(27 days)
Not Found
No
The device description and intended use are purely mechanical components for hip replacement, with no mention of software, algorithms, or data processing.
Yes
The device is indicated for use in surgical procedures to treat anatomical damage and conditions in the hip joint, which are therapeutic interventions.
No
The device is an acetabular cup liner used as a component in total hip replacement procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "metal liner" and describes its physical characteristics and how it mechanically locks with other hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip replacement. This is a medical device used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details a metal liner designed to be mechanically locked with an acetabular shell and articulate with a femoral head, all components of a hip prosthesis.
- 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 a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Pinnacle Metal-On-Metal Acetabular Cup Liner 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-traumaticarthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of this 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 28mm Metal-On-Metal Acetabular Cup Liners are intended for use with the DePuy Pinnacle Acetabular Shells and 28 mm diameter Co-Cr-Mo femoral heads.
Product codes (comma separated list FDA assigned to the subject device)
87 IDM KWA, KWA
Device Description
The Pinnacle Metal-On-Metal Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner is offered in both 28 mm and 36 mm inner diameter (ID) sizes with outer diameters (OD) ranging from 48mm through 66mm. The liner is offered in neutral style only. The metal-on-metal liner is mechanically locked with the acetabular shell via a taper junction, and articulates with commercially available prosthetic femoral heads.
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
§ 888.3330 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.
0
K023786 pg. 14
510(k) Summary
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 | DEC 1 0 2007 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) CONTACT: | Karla Ham
Sr. Regulatory Affairs Associate | |
| TRADE NAME: | DePuy Pinnacle Metal-on-Metal Acetabular Cup
Liner | |
| COMMON NAME: | Acetabular Cup Prosthesis | |
| CLASSIFICATION: | 888.3330: Hip joint metal/metal semi-constrained,
with uncemented acetabular component, prosthesis;
Class III | |
| DEVICE PRODUCT CODE: | 87 IDM KWA | |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy Pinnacle Metal-on-Metal Acetabular Cup
Liner. K002883 | |
DEVICE DESCRIPTION:
The Pinnacle Metal-On-Metal Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner is offered in both 28 mm and 36 mm inner diameter (ID) sizes with outer diameters (OD) ranging from 48mm through The liner is offered in neutral style only. The metal-on-metal liner is mechanically 66mm. locked with the acetabular shell via a taper junction, and articulates with commercially available prosthetic femoral heads.
INTENDED USE AND INDICATIONS:
The Pinnacle Metal-On-Metal Acetabular Cup Liner 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-traumaticarthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of this 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 28mm Metal-On-Metal Acetabular Cup Liners are intended for use with the DePuy Pinnacle Acetabular Shells and 28 mm diameter Co-Cr-Mo femoral heads.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Pinnacle Metal-On-Metal Acetabular Cup Liners in 44mm OD x 28mm ID and 46mm OD x 28mm ID sizes are identical to the previously cleared Pinnacle Metal-On-Metal Acetabular Cup Liners, K002883. The additional outer diameter sizes of 44mm are manufactured from the same material and have the same intended use as the previously cleared device.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.
Public Health Service
DEC 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karla A. Ham DePuy Orthopaedics, Inc. PO Box 988 700 Orthopedic Drive Warsaw, Indiana 46581
Re: K023786
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 Uncemented Acetabular Component, Prosthesis Regulatory Class: Class III Product Code: KWA Dated: November 8, 2002 Received: November 13, 2002
Dear Ms. Ham:
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
2
Page 2 - Ms. Karla Ham
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.
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Mah n Millhusan
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
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 hi 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 appremion ( femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protruction of slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inalequate for arth reconstruction procedures.
The Pinnacle 28mm Metal Acetabular Cup Liners are intended for use with the DePuy Pinnac Acetabular Shells and 28 mm diameter Co-Cr-Mo femoral heads.
Concurrence of CDRH, Office of Device Evaluation
y E Prescription Use (Per 21 CFR/801.109)
OR
Over-The-Counter Use
Mark A. Millman
ivision Sign-Off) (Division Sign Cral, Restorative Division of Sical Devices 023 78
510(k) Number --000003