetabular Cups are identical to those cleared in K071784. The only change proposed is to add three FDA classifications to the classification cleared in K071784 (LPH) so that the classifications for all Pinnacle with Gription Cups are the same as those cleared for the Pinnacle 100 with Gription Cups in K090998 (LPH, KWA, JDI, LZO). Based on the similarities in intended use, indications for use, materials, method of manufacturing, design, sterilization and
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2
packaging method, the subject cups are substantially equivalent to the Pinnacle 100 with Gription Acetabular Cups cleared in K090998.
.
p. 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Senior Regulatory Affairs Associate PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46582-0988
DEC 1 7 2009
Re: K093646
Trade/Device Name: DePuy Pinnacle with Gription Acetabular Cups Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular, prosthesis
Regulatory Class: Class III Product Code: KWA, JDI, LZO, LPH Dated: November 23, 2009 Received: November 25, 2009
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 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
4
Page 2 - Ms. Rhonda Myer
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510 (k) Number (if known): K093646
Device Name: DePuy Pinnacle with Gription Acetabular Cups
Indications for Use:
DePuy Pinnacle with Gription Acetabular Cups are indicated for total hip replacement in the following conditions:
-
- A severely painful and/or a severely disabled joint resulting 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;
-
- Freated previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless application.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/CIR
(21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Smita for nxm
(Division Sign-Off) D. media
(Division Sign of Surgical, Orthopedic, Divisionative Devices
510(k) Number K093646
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DePuy Orthopedics, Inc.
Pinnacle with Gription: Special 510(k)