(80 days)
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.
The subject Pinnacle" Constrained Acetabular Liner is intended to be used with the DePuy Pinnacle" metal acetabular shells and Self-centering™ (bipolar) heads to resurface the acctabular socket in cementless total hip arthroplasty.
The 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-6Al-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 Pinnacle" Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with Self-Centering (bipolar) femoral heads within the 40mm-44mm size range. The 62mm-76mm outer diameters (ODs) are geometrically the same as other smaller OD Pinnacle Acetabular Liners cleared in K043058.
I am sorry, but the provided text from K052079 does not contain information about acceptance criteria, device performance metrics, or details of any studies (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information) that would be used to prove the device meets acceptance criteria.
The document is a 510(k) summary for a medical device (DePuy Pinnacle Constrained Acetabular Liners), which primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, materials, and manufacturing methods. It states that the "design is identical to the DePuy predicate and does not raise any new issues of safety or effectiveness," which suggests equivalence was established through comparison rather than a detailed performance study with specified acceptance criteria for the new device.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about a study based on the input provided.
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Image /page/0/Picture/1 description: The image contains a handwritten text that appears to be the characters "L" and "f" followed by the number "2". The characters are written in a simple, slightly cursive style, with the "f" having a loop extending below the baseline. The number "2" is connected to the "f" and has a horizontal line extending to the right.
OCT 2 1 2005
510(k) SUMMARY
Submitted July 28, 2005
Image /page/0/Picture/5 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a solid black circle followed by the name "DePuy" in a bold, sans-serif font. A horizontal line underlines the name, and below the line is the text "a Johnson & Johnson company" in a smaller, more stylized font.
DePuy Orthopaedics, Inc.
P0 Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
USA Tel: +1 (574) 267 8143
| NAME OF FIRM: | DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46580 |
|---|---|
| 510(K) CONTACT: | Keli K. HankeeClinical Research AssociateDePuy Orthopaedics, Inc.PO Box 988700 Orthopaedic DriveWarsaw, IN 46580 |
| TRADE NAME: | DePuy Pinnacle * Constrained Acetabular Liners |
| COMMON NAME: | Acetabular Cup Liner |
| CLASSIFICATION: | Class II, per 21 CFR, 888.3310Hip joint metal/polymer/ metal, constrained, cemented oruncemented prosthesis |
| DEVICE PRODUCT CODE: | 87 KWZ |
| SUBSTANTIALLYEQUIVALENT DEVICES: | Osteonics Constrained Acetabular InsertsDePuy Pinnacle ® Constrained Acetabular Liners |
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Image /page/1/Figure/0 description: The image contains handwritten text. The text appears to be a combination of letters and numbers, specifically "K652079" and "2013". The handwriting style is casual and slightly slanted. The text is written in black ink on a white background.
DEVICE DESCRIPTION:
The 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-6Al-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 Pinnacle" Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with Self-Centering (bipolar) femoral heads within the 40mm-44mm size range. The 62mm-76mm outer diameters (ODs) are geometrically the same as other smaller OD Pinnacle Acetabular Liners cleared in K043058.
INDICATIONS AND INTENDED USE:
Indications:
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.
Intended Use:
The subject Pinnacle" Constrained Acetabular Liner is intended to be used with the DePuy Pinnacle" metal acetabular shells and Self-centering™ (bipolar) heads to resurface the acctabular socket in cementless total hip arthroplasty.
Basis of Substantial Equivalence:
The DePuy Pinnacle" Constrained Acetabular Liner (lateralized neutral and lateralized facechanging), described in this submission is substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. The design is identical to the DePuy predicate and does not raise any new issues of safety or effectiveness.
DePuy believes that the DePuy Pinnacle" Constrained Acetabular Liner is substantially equivalent to the previously cleared and approved devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design resembling an eagle or a stylized human figure with three heads or faces in profile. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the design in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2005
Keli K. Hankee Clinical Research Associate DePuy Orthopaedics, Inc PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581
Re: K052079
R032079
Trade/Device Name: Pinnacle® Constrained Acetabular Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis Regulatory Class: II Product Code: KWZ Dated: July 29, 2005 Received: August 02, 2005
Dear Ms. Hankee:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreative to togens and the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de necs that have been resuire approval of a premarket approval application (PMA). and Costine Tree (11ct) that to hovice, subject to the general controls provisions of the Act. The r ou may, dicrerere, mainer of the Act include requirements for annual registration, listing of general controls proving 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 If your device is exablical controls. Existing major regulations affecting your device can may or subject to back as a substions, 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 that I DA has Intact and regulations administered by other Federal agencies. You must or any I Gaetar Buttated and states and the mot 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 forth in and quand of of of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Keli K. Hankee
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you've ought finding of substantial equivalence of your device to a legally prematication: "The PDF Intelling of easification 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 If you desire specific advice ion your as (240) 276-0210. 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 other general information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
summitry,
for Mark N. Mollen
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _ Pinnacle" Constrained Acetabular Liner
Indications for Use:
The Pinnacle" Constrained Acetabular Liner is indicated for use as a component of a total hip The I milace - Constramed Hocatients at high risk of hip dislocation due to a history of prior prosulesis in primary of for 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.
Over-The-Counter Use Prescription Use _ 人 AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052079
§ 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.”