(93 days)
Not Found
No
The document describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to alleviate pain and restore function in total hip arthroplasty, which are therapeutic goals.
No
This device is a prosthetic implant (hip replacement components) used in surgery, not a diagnostic tool. Its purpose is to alleviate pain and restore function, not to identify or characterize a disease.
No
The device description clearly describes physical components (cobalt chrome liner, polyethylene insert) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This is a surgical procedure performed on the body.
- Device Description: The device is described as a liner and insert made of materials like cobalt chrome and polyethylene, designed to articulate within an acetabular cup. These are physical implants.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
This device is an implantable medical device used in surgery, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The MDMIM liner and X30 Acetabular Inserts are a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis; 2)
- Correction of functional deformity; 3)
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5) femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
The MDM™ liners are intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
87 MEH, 87 LZO
Device Description
The Modular Dual Mobility (MDM™) liner is a highly polished cobalt chrome liner that features a Trident® locking mechanism. This feature will allow for compatibility with other acetabular cups containing the same locking mechanism. A Duration® or X3® polyethylene insert will articulate within the MDM™ liner. The additional X3® Acetabular Inserts are intended to accommodate the size range of the MDM™ liner device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
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)
Testing has been performed to demonstrate equivalence of the subject device compared Forming tas over pice. Predicate devices include Restoration® ADM System (K072020), to its predicate devices include Resert (K093644), and Trident® Porous Titanium Acetabular Component (K010170). The testing conducted includes disassembly force evaluation including push-out strength according to ASTM F1820-03 and lever-out and pull-out force testing. An engineering analysis of range of motion, jump distance, and fretting wear were also performed.
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.
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
FEB - 3 2011
Modular Dual Mobility (MDM™) Liner and Proprietary Name: 28 A cetabular Insert
510(k) Summary of Safety and Effectiveness
| X3° Acetabular Insert | |
|---|---|
| Common Name: | Artificial Hip Replacement Components - Acetabular |
| Classification Name | Hip joint metal/ceramic/polymer semi-constrained |
| cemented or nonporous uncemented prosthesis, 21 CFR | |
| §888.3353 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 MEH, 87 LZO |
| For Information contact: | Avital Merl-Margulies |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6365 Fax: (201) 831-3365 | |
| Date Prepared: | February 3. 2011 |
Description:
The Modular Dual Mobility (MDM™) liner is a highly polished cobalt chrome liner that features a Trident® locking mechanism. This feature will allow for compatibility with other acetabular cups containing the same locking mechanism. A Duration® or X3® polyethylene insert will articulate within the MDM™ liner. The additional X3® Acetabular Inserts are intended to accommodate the size range of the MDM™ liner device.
Intended Use:
The MDMIM liner and X30 Acetabular Inserts are a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. These devices are intended to be used only with currently available Howmedica Osteonics 22.2 mm and 28 mm diameter femoral heads.
Indications:
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis; 2)
- Correction of functional deformity; 3)
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1
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 5) femur with head involvement that are unmanageable using other techniques.
103233
-
- Dislocation risks
. "
- Dislocation risks
The MDM™ liners are intended for cementless use only.
Substantial Equivalence:
Testing has been performed to demonstrate equivalence of the subject device compared Forming tas over pice. Predicate devices include Restoration® ADM System (K072020),
to its predicate devices include Resert (K093644), and Trident® Porous Titanium Acetabular Component (K010170). The testing conducted includes disassembly force evaluation including push-out strength according to ASTM F1820-03 and lever-out and pull-out force testing. An engineering analysis of range of motion, jump distance, and fretting wear were also performed.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle's head, depicted with three stylized lines forming the head and beak. The eagle's head is facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corporation % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
FEB = 3 201
Re: K103233
Trade/Device Name: Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis
Regulatory Class: Class II Product Code: LZO, MEH Dated: January 28, 2011 Received: January 31, 2011
Dear Ms. Merl-Margulies:
the submit and the subject of the subject of
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. 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 vour 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Avital Merl-Margulies
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Aly B. R.
for.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
113233
510(k) Number (if known):
Device Name: Modular Dual Mobility (MDM™) liner and X3® Acetabular Insert
Indications for Use:
The indications for use of the total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis 2)
- Correction of functional deformity; 3)
- Revision procedures where other treatments or devices have failed; 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with 2) head involvement that are unmanageable using other techniques.
- Dislocation risks 6)
The MDM™ liners are intended for cementless use only.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103233