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 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

The MDM™ liners are intended for cementless use only.

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.

AI/ML Overview

This 510(k) summary describes the Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert, which are components for artificial hip replacement. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Mechanical Performance	Disassembly force evaluation (ASTM F1820-03)	Performed, demonstrating "equivalence of the subject device compared to its predicate devices."
	Push-out strength (ASTM F1820-03)	Performed, demonstrating "equivalence of the subject device compared to its predicate devices."
	Lever-out force testing	Performed, demonstrating "equivalence of the subject device compared to its predicate devices."
	Pull-out force testing	Performed, demonstrating "equivalence of the subject device compared to its predicate devices."
Biomechanical Performance	Range of motion	Engineering analysis performed.
	Jump distance	Engineering analysis performed.
	Fretting wear	Engineering analysis performed.
Material Compatibility	Not explicitly stated as a criterion, but inherent in the choice of materials (Cobalt Chrome, X3® polyethylene).	Implied to be acceptable through substantial equivalence to predicate devices.
Biocompatibility	Not explicitly stated as a criterion, but a standard requirement for implantable devices.	Implied to be acceptable through substantial equivalence to predicate devices.

Missing Information: The document states that testing was performed to "demonstrate equivalence" to predicate devices. However, it does not provide specific acceptance values (e.g., minimum push-out strength in Newtons) or the exact quantitative results achieved by the MDM™ Liner and X3® Acetabular Insert for the mechanical or biomechanical tests. The K103233 does not contain a formal "Clinical Study" section with detailed performance results against pre-defined acceptance criteria for the new device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not mentioned. The document primarily refers to "testing" and "engineering analysis" to demonstrate equivalence rather than a specific clinical or performance test set with a defined sample size. These tests are typically benchtop mechanical tests on a limited number of device samples.
Data Provenance: Not explicitly stated. For benchtop mechanical testing, the "provenance" would typically refer to the manufacturing batch or lot of the devices tested. It is not clinical data, so country of origin of patient data or retrospective/prospective status is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This information is relevant for studies involving human data and expert review (e.g., image interpretation, clinical outcome assessment). The provided document describes engineering and mechanical tests aimed at demonstrating equivalence to predicate devices, not clinical performance assessed by experts.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth in studies involving human assessment. This is not relevant to the engineering and mechanical tests described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not Applicable. This device is a hip implant component. The provided documentation does not involve Artificial Intelligence (AI) or human readers interpreting data. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not Applicable. This question pertains to AI algorithm performance. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical and engineering tests described would be the established scientific and engineering principles, material properties, and the performance characteristics of the predicate devices as defined by their own testing and regulatory clearance. For example, for push-out strength, the "ground truth" is a measurable force value, and the new device's performance is compared against that of the predicate to demonstrate equivalence.

8. The Sample Size for the Training Set

Not Applicable. This information is relevant for AI models, which require training data. This device is a physical implant.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. This information is relevant for AI models.

In summary: The provided 510(k) summary for the Modular Dual Mobility (MDM™) Liner and X3® Acetabular Insert focuses on demonstrating substantial equivalence through benchtop engineering and mechanical testing against a set of predicate devices. It does not provide detailed quantitative acceptance criteria or specific performance data in the context of a clinical study or a study directly addressing human performance or AI. Therefore, much of the requested information, which is typically found in clinical trial reports or AI/CADe system submissions, is not contained within this document.

Summary

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K103233

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-constrainedcemented or nonporous uncemented prosthesis, 21 CFR§888.3353
Proposed Regulatory Class:	Class II
Product Codes:	87 MEH, 87 LZO
For Information contact:	Avital Merl-MarguliesRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365 Fax: (201) 831-3365
Date Prepared:	February 3. 2011

Description:

Intended Use:

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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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

1. 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.

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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

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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

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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

Regulation Number and Section

§ 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.