(86 days)
Reference Device(s) K/DEN number: Not Found
No
The document describes a mechanical hip replacement system made of metal alloys, with no mention of software, data processing, or any AI/ML related terms.
Yes
The device is indicated for use in a total hip replacement, addressing conditions like severe pain, disability, avascular necrosis, and failed previous hip surgeries, all of which are medical conditions that benefit from treatment.
No
This device is a hip replacement system, indicated for surgical use in patients with painful and/or disabled hip joints. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components made of cobalt-chrome-molybdenum alloy, including acetabular cups and femoral heads, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the hip joint due to various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip replacement system (acetabular cup, femoral head, taper sleeve adapters) made of materials like cobalt-chrome-molybdenum. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the DePuy ASR™ XL Modular Acetabular Cup System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head and neck.
- Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
- Certain cases of ankylosis.
Porous-coated DePuy ASR™XL Modular Acetabular Cups are indicated for cementless application.
Intended Use:
The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component.
The DePuy ASR™ XL Modular Acetabular Cup System is compatible with DePuy ASR™ femoral components.
Product codes (comma separated list FDA assigned to the subject device)
87 KWA
Device Description
The subject DePuy ASR™ XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one-piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.
Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acctabular cups will be compatible with DePuy ASR™ femoral components.
The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The ASR Uni femoral heads (sizes 39mm through 55mm) were cleared in the DePuy ASR™ Modular Acetabular Cup System, K040627.
The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy.
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.
K040627, K073413, K021349, K965156, K070359, K042992, K073570
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
:
K080991 # '1/3
510(k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)
JUL - 2 *2008
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopacdic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER: | DePuy International Limited
St. Anthony Road
Leeds, United Kingdom LS11 8DT
Establishment Registration Number: 8010379 |
| 510(K) CONTACT: | Dawn Sinclair
Regulatory Affairs Associate
Telephone: (574) 372-5023
Facsimile: (574) 371-4987
Electronic Mail: Dsincla3@dpyus.jnj.com |
| DATE PREPARED: | February 25, 2008 |
| PROPRIETARY NAME: | DePuy ASR™ XL Modular Acetabular Cup
System |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | Class III per 21 CFR 888.3330, Hip joint
metal/metal semi-constrained, with an
uncemented acetabular component, prosthesis |
| DEVICE PRODUCT CODE(S): | 87 KWA |
| SUBSTANTIALLY EQUIVALENT
DEVICE(S): | DePuy ASR™ Modular Acetabular Cup System
(K040627)
DePuy ASR™ 300 Acetabular Cup System
(K073413)
Wright Medical Metal TRANSCEND®
Articulation System (Larger Sizes)
(K021349)
DePuy Ultima® Unipolar Head and Adapter
Sleeves (K965156)
DePuy ASR™ Taper Sleeve Adapter (K070359)
Corail AMT™ Hip Prosthesis (K042992)
DePuy Tri-Lock® Bone Preservation Stem
(K073570) |
:
・
.
1
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DEVICE DESCRIPTION:
The subject DePuy ASR™ XL Modular Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one-piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.
Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Modular Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acctabular cups will be compatible with DePuy ASR™ femoral components.
The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The ASR Uni femoral heads (sizes
39mm through 55mm) were cleared in the DePuy ASR™ Modular Acetabular Cup System, K040627.
The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy.
INDICATIONS AND INTENDED USE:
Indications for Use:
The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head and neck.
-
- Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
-
- Certain cases of ankylosis.
2
080991 # 3/3
Porous-coated DePuy ASR™XL Modular Acetabular Cups are indicated for cementless application.
Intended Use:
The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component.
The DePuy ASR™ XL Modular Acetabular Cup System is compatible with DePuy ASR™ femoral components.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy ASR" XL Modular Acetabular Cup components described in this submission are, in our opinion, substantially equivalent to those included in the previously cleared DePuy ASR" Modular Acetabular Cup System (K040627); the DePuy ASR" 300 Acetabular Cup System (K073413); the Wright Medical Metal TRANSCEND® Articulation System (K021349); the DePuy ASR™ Adapter Sleeve (K070359); the DePuy Ultima "Adapter Sleeves (K965156); the Corail AMT" Hip Prosthesis (K042992); and the DePuy Tri-Lock® Bone Preservation Stem (K073570), based upon the similarities in design, material composition and intended use/indications for use. A modification is simply being made to add additional cup sizes. In addition, minor revisions are being made to the Indications for Use and the Instructions for Use (IFU) to mininimize the necessity for multiple IFUs and to update the contents to reflect current practice unc subject device does not raise any new issues of safety or effectiventess.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2008
DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K080991
Trade/Device Name: DePuy ASRIM XL Modular Acetabular Cup System 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: March 17, 2008 Received: April 7, 2008
Dear Ms. Sinclair:
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
4
Page 2 - Ms. Dawn Sinclair
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Mark H. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
| 510 (k) Number (if known): | K080991 |
|---|---|
| ---------------------------- | --------- |
Device Name:
Indications for Use:
The DePuy ASR™ XL Modular Acetabular Cup System is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components:
-
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head and neck.
-
- Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty.
-
- Certain cases of ankylosis.
Porous-coated DePuy ASR™ XL Modular Acetabular Cups are indicated for cementless application.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(Please do not write below this line. Continue on another page if needed.)
| Concurrence of CDRH, Office (Division Sign-Off) (ODE) | |
|---|---|
| (Posted November 13, 2003) | |
| Division of General, Restorative and Neurological Devices | Page 1 of 1 |
| 510(k) Number | 1080997 |
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