(119 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 M-Spec 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 Pinnacle Acetabular Shells that have been cleared previously. The liners currently are offered with inner diameters (ID) of 28-36mm, this modification is to add 40 and 44mm Ids and to add a 36mm liner with a outer diameter (OD) of 50mm. The liners are offered in a neutral style only. The subject Pinnacle MOM liner is mechanically locked with the shell via a taper junction which is identical to the taper junction used for the cleared 28 and 36mm liners and articulates with previously cleared M-Spec metal prosthetic femoral heads.
The provided text is a 510(k) summary for the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance data for a device.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets those criteria, as this information is not contained within the provided text. The document is for a medical device that has been cleared through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance criteria through a new study.
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DEC 1 5 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988 |
|---|---|
| 510(k) CONTACT: | Anne M. SchulerSr. Regulatory Affairs Associate |
| DATE PREPARED: | August 17, 2006 |
| TRADE NAME: | DePuy Pinnacle Metal-on-Metal Acetabular CupLiners |
| COMMON NAME: | Acetabular Cup Liner |
| CLASSIFICATION: | Hip joint metal/metal semi-constrained with anuncemented acetabular component prosthesis (per 21CFR 888.3330), Class III Device |
| DEVICE PRODUCT CODE: | 87 KWA |
| SUBSTANTIALLY EQUIVALENTDEVICE(S): | DePuy Pinnacle 36mm Metal-On-Metal AcetabularCup Liners (K003523, cleared December 13, 2000)DePuy Pinnacle Metal-On-Metal Acetabular CupLiners (K002883, cleared Ocotober 13, 2000)DePuy ASR Modular Acetabular Cup System(K040627, cleared August 5, 2005) |
DEVICE INFORMATION:
A. DEVICE DESCRIPTION
The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with Pinnacle Acetabular Shells that have been cleared previously. The liners currently are offered with inner diameters (ID) of 28-36mm, this modification is to add 40 and 44mm Ids and to add a 36mm liner with a outer diameter (OD) of 50mm. The liners are offered in a neutral style only. The subject Pinnacle MOM liner is mechanically locked with the shell via a taper junction which is identical to the taper junction used for the cleared 28 and 36mm liners and articulates. with previously cleared M-Spec metal prosthetic femoral heads.
B. INTENDED USE AND INDICATIONS
Intended Use
The subject Pinnacle Metal-On-Metal Liners are intended to be used with the DePuy Pinnacle metal acetabular shells to resurface the acetabular socket in cementless total hip arthroplasty.
- 30 36 20 3 8 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
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Indications
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 for to structural damage in the hip joint from rheumatoid arthritis, osteoathinis, post-traumatic athritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congental hip dysplasio acetabuli, slipped capitolicios al 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 DePuyPinnacie Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only
C. BASIS OF SUBSTANTIAL EQUIVALENCE:
The modified Pinnacle Metal Acetabular Cup Liners have the same intended use, indications, manufacturing method, sterilization and packaging as the Pinnacle 36mm and 28mm Acetabular Liners cleared in K003523 and K002883 and the same intended use and indications as the ASR Modular Cup System cleared in K040627. The designs of the modified Pinnacle Metal Acetabular Cup Liners is similar to the design of the previously cleared Pinnacle Metal-On-Metal liners. The modified liners are offered in ange of sizes (inner and outer diameters) that fall within the range of sizes previously clearn for the ASR Modular Acetabular Cup System. Based on similarities in design, intended usa, indications, manufacturing methods, sterilization and packaging DePuy belineed that the Pinnacle Metal-On-Metal Acetabular Cup Liners are substantially equivalent to the previously cleared Pinnacle 36 and 28mm metal Acetabular Liners.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics Inc. % Ms. Kathy Harris Director of Regulatory Affairs 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
DEC 1 5 2006
Re: K062426
Trade/Device Name: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners 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 Dated: December 1, 2006 Received: December 4, 2006
Dear Ms. Harris:
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
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Page 2 - Ms. Kathy Harris
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 (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.
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 vours.
Sincerely yours,
Mark McMillan
Mark N. Melkerson 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): K062426 Device Name: _ DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners
Indications for Use:
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 pationts with congenital hip dysplasia, protrusio acelabuli, 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 DcPuv Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.
Prescription Use Over-The-Counter Use XX AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Miller
Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K062426
§ 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.