(87 days)
No
The 510(k) summary describes a mechanical implant for hip replacement and contains no mention of AI, ML, image processing, or performance studies related to algorithmic output.
Yes
The device is indicated for use in the treatment of severely painful and/or disabled joints, avascular necrosis, acute traumatic fracture, failed previous surgeries, and ankylosis, and is part of a total hip arthroplasty, which are all therapeutic interventions designed to alleviate symptoms, restore function, or correct anatomical issues.
No
The device is an orthopedic implant for joint replacement, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "modular prosthesis system for use in total hip replacement" and is a physical component ("mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups"). This indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes the DePuy aSphere M-Spec Head as a component of a total hip replacement prosthesis. It is surgically implanted to treat conditions affecting the hip joint.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical, replacing a damaged joint.
Therefore, based on the provided information, the DePuy aSphere M-Spec Head is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip arthroplasty.
The DePuy aSphere M-Spec Head is indicated for use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Product codes
87 KWA, 87 JDI, 87 LPH
Device Description
The aSphere M-Spec Head is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head
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)
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
K082585 pg 1/2
510 (k) Summary
Name of Sponsor:
510(k) Contact:
Manufacturer:
Contract Sterilizer:
Date Prepared: Proprietary Name: Common Name: Classification:
Device Product Codes:
Substantially Equivalent Devices:
(As required by 21 CFR 807.92 and 21 CFR 807.93)
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910
Rhonda Myer Regulatory Affairs Associate Telephone: (574) 371-4927 Facsimile: (574) 371-4987 Electronic Mail: Rinyer7(@)its.jnj.com
DePuy International St. Anthony's Road Beeston Leeds United Kingdom LS11 8DT
Swann-Morton Ltd. Owlerton Green Sheffield S6 2BJ United Kingdom
December 2, 2008
DePuy aSphere M-Spec Head
Modular Femoral Head
Class III per 21 CFR 888.3330: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis
Class II per 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis
Class II per 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis
87 KWA, 87 JDI, and 87 LPH
DePuy M-Spec Head 36 mm: K980513 and internal documentation to K851422 40 mm and 44 mm: K060031
1
K082585 pg 2/2
Device Description:
The aSphere M-Spec Head is part of a modular prosthesis system for use in total hip replacement. It mates with DePuy femoral stems and articulates with DePuy acetabular inserts and cups.
Indications for Use:
The DePuy aSphere M-Spec Head is indicated for use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
-
- Certain cases of ankylosis.
Intended Use:
The subject aSphere M-Spec Head is intended for use as part of the femoral component in a total hip arthroplasty.
Basis of Substantial Equivalence:
Based on the similarities in intended use, indications for use, materials, design, method of manufacture, sterilization and packaging methods, DePuy believes the subject aSphere M-Spec Head is substantially equivalent to the previously cleared DePuy M-Spec Head, cleared in K980513, internal documentation to K851422, and K060031.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Rhonda Myer Regulatory Affairs Associate 700 Orthopaedic Dr. Warsaw, Indiana 46581
DEC 0 4 2008
Re: K082585
Trade/Device Name: DePuy aSpehere M-Spec Head 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, JDI, LPH Dated: November 5, 2008
Received: November 6, 2008
Dear Ms. Myer:
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 for use saled in the enactment date of the enactment date of the Medical Device Amendments, or to conninered price to may 2008sified 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 I ou may, dicrerere, mains 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 or any I cocial suttated and regisments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY at 607); intoning (21 CFR 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. Rhonda Myer
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5.10 (k) Number (if known): YOB2585 (pay) / 1)
Device Name: DePuy aSphere M-Spec Head
Indications for Use:
The DePuy aSphere M-Spec Head is indicated for use in the treatment of:
-
- A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis, or congenital hip'dysplasia;
-
- Avascular necrosis of the femoral head;
-
- Acute traumatic fracture of the femoral head or neck;
-
- Failed previous surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthoplasty, or other total hip replacement; and
- Certain cases of ankylosis. న.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Posted November 13, 2003) age 1 of 1 (Division 3155) Division of General, Restorative,
DePuy Orthopaedics, Inc.
and Neurological Devices
Page 10 of 107
510(k) Number _ K of 2585