(514 days)
No
The device description focuses on the materials and mechanical components of a hip replacement system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in total hip replacement procedures to alleviate severe pain and disability due to structural damage in the hip joint, which is a therapeutic purpose.
No.
The device is described as a system for total hip replacement procedures, specifically focusing on the components (acetabular cup, femoral head, and taper sleeve adapter) that replace damaged hip joint structures. Its intended use is for treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components made of metal alloys (acetabular cup, femoral head, taper sleeve adapter), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The DePuy ASR™ Modular Acetabular Cup System is a surgical implant designed to replace a damaged hip joint. It is a physical device implanted into the body during a surgical procedure.
- Intended Use: The intended use is for total hip replacement procedures to address structural damage in the hip joint. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates a medical device used in surgery, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The DePuy ASR™ Modular Acetabular Cup System is indicated for use 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 nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Product codes
87 KWA
Device Description
The DePuy ASR™ Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter.
The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy onepiece cup with Porocoat® porous coating and is available in outer diameter sizes 44mm through 62mm 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.
The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy The femoral heads articulate with corresponding one-piece metal 12/14 or 11/13 tapers. acetabular cups.
The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima" Unipolar Head and Adapter Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12.
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)
DePuy Pinnacle® Metal-on-Metal Acetabular Cup Line (K002883 & K003523), Wright Medical Metal TRANSCEND® Articulation System (K021349), DePuy Ultima® Unipolar Head and Adapter Sleeves (K965156)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K040627
- AUG 5 2005
510(k) Summary
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
PO Box 988
700 Orthopaedics
Warsaw, IN 46581-0988 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Natalie Heck
Manager, Regulatory Affairs |
| TRADE NAME: | DePuy ASRTM Modular Acetabular Cup System |
| COMMON NAME: | Femoral Hip Prosthesis |
| CLASSIFICATION: | Class III per 21 CFR 888.3330 Hip Joint
metal/metal semiconstrained, with an uncemented
acetabular component prosthesis |
| DEVICE PRODUCT CODE: | 87 KWA |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy Pinnacle® Metal-on-Metal Acetabular Cup
Line (K002883 & K003523)
Wright Medical Metal TRANSCEND® Articulation
System (K021349)
DePuy Ultima® Unipolar Head and Adapter Sleeves
(K965156) |
DEVICE DESCRIPTION:
The DePuy ASR™ Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter.
The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy onepiece cup with Porocoat® porous coating and is available in outer diameter sizes 44mm through 62mm 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.
The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy The femoral heads articulate with corresponding one-piece metal 12/14 or 11/13 tapers. acetabular cups.
The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima" Unipolar Head and Adapter
1
K040627 (pg 2 of 2)
Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12.
INDICATIONS FOR USE:
The DePuy ASR™ Modular Acetabular Cup System is indicated for use 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 nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
BASIS OF SUBSTANTIAL EQUIVALENCE:
DePuy believes the DePuy ASR™ Modular Acetabular Cup System to be substantially equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners; the Wright Medical Metal TRANSCEND Articulation System; and the DePuy Ultima Adapter Sleeves based upon the similarities in design, material composition, and intended use/indications for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988
Re: K040627
Trade/Device Name: DePuy ASRTM 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: III Product Code: KWA Dated: May 23, 2005 Received: May 24, 2005
AUG 5 - 2005
Dear Ms. Heck:
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. Iisting 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 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.
3
Page 2 -- Ms. Natalie Heck
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) 276-0210. 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 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/industry/support/index.html.
Sincerely yours,
Hupfhurdu
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ h040627 510(K) Number (II Known): "ITV
Device Name: DePuy ASR ™ Modular Acetabular Cup System
Indications for Use:
The DePuy ASR™ Modular Acetabular Cup System is indicated for use in 101aLhip replacement The Del as for patients suffering severe pain and disability due to structural damage in the hip joint from theumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, John "Hour" thoumatord" and nonunion of femoral fractures. Use of the prosthesis is also indicated for a valients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Over-The-Counter Use Prescription Use 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)
Page 1 of 1
(Posted November 13, 2003)
Hypl Rurlis
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KO 40627 519(k) Number