(26 days)
The modification does not alter the intended use of the predicate systems as cleared in the referenced premarket notifications. The subject ADM and ADM/MDM Acetabular Inserts are sterile, single-use devices 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 necrosis: l )
-
- 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
The ADM and MDM Systems are intended for cementless use only.
The Restoration® Anatomic Dual Mobility (ADM) and Modular Dual Mobility (MDM) Systems utilize Duration® and X3® Polyethylene Acetabular Inserts that retain a femoral head. The outer diameter of the insert articulates on the inner surface of either the polished ADM Acetabular Cup or, for certain sizes of inserts, the MDM Acetabular Liner. The Duration® and X30 polyethylene inserts therefore function as a dual mobility device as there are two articulating surfaces.
The provided submission is a 510(k) summary for the Restoration® Anatomic Dual Mobility™ and Modular Dual Mobility™ Systems Duration® and X3® Acetabular Inserts. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical trials. Therefore, much of the requested information cannot be extracted from this document as it pertains to clinical study results.
Here's a breakdown of what can be inferred and what cannot:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices through engineering and risk analysis, and laboratory testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices in intended use, materials, and performance characteristics. | Demonstrated through: - Device comparison (intended use, materials, operational principles) - Engineering and risk analysis - Laboratory testing (Wear, lever-out and pull out force testing, and range of motion analysis) |
2. Sample size used for the test set and the data provenance
The document states: "Clinical Testing: Clinical testing was not required for this submission." This indicates there was no clinical "test set" in the context of a traditional clinical study with human subjects. The "test set" for demonstrating substantial equivalence consisted of laboratory tests on the device itself.
- Sample Size: Not specified as it refers to laboratory testing, not human subjects.
- Data Provenance: Laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no clinical ground truth established by experts for a patient test set as clinical testing was not performed.
4. Adjudication method for the test set
Not applicable, as there was no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an orthopedic implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
For the laboratory testing, the "ground truth" would be the measured physical and mechanical properties of the device, compared against known industry standards, design specifications, and the performance of predicate devices. This is a technical "ground truth" rather than a clinical one.
8. The sample size for the training set
Not applicable. There was no "training set" in the context of machine learning. The design and validation of the device were based on engineering principles and knowledge, not data-driven training.
9. How the ground truth for the training set was established
Not applicable. Without a training set, this question is not relevant.
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112 556 1/2
SEP 2 8 2011 510(k) Summary of Safety and Effectiveness: Restoration® Anatomic Dual Mobility™ and Modular Dual Mobility™ Systems Duration® and X3® Acetabular Inserts
| Proprietary Name: | Restoration® Anatomic Dual Mobility™ (ADM)and Modular DualMobility™ (MDM) Systems Duration® and X3® Acetabular Inserts |
|---|---|
| Common Name: | Artificial Hip Replacement Components - Acetabular |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis, 21 CFR §888.3353 |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87 MEH, 87 LZO |
| For Information contact: | Valerie GiambancoRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6275 Fax: (201) 831-3275 |
| Date Prepared: | 9/1/2011 |
Description:
The Restoration® Anatomic Dual Mobility (ADM) and Modular Dual Mobility (MDM) Systems utilize Duration® and X3® Polyethylene Acetabular Inserts that retain a femoral head. The outer diameter of the insert articulates on the inner surface of either the polished ADM Acetabular Cup or, for certain sizes of inserts, the MDM Acetabular Liner. The Duration® and X30 polyethylene inserts therefore function as a dual mobility device as there are two articulating surfaces.
Intended Use:
The modification does not alter the intended use of the predicate systems as cleared in the referenced premarket notifications. The subject ADM and ADM/MDM Acetabular Inserts are sterile, single-use devices 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.
{1}------------------------------------------------
112556 2/2
Indications for Use:
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis: l )
-
- 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
The ADM and MDM Systems are intended for cementless use only.
Devices for which Substantial Equivalence is claimed:
- Howmedica Osteonics Restoration® ADM System: K072020 .
- Howmedica Osteonics Restoration® ADM X3® Acetabular Insert: K093644 .
- Howmedica Osteonics Restoration MDM System: K 103233 .
Proposed Modification:
The subject ADM Inserts and ADM/MDM Inserts maintain the same indications for and intended use, material, and operational principles as the previously cleared ADM/MDM Acetabular Inserts, cleared for use with ADM under K072020 and K093644, and certain sizes cleared for use with MDM under K 103233. The subject ADM insert and ADM/MDM Insert devices consist of a modification to their inner bore design.
Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device. Device comparison showed that the modified device is substantially equivalent in intended use, materials and performance characteristics to the predicate device. Engineering and risk analysis has been performed to demonstrate equivalence of the subject products to the predicate devices. Laboratory testing was performed for the hip system to determine substantial equivalence. Wear, lever-out and pull out force testing, and range of motion analysis have been established for the modified design.
Clinical Testing: Clinical testing was not required for this submission.
Conclusion: The ADM Inserts and ADM/MDM Inserts are substantially equivalent to the predicate devices identified in this premarket notification.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, representing growth and vitality. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Valerie Giambanco 325 Corporate Drive Mahwah, NJ 07430
2 8 2011
Re: K112556
Trade/Device Name: Restoration® Anatomic Dual Mobility™ (ADM) and Modular Dual Mobility™ (MDM) Systems Duration® and X3® Acetabular Inserts Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: MEH. LZO Dated: September 1.51, 2011 Received: September 2"d. 2011
Dear Ms. Giambanco:
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 10 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
{3}------------------------------------------------
Page 2 - Ms. Valerie Giambanco
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 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 331-542 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k)
Indications for Use
K112556 510(k) Number (if known):
Device Name: ADM and ADM/MDM Acetabular Inserts
Indications for Use:
The indications for use for total hip arthroplasty include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular l) 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 5) femur with head involvement that are unmanageable using other techniques.
-
- Dislocation risks
The ADM and MDM Systems are intended for cementless use only.
Prescription Use 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Oft)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number 112556
to MXM
§ 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.