(28 days)
No
The device description focuses on the mechanical components and materials of a hip implant liner, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a component of a total hip prosthesis intended to replace the natural articular surface of the hip joint in total hip replacement, which is a therapeutic intervention. It is indicated for use in patients at high risk of hip dislocation to treat or mitigate this condition.
No
The device is a component of a total hip prosthesis, designed to replace the natural articular surface of the hip joint, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states the device is a physical component (liner) made of UHMWPE and titanium, designed to be implanted in the hip joint. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "resurface the acetabular socket in cementless total hip arthroplasty" and is indicated for use as a "component of a total hip prosthesis." This describes a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant made of UHMWPE and titanium, designed to replace a part of the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly an in vivo surgical implant.
N/A
Intended Use / Indications for Use
Intended Use: The subject Constrained Liner is intended to be used with the DePuy Pinnacle® metal acetabular shells, DePuy Modular M femoral heads and Self-centering™ (bipolar) femoral heads to resurface the acetabular socket in cementless total hip arthroplasty.
Indications for Use: The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.
Product codes (comma separated list FDA assigned to the subject device)
87 KWZ
Device Description
The DePuy Pinnacle® Constrained 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 femoral head of an appropriate diameter.
The Pinnacle® Constrained Acetabular Liner mechanically constrains the femoral head within the ID of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The subject DePuy Pinnacle® Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized facechanging orientation and have inner diameters (ID) compatible with Self-Centering™ (bipolar) femoral heads within the 40mm - 44mm size range. The liners are identical in design to those cleared in K052079 on October 21, 2005. The compatible components are being extended in this submission to include DePuy Modular M femoral heads (cleared in K060031 on January 31, 2006) within the 40mm - 44mm 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
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
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”
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K071117 pg.123
Section 5–510 (k) Summary
MAY 1 8 2007
(As required by 21 CFR 807.92(c) and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Natalie Heck
Manager, Regulatory Affairs
Telephone: (574) 372-7469
Facsimile: (574) 371-4987
Electronic Mail: NHeck@dpyus.jnj.com |
| 510(K) PREPARER: | Rebecca Lennard
Independent Contractor
Electronic Mail: RLennard@dpyus.jnj.com |
| DATE PREPARED: | October 16, 2006 |
| PROPRIETARY NAME: | DePuy Pinnacle® Constrained Acetabular Liner |
| COMMON NAME: | Acetabular Cup Liner |
| CLASSIFICATION: | Class II per 21 CFR 888.3310, Hip joint
metal/polymer/metal, constrained, cemented or
uncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 KWZ |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Pinnacle® Constrained Acetabular Liner
K052079
DePuy Pinnacle® Constrained Acetabular Liner
K043058
DePuy Modular M Femoral Head, K060031 |
1
DEVICE DESCRIPTION:
The DePuy Pinnacle® Constrained 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 femoral head of an appropriate diameter.
The Pinnacle® Constrained Acetabular Liner mechanically constrains the femoral head within the ID of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The subject DePuy Pinnacle® Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized facechanging orientation and have inner diameters (ID) compatible with Self-Centering™ (bipolar) femoral heads within the 40mm - 44mm size range. The liners are identical in design to those cleared in K052079 on October 21, 2005. The compatible components are being extended in this submission to include DePuy Modular M femoral heads (cleared in K060031 on January 31, 2006) within the 40mm - 44mm size range.
INTENDED USE AND INDICATIONS:
Intended Use:
The subject Constrained Liner is intended to be used with the DePuy Pinnacle® metal acetabular shells, DePuy Modular M femoral heads and Self-centering™ (bipolar) femoral heads to resurface the acetabular socket in cementless total hip arthroplasty.
Indications for Use:
The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.
BASIS OF SUBSTANTIAL EQUIVALENCE:
2
The DePuy Pinnacle® Constrained Acetabular Liner described in this submission is identical to the DePuy Pinnacle® Constrained Acetabular Liner previously cleared in K052079 on October 21, 2005. There have been no design modifications to the Pinnacle Constrained Acetabular Liner. The DePuy Modular M femoral head compatible component described in this submission is identical to the DePuy Modular M femoral head previously cleared in K060031 on January 31, 2006. There have been no design modifications to the DePuy Modular M femoral heads.
The articulation of the DePuy Pinnacle Constrained Acetabular Liner with the DePuy Modular M femoral heads is substantially equivalent to the predicate device (K043058 cleared on March 14, 2005) based on similarities in design, intended use, material and manufacturing methods. The DePuy Modular M femoral head mating components, while not identical in size to the predicate, do not raise any new issues of safety or effectiveness.
DePuy believes that the articulation of the DePuy Pinnacle® Constrained Acetabular Liner and the DePuy Modular M femoral head is substantially equivalent to the previously cleared devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol that resembles a human figure in profile, with three overlapping shapes representing different aspects of health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2007
DePuy Orthopaedics, Inc. % Ms. Natalie Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K071117
Trade/Device Name: DePuy Pinnacle® Constrained Acetabular Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWZ Dated: April 19, 2007 Received: April 20, 2007
Dear Ms. Heck:
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
Page 2 - Ms. Natalie S. Heck
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" (21CFR 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,
Buch
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 3 – Ms. Natalie S. Heck
cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- 410 DGRND D.O. f/t:ELF:afb:5/16/07
:
OC Numbers:
| Division of Enforcement A | 240-276-
0115 |
|------------------------------------------------------------------------------------|------------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-
0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-
0115 |
| General Hospital Devices Branch | 240-276-
0115 |
| General Surgery Devices Branch | 240-276-
0115 |
| Division of Enforcement B | 240-276-
0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-
0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices and
Radiological Devices | 240-276-
0120 |
6
Section 4 - Indications for Use Statement
Ko 71117 ---------------------------------------------------------------------------------------------------------------510 (k) Number (if known): __
DePuy Pinnacle® Constrained Acetabular Liner Device Name:
Indications for Use:
The Pinnacle® Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.
The Pinnacle® Constrained Acetabular Liner is indicated for use with the Pinnacle® Acetabular Cup in cementless application.
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________
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) Barbara Buehl
Page 1 of 1
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K071117
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