(23 days)
87 MEH, 87 LZO
Not Found
No
The document describes a mechanical implant (acetabular insert) and its intended use and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to alleviate pain and restore function, and is used in procedures for degenerative joint diseases and correcting functional deformities.
No
This device is an acetabular insert used in hip replacement surgery to alleviate pain and restore function. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a physical component (acetabular insert) of a total hip system, made of polyethylene, and intended for surgical implantation. It is not software.
Based on the provided text, 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 about a person's health.
- Device Description: The description clearly states the device is an "Acetabular Insert," a component of a total hip replacement system. It is a physical implant used in surgery to replace a damaged joint surface.
- Intended Use: The intended use is for "primary and revision total hip arthroplasty to alleviate pain and restore function." This is a surgical procedure, not a diagnostic test performed on a specimen.
- Lack of Diagnostic Language: The text does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the Restoration® ADM system X3® Acetabular Insert is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Restoration® ADM system X3® Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28 mm diameter femoral heads.
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- Dislocation risks
This acetabular cup is intended for cementless use only.
Product codes
87 MEH, 87 LZO
Device Description
The Restoration® Anatomic Dual Mobility (ADM) System X3® Acetabular Insert is a component of the Restoration® ADM System. The Restoration® ADM X3® Acetabular Insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.
The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, failure of other levices, or trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, acetabulum, 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
A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. The testing includes material properties characterization, hip simulated wear testing, and disassembly force evaluation.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 8 2009
510(k) Summary of Safety and Effectiveness: Restoration® ADM System %3® Acetabular Insert
| Proprietary Name: | Restoration® ADM System X3® Acetabular Insert |
|---|---|
| Common Name: | Artificial Hip Replacement Components - Acetabular |
| Classification Name and Reference: | 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 Associate | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6365 Fax: (201) 831-3365 | |
| Date Prepared: | November 18, 2009 |
Description:
The Restoration® Anatomic Dual Mobility (ADM) System X3® Acetabular Insert is a component of the Restoration® ADM System. The Restoration® ADM X3® Acetabular Insert retains a femoral head. The outer diameter of the insert articulates on the inner surface of the polished metal acetabular cup. The polyethylene insert therefore functions as a bipolar head as there are two articulating surfaces.
Intended Use:
The Restoration® ADM system X3® Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used only with any currently available Howmedica Osteonics 28 mm diameter femoral heads.
p. 1 of 2
1
. Indications:
-: The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1)
-
- Rheumatoid arthritis:
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed;
- : 2) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- () Dislocation risks
This acetabular cup is intended for cementless use only.
Proposed Modification:
Addition of new polyethylene components of a modified sequentially crosslinked and annealed material which has undergone a STERRAD gas plasma sterilization.
Device Description:
The device includes the acetabular inserts of a total hip system. These components are used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, failure of other levices, or trauma.
Summary of Data:
A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices. The testing includes material properties characterization, hip simulated wear testing, and disassembly force evaluation.
p. 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
DEC 1 8 2009
Re: K093644
Trade/Device Name: Restoration® ADM System 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: MEH, LZO Dated: November 24, 2009
Received: November 25, 2009
Dear Ms. Merl-Margulies:
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.
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 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,
Jonetta Jr
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k)
Indications for Use
510(k) Number (if known): kof 36 YY
Device Name: Restoration® ADM System X3® Acetabular Insert
Indications for Use:
The indications for use of the total hip arthroplasty include:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
- Rheumatoid arthritis
-
- Correction of functional deformity;
-
- Revision procedures where other treatments or devices have failed,
- ર) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- () Dislocation risks
This acetabular cup is intended for cementless use only.
Prescription Use X Over-The-Counter 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)
vision Sion of
Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093644
41