(28 days)
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 non-union 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 28mm diameter Co-Cr-Mo femoral heads only.
The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner has a 28mm inner diameter and is offered in a neutral style only. The Pinnacle MOM liner is mechanically locked with the shell via a taper junction, and articulates with commercially available prosthetic femoral heads.
This document is a 510(k) summary for the DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, it does not contain a study proving the device meets acceptance criteria.
The document states: "The Pinnacle Metal-On-Metal Acetabular Cup Liners are nearly identical to the Ultima Metal-On-Metal Acetabular Cup Liners that were cleared previously. The intended use, articular surface, material and locking mechanism with the outer shell are the same. The only changes are minor design changes that allow the liners to be used with the Pinnacle Acetabular Shells that have been cleared previously."
This statement indicates that the device's acceptance is based on its substantial equivalence to an already approved device (DePuy Ultima Metal-On-Metal Acetabular Cup Liners), rather than a new study with specific acceptance criteria and performance metrics detailed here.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this document is not a study report.
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988 |
|---|---|
| 510(k) CONTACT: | Cheryl HastingsDirector, Regulatory Affairs |
| TRADE NAME: | DePuy Pinnacle Metal-On-Metal Acetabular CupLiners |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | 888.3330 Hip joint metal/metal semi-constrained, withan uncemented acetabular component, prosthesis |
| DEVICE PRODUCT CODE: | 87 JDM |
| SUBSTANTIALLY EQUIVALENT DEVICES: | DePuy Ultima Metal-On-Metal Acetabular Cup |
DEVICE DESCRIPTION AND INTENDED USE:
The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner has a 28mm inner diameter and is offered in a neutral style only. The Pinnacle MOM liner is mechanically locked with the shell via a taper junction, and articulates with commercially available prosthetic femoral heads.
It is 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 non-union 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 Limers are intended for use with DePuy Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Pinnacle Metal-On-Metal Acetabular Cup Liners are nearly identical to the Ultima Metal-On-Metal Acetabular Cup Liners that were cleared previously. The intended use, articular surface, material and locking mechanism with the outer shell are the same. The only changes are minor design changes that allow the liners to be used with the Pinnacle Acetabular Shells that have been cleared previously.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.
Public Health Service
OCT 1 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K002883
Trade Name: Pinnacle Metal-On-Metal Acetabular Cup Liners Regulatory Class: III Product Codes: JDM and KWA Dated: September 13, 2000 Received: September 15, 2000
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have hove have determined the device is substantially equivalent (for the indications for use above and 10 and 10 and 11 interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Cheryl K. Hastings
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and II you desire specific actice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for mi This anaguestions on the promotion and advertising of your device, (201) 594-4639. Tructionally, for quest at (301) 594-4639. Also, please note the factory of prease contact the Office or Compilance an (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsibilities and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neik.P.D. for
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) KU02883
Device Name DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners
Indications for Use:
Indications for Use:
The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acti The Pinnacle Metal-On-Metal Acclaidian Cap Patients suffering severe pain and component in total lilip replacement procession the mossio, and non union of femora disability due to structural damage in the ling Jour non non-union of femoral
post-traumatic arthritis, collagen disorders, avascular necrosis, and non-unital hindysplasja, post-fraumatic artimus, collaged undicated for patents with congenital hip dysplasia,
fractures. Use of the prosthesis is also indicated for parents his are to previous fivio fractures. Use of the prosulesis is also marcal epiphysis and disability due to previous fusion, prom asto acentibut, shpped capital read.
where bone stock is inadequate for other reconstruction techniques.
The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy I he Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.
Nilo Aricma
(Division Sign-Off) Division of General Restorative Devices 1002883 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The Counter Use
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§ 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.