(65 days)
Not Found
No
The summary describes a mechanical implant (acetabular cup) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes.
The device is indicated for use in conditions that cause severe pain and/or disability, with the intent to increase patient mobility and reduce pain, which aligns with the definition of a therapeutic device.
No
The provided text describes the Pinnacle 100 with Gription Acetabular Cup as an implant used in total hip replacement, intended to replace a damaged hip joint and provide increased mobility and pain reduction. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states the device is a physical implantable component (acetabular cup) made of titanium alloy and UHMWPE or CrCoMo, 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 device is for use as part of a total hip replacement to treat various conditions affecting the hip joint. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details a physical implantable device made of titanium alloy and polyethylene or cobalt chrome, designed to replace a damaged hip joint. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Pinnacle 100 with Gription Acetabular Cup is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.
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.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWA, JDI, LZO and 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 polyetheylene (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. The subject acetabular cup is 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
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
DePuy Orthopaedics, Inc.
JUN 1 2 2009
NAME OF SPONSOR:
510(K) CONTACT:
DATE PREPARED:
COMMON NAME:
CLASSIFICATION:
PROPRIETARY NAME:
700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910
Rhonda Myer Senior Regulatory Affairs Associate Telephone: (574) 371-4927 Facsimile: (574) 371-4987 Electronic Mail: Rmyer7@its.jnj.com
May 13, 2009
DePuy Pinnacle® 100 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
Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis
Class II per 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis
DEVICE PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICES:
Pinnacle with Gription Acetabular Cups, K071784 (July 25, 2007) Pinnacle Acetabular System (Porocoat), K001534 (June 12, 2000)
KWA, JDI, LZO and LPH
DePuy Orthopaedics, Inc.
K090998: Additional Information Pinnacle 100 with Gription
1
K०५०५५४
p.2/2
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 polyetheylene (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. The subject acetabular cup is coated with a proprietary titanium porous coating, Gription.
INDICATIONS AND INTENDED USE:
Indications:
The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.
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.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications.
- Certain cases of ankylosis.
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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Pinnacle 100 with Gription Acetabular Cup is substantially equivalent in geometry to the Pinnacle 100 Acetabular Cups (with Porocoat) cleared in K001534, and substantially equivalent in porous coating to the Pinnacle Cups with Gription cleared in K071784 based on similarities in intended use, indications for use, material, design, sterilization, packaging and method of manufacturing.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the first line and "Service" on the second line. The text is centered and appears to be extracted from a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2009
DePuy Orthopaedics, Incorporated c/o Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582 ·
Re: K090998
Trade/Device Name: DePuy Pinnacle 100 with Gription Acetabular Cups Regulation Number: 21 CFR 888.3330
Regulation Name: Hip Joint Metal/Metal Semi-Constrained, With an Uncemented Acetabular Component, Prosthesis
Regulatory Class: Class iII Product Code: KWA, JDI, LZO, LPH Dated: May 14, 2009 Received: May 15, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting
3
Page 2-Ms. Rhonda Myer
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Вавене Внелит
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1090998
Indications for Use Statement
510 (k) Number (if known): K090998
DePuy Pinnacle® 100 with Gription™ Acetabular Cup Device Name:
Indications for Use:
The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.
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.
Porous-coated Pinnacle Acetabular Cups are indicated for 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)
Jauta
(Division Sign-Off)
for
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090998