(26 days)
No
The 510(k) summary describes a mechanical orthopedic implant (femoral heads for hip replacement) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a total hip replacement system, which is intended to increase patient mobility and reduce pain by replacing a damaged joint, thus providing a therapeutic benefit.
No
Explanation: The provided text describes the "DePuy Modular M Heads" which are components used in total hip replacement procedures. These are orthopedic implants designed to treat joint pain and improve mobility, not to diagnose medical conditions.
No
The device description clearly states the device is manufactured from wrought Co-Cr-Mo alloy and describes physical dimensions and materials, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the DePuy Modular M Heads are for use in total hip replacement procedures to replace a damaged hip joint articulation. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a physical component (femoral head) made of Co-Cr-Mo alloy, designed to articulate with other components within the hip joint.
- Lack of IVD characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DePuy Modular M Heads do not fit this description. They are implanted in vivo (inside the body).
Therefore, the DePuy Modular M Heads are a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
DePuy Modular M Heads are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, 4. internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.
Product codes
87 JDI and 87 LPH
Device Description
The subject DePuy Modular M Heads are manufactured from wrought Co-Cr-Mo alloy and are available in:
- 40, 44, and 48 mm diameters with a 12/14 Articul/eze taper and -- 2, +1.5, +5, . +8.5. +12 and +15.5 mm neck lengths. All of the Articul/eze taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
- 40 and 44 mm diameters with an 11/13 S-ROM taper and -3, +0, +3, +6, +9 . and +12 mm neck lengths. The 48 mm heads with the 11/13 S-ROM taper are available in +0, +3, +6, +9 and +12 mm neck lengths. All of the S-ROM taper
femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
The subject device is designed to articulate with the Pinnacle™ Marahon®" ES3 Liners (K033273) inside a Pinnacle™ Acetabular System shell (K033338) in cementless applications.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
DePuy ULTIMA Unipolar Femoral Heads: K033273, DePuy Articul/eze Femoral Heads: K980513, DePuy 36 mm Femoral Heads: K980513, K851422
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
JAN 3 ] 2006
K06003/ pacific
510(k) SUMMARY
| NAME OF FIRM: | DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581 |
|-----------------|------------------------------------------------------------------------------|
| 510(k) CONTACT: | Keli Hankee
Clinical Research Associate |
| TRADE NAME: | DePuy Modular M Heads |
| COMMON NAME: | Femoral Heads |
CLASSIFICATIONS:
888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
DEVICE PRODUCT CODES:
87 JDI and 87 LPH
SUBSTANTIALLY EQUIVALENT DEVICES:
- DePuy ULTIMA Unipolar Femoral Heads: K033273 (submitted as Pinnacle™ . Acetabular System)
- DePuy Articul/eze Femoral Heads: K980513 .
- DePuy 36 mm Femoral Heads: K980513, K851422 (cleared through internal . documentation.)
DEVICE DESCRIPTION AND INTENDED USE:
The subject DePuy Modular M Heads are manufactured from wrought Co-Cr-Mo alloy and are available in:
- 40, 44, and 48 mm diameters with a 12/14 Articul/eze taper and -- 2, +1.5, +5, . +8.5. +12 and +15.5 mm neck lengths. All of the Articul/eze taper femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
- 40 and 44 mm diameters with an 11/13 S-ROM taper and -3, +0, +3, +6, +9 . and +12 mm neck lengths. The 48 mm heads with the 11/13 S-ROM taper are available in +0, +3, +6, +9 and +12 mm neck lengths. All of the S-ROM taper
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Ko/003/ page 272
femoral heads have an internal taper that mate with a corresponding external taper on compatible cemented or cementless femoral stems (Exhibit III).
The subject device is designed to articulate with the Pinnacle™ Marahon®" ES3 Liners (K033273) inside a Pinnacle™ Acetabular System shell (K033338) in cementless applications.
DePuy Modular M Heads are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from 1. osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, 4. internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.
BASIS OF SUBSTANTIAL EQUIVALENCE:
Based on design, method of manufacture, intended use, available diameter and indication, the subject device is found to be substantially equivalent to the comparison device, K033273.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JAN 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Keli K. Hankee Clinical Research Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K060031 Re:
Trade/Device Name: DePuy Modular M Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Regulatory Class: Class II
Product Code: LPH, JDI Dated: January 4, 2006 Received: January 5, 2006
Dear Ms. Hankee:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner or prior to ria) 20, 20, 2017 11:27 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmotio Free (. Iot (. Iot) the device, subject to the general controls provisions of the Act. The 1 ou may, after systems 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 rnean 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
3
Page 2 – Ms. Keli K. Hankee
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) 594-4639. 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 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,
Z
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K060031
Device Name: DePuy Modular M Head
Indications for Use:
DePuy Modular M Heads are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
-
- 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 or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The DePuy Modular M Heads are indicated for use with the Pinnacle® Acetabular Cup in cementless application.
Prescription Use X
AND/OR Over-The-Counter Use Ne
(Title 21 CFR Part 801 Subpart D)
(Title 21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KO60031 510(k) Number_