(427 days)
No
The summary describes a line extension of physical femoral heads with different taper sizes and offsets. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on dimensional analysis of physical components.
Yes
The device, a line of femoral heads for total hip replacement, is a therapeutic device because its intended use is to treat severely painful and/or disabled joints, avascular necrosis, acute traumatic fractures, and failed previous hip surgeries as part of a total hip replacement procedure. These conditions indicate the device's role in alleviating pain, restoring function, or repairing damaged anatomical structures.
No
The device described is a femoral head for hip replacement surgery, which is an implantable medical device used in treatment, not for diagnosis.
No
The device description clearly states the devices are "a line extension to the existing range of Articul/Eze 36mm Femoral Heads" and describes physical components like "taper sizes and offsets." This indicates a hardware medical device, not a software-only one.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a femoral head, which is a component of a total hip replacement. This is an implantable medical device used in surgery to replace a damaged hip joint.
- Intended Use: The intended use clearly states the conditions for which a total hip replacement is indicated, all of which relate to the physical condition of the hip joint itself, not the analysis of bodily specimens.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
LPH, JDI
Device Description
The subject devices are a line extension to the existing range of Articul/Eze 36mm Femoral Heads and represent additional taper sizes and offsets to allow surgeons more flexibility in the choice of femoral hip stem. Specifically, the tapers include 12/14 Articul/Eze taper with +15.5mm offset, 11/13 S-ROM taper with -3mm, 0mm, +3mm, +6mm, +9mm and 12mm offsets, and 14/16 taper with 0mm, +3mm, +5mm, +8mm and +11mm offsets. The tapers are designed to mate with femoral hip stems which have matching neck taper sizes. The offsets vary to allow the surgeon flexibility in lateralization of the hip joint.
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)
Dimensional analysis of femoral heads included in K980513, K060031, K880269, and K082585 compared to the subject devices was conducted to show substantial equivalence.
No clinical testing was required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K980513, K060031, K082585, K880269
Reference Device(s)
Not Found
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
Section 5: 510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
APR 3 0 2013
.
| Submitter Information | |
|---|---|
| Name | DePuy Orthopaedics, Inc. |
| Address | 700 Orthopaedic Drive, Warsaw, IN 46582 |
| Phone number | (574) |
| Fax number | (574) 371-4987 |
| Establishment | |
| Registration | |
| Number | 1818910 |
| Name of | |
| contact person | Correne Ramy |
| Date prepared | February 27, 2013 |
| Name of device | |
| Trade or | |
| proprietary | |
| name | DePuy M-Spec 36mm Femoral Heads |
| Common or | |
| usual name | Femoral heads |
| Classification | |
| name | Hip joint metal/polymer/metal, semi-constrained, porous-coated, uncemented |
| prosthesis | |
| Hip joint metal/polymer, semi-constrained cemented prosthesis | |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3358 and 21 CFR 888.3350 |
| Product Code(s) | LPH, JDI |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | 36mm Articul/eze Femoral Heads (K980513, cleared April 14, 1998) |
| DePuy M-Spec Femoral Heads (K060031, cleared January 31, 2006) | |
| DePuy LCS Femoral Hip Prosthesis (K880269, cleared May 6, 1988) | |
| DePuy ASphere M-Spec Femoral Heads (K082585, cleared December 4, 2008) | |
| Reason for 510(k) | |
| submission | Line extension |
| Device description | The subject devices are a line extension to the existing range of Articul/Eze 36mm |
| Femoral Heads and represent additional taper sizes and offsets to allow surgeons more | |
| flexibility in the choice of femoral hip stem. Specifically, the tapers include 12/14 | |
| Articul/Eze taper with +15.5mm offset, 11/13 S-ROM taper with -3mm, 0mm, +3mm, | |
| +6mm, +9mm and 12mm offsets, and 14/16 taper with 0mm, +3mm, +5mm, +8mm | |
| and +11mm offsets. The tapers are designed to mate with femoral hip stems which | |
| have matching neck taper sizes. The offsets vary to allow the surgeon flexibility in | |
| lateralization of the hip joint. | |
| Intended use of the | |
| device | Total hip arthroplasty |
1
K120599 (Page 2 of 2) Total hip replacement is indicated in the following conditions: Indications for use A severely painful and/or disabled joint from osteoarthritis, traumatic l . arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. Failed previous hip surgery including joint reconstruction, internal 4. arthrodesis, hemiarthroplasty, surface replacement fixation, arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications Summary of the technological characteristics of the device compared to the predicate device Characteristic | DePuv M-Spec 36mm | Modular M-Spec | ASphere M-LCS
| | DePuy M-Spec
36mm Femoral
Heads | 36mm
Articul/eze
Femoral
Heads
(K980513) | Modular M-Spec
Femoral Heads
(K060031) | Aspire M-
Spec Femoral
Heads
(K082585) | LCS
Femoral Hip
Prosthesis
(K880269) |
|--------------------------|---------------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------|
| Material | Cobalt-chromium-
molybdenum | Cobalt-
chromium-
molybdenum | Cobalt-chromium-
molybdenum | Cobalt-
chromium-
molybdenum | Cobalt-
chromium-
molybdenum |
| Head diameter | 36mm | 36mm | 40, 44, 48mm | 36, 40, 44mm | 32mm |
| Offsets (taper
style) | +15.5mm (12/14)
-3, +0, +3, +6, +9,
+12mm (11/13)
+0, +3, +5, +8,
+11mm (14/16) | -2, +1.5, +5,
+8.5, +12mm
(12/14) | -2, +1.5, +5, +8.5,
+12, +15.5mm
(12/14)
-3, +0, +3, +6, +9,
+12mm (11/13) | -2, +1.5, +5,
+8.5, +12,
+15.5mm
(12/14)
-3, +0, +3, +6,
+9, +12mm
(11/13) | +0, +5, 11mm
(14/16) |
| Sterilization
Method | Gamma radiation | Gamma radiation | Gamma radiation | Gamma radiation | Gamma radiation |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Dimensional analysis of femoral heads included in K980513, K060031, K880269, and K082585 compared to the subject devices was conducted to show substantial equivalence.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
No clinical testing was required to demonstrate substantial equivalence.
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) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem, consisting of a symbol that resembles a caduceus or a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 30, 2013
DePuy Orthopaedics, Inc. % Ms. Correne Ramy Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582
Re: K120599
Trade/Device Name: DePuy M-Spec 36mm Femoral 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: February 25, 2013 Received: March 4, 2013
Dear Ms. Ramy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Correne Ramy
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N.Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
K120599 510 (k) Number (if known):
Device Name: DePuy M-Spec 36mm Femoral Heads
Indications for Use:
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.
| 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.)
| DOD-DIVISION SIGN-OFF | |
|---|---|
| Division of Orthopedic Devices | Elizabeth L. Frank - S |
| 510(k) Number: | K120599 |