Non inflammatory or rheumatoid arthritis;
Osteonecrosis of femoral head;
Hip deformity affecting its function;
Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques;
Revision of previous hip surgery;
Dislocation risks (e.g., ASA score ≥ 3)

The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Device Description

The TREGOR® Dual Mobility Acetabular System includes the acetabular components of a total hip prosthesis. Its design is based on the original 1976 Dual Mobility design developed by Prof. Bousquet: it uses two distinct articulating surfaces. The TREGOR® Dual Mobility Acetabular System is composed of a metal acetabular cup/shell and a dual mobility polyethylene insert. The articulating surfaces are: between the cup and the dual mobility insert, and between the dual mobility insert and the femoral head. The acetabular cup is made of wrought high nitrogen stainless steel (M30NW) for the cemented cup design (TREGOR® Medial Cup) and of Cobalt/Chromium alloy for all other cementless cup designs that are intended for a press-fit application. When used with cement, an acetabular reinforcement accessory with screws may also be used. When used without cement, the cup may include additional fixation aids (screws, pegs, blades) and includes a non-porous double coating. The plasma spray coating is made of pure titanium and hydroxyapatite (Ti/HA). The insert is made of ultra-high-molecular-weight polyethylene (UHMWPE).

There are five configurations of acetabular cups covering a wide range of sizes with dual mobility inserts compatible with 28 mm prosthetic femoral heads made of CrCo or ceramic:

TREGOR® Standard (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application.
TREGOR® 3 Blades (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades provide additional fixation.
TREGOR® + (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades and screws provide additional fixation.
TREGOR® Tripod (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Pegs and screw provide additional fixation.
TREGOR® Medial Cup (5 sizes from 52 to 60 mm outer diameter): for cemented use only. An optional acetabular reinforcement cross is for cemented use only.

The device is single use and provided sterile.

This premarket notification does not include the femoral components. The TREGOR® Dual Mobility Acetabular System is compatible with FDA cleared StelKast femoral components: Provident, Protract and Progeny femoral stems with the femoral heads made of cobalt-chromium and ceramics, listed below. The femoral heads fully cover the morse taper of the femoral stem neck and the stems all have a polished, highly polished or electro-polished neck:

Prosthetic head made of Cobalt-Chromium: 28 mm (StelKast reference SC1151: -5 mm, -3.5 mm, standard and +3.5 mm offset)
Biolox Delta Femoral head: 28 mm (StelKast reference SC3347, -3.5 mm, standard and +3.5 mm offset)

AI/ML Overview

The provided text describes a 510(k) summary for the TREGOR Dual Mobility Acetabular System, which is a hip prosthesis. The information focuses on demonstrating substantial equivalence to predicate devices and presents results from pre-clinical performance testing.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All acceptance criteria were met" for a series of pre-clinical tests. However, it does not provide specific numerical acceptance criteria for each test, nor does it present specific measured performance values for the device. Instead, it offers a list of tests conducted.

Test Conducted	Acceptance Criteria	Reported Device Performance
Dimensional and sizes analysis	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Static test of dual mobility insert dislocation pull-out	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Static test of dual mobility insert dislocation lever out	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Static and fatigue loading testing of the acetabular cup	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Range of motion analysis	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Jump distance analysis	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Holding of cemented cup under flexion and torsion loading	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Axial holding of tripod peg under loading	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Wear of polyethylene of dual mobility insert	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."
Dual Titanium and Hydroxyapatite coating characterization	Not specified (implied to meet predetermined specifications)	"All acceptance criteria were met." Concluded that the "finished product and its components met all pre-determined specifications and are adequate for their intended use."

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

The document states that "Pre-clinical performance testing was conducted in accordance with various international standards and FDA guidance documents." However, it does not specify the sample size used for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective/prospective). Given the nature of pre-clinical testing for medical implants, the "data provenance" would typically be a laboratory setting rather than patient data.

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

This information is not applicable as the evaluation relies on pre-clinical, mechanical, and material testing rather than expert-derived ground truth from clinical images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on pre-clinical, mechanical, and material testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data were not required for this device." This implies that the device's equivalence and safety/effectiveness were demonstrated through pre-clinical testing and comparison to predicate devices, without human-in-the-loop performance studies.

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

This question is not applicable to this device. The TREGOR® Dual Mobility Acetabular System is a physical medical device (hip prosthesis), not a software algorithm or AI. Therefore, the concept of "standalone algorithm performance" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications and established international standards for implantable medical devices. Rather than expert consensus, pathology, or outcomes data (which would be clinical), the performance is evaluated against predefined parameters for mechanical strength, wear, dimensions, material properties, and stability.

8. The Sample Size for the Training Set

This information is not applicable. The TREGOR® Dual Mobility Acetabular System is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable. As stated above, the device is not an AI/ML model and therefore does not have a "training set."

Summary

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12<2012

SECTION 5: 510(k) Summary

(111981

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92

Submitted by:

Prepared By/Contact Person:

Aston® Medical 19, rue Victor Grignard Zone Industrielle de Montreynaud 42000 Saint-Etienne France

Catherine Gloster, M.Sc., RAC Regulatory Consultant Gloster Biomedical International 577 North Hope Ave Santa Barbara, CA 93110 - USA Phone: 805-679-1258 Fax: 805-682-1250 Email: c.gloster@GlosterBiomedical.com

Date Prepared:

September 21, 2012

Proprietary Name:

Common Name:

TREGOR® Dual Mobility Acetabular System

Metal back acetabular cup with dual mobility insert

Class II, 21 CFR 888.3353 / 888.3358 / 888.3350 Classification: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis

Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Hip joint metal/polymer semi-constrained cemented prosthesis LZO / MEH / LPH / JDI

Predicate Devices:

K070278	Plus Orthopedics AG, USA - POLARCUP® Dual Mobility System-
	cleared 04/16/2007
K072020	Stryker®, Inc. (formerly Howmedica Osteonics Corp.) - Restoration
	ADM X3® Mobile Bearing™ Hip System - cleared 10/18/2007
K083116	Medacta International, SA. USA - Versafit Cup Double Mobility System
	- cleared 04/07/2009

TREGOR® Dual Mobility Acetabular System

Section S

Appendix 2 - Page 1

Supplement #2 TREGOR® Dual Mobility Acetabular System

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KIII981

p. 2/4

Biomet Manufacturing Corp., E1® Active Articulation Dual Mobility Hip K101336 System - cleared 01/14/2011

K092198 Corin USA - Cormet Cementless Resurfacing Femoral Head

Pre-Medical Device Amendment to Food, Drug and Cosmetic Act of 1976 - Charnley design acetabular cup

Device Description:

There are five configurations of acetabular cups covering a wide range of sizes with dual mobility inserts compatible with 28 mm prosthetic femoral heads made of CrCo or ceramic:

TREGOR® Standard (6 sizes from 52 to 62 mm outer diameter): Ti/HA . coating, cementless and press fit application.
. TREGOR® 3 Blades (6 sizes from 52 to 62 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades provide additional fixation.
. TREGOR® + (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Blades and screws provide additional fixation.
. TREGOR® Tripod (7 sizes from 52 to 64 mm outer diameter): Ti/HA coating, cementless and press fit application. Pegs and screw provide additional fixation.
. TREGOR® Medial Cup (5 sizes from 52 to 60 mm outer diameter): for cemented use only. An optional acetabular reinforcement cross is for cemented use only.

The device is single use and provided sterile.

K111981 TREGOR® Dual Mobility Acetabular System Section 5

K111981 - Supplement #2 TREGOR® Dual Mobility Acetabular System Appendix 2 - Page 2

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taper of the femoral stem neck and the stems all have a polished, highly polished or electro-polished neck:

K111981

Prosthetic head made of Cobalt-Chromium: 28 mm (StelKast reference . SC1151: -5 mm, -3.5 mm, standard and +3.5 mm offset)
Biolox Delta Femoral head: 28 mm (StelKast reference SC3347, -3.5 mm, . standard and +3.5 mm offset)

Indication for Use:

The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR):

. Non inflammatory or rheumatoid arthritis;
. Osteonecrosis of femoral head;
. Hip deformity affecting its function;
. Non-union head fracture or complex pertrochanteric fracture that are unmanageable using other techniques;
. Revision of previous hip surgery;
. Dislocation risks (e.g., ASA score ≥ 3)

The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Method of fixation:

When used with the TREGOR® Standard acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application.

When used with the TREGOR® with Blades acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® with Blades acetabular cup has blades for additional fixation.

When used with the TREGOR® + acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® + acetabular cup has blades and screws for additional fixation.

When used with the TREGOR® Tripod acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application. The TREGOR® Tripod acetabular cup has pegs and screw for additional fixation.

When used with the TREGOR® Medial Cup acetabular cup, the TREGOR® Dual Mobility Acetabular System is for cemented use only. An optional acetabular reinforcement cross maybe be used with the TREGOR® Medial Cup, also for cemented use only.

Section 5

K111981 - Supplement #2 TREGOR® Dual Mobility Acetabular System

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KII)981

p.4/4

Basis for substantial equivalence:

The TREGOR® Dual Mobility Acetabular System is substantially equivalent to the previously cleared devices: Plus Orthopedics POLARCUP® Dual Mobility System (K070278), Stryker® Restoration™ ADM X3® Mobile Bearing Hip™ System (K072020), Medacta Versafit® Cup Double Mobility (K083116), Biomet E1™ Active Articulation Dual Mobility Hip System (K101336), and the pre-1976 Medical Device Amendment to the Food. Drug and Cosmetic act device called the Charnley acetabular cup. The coating of the TREGOR® Dual Mobility Acetabular System is the same as the coating used on the previously cleared device Cormet Cementless Resurfacing Femoral Head (K092198). The assessment for substantial equivalence is based on similarities in indications for use, materials, dimensions, design, packaging and sterilization processes and results of pre-clinical testing. The subject device does not raise any new issues of safety and effectiveness.

Performance Data:

Pre-clinical performance testing was conducted in accordance with various international standards and FDA guidance documents. The following tests were conducted:

Dimensional and sizes analysis ●
. Static test of dual mobility insert dislocation pull-out
. Static test of dual mobility insert dislocation lever out
Static and fatigue loading testing of the acetabular cup .
. Range of motion analysis
Jump distance analysis .
. Holding of cemented cup under flexion and torsion loading
. Axial holding of tripod peg under loading
. Wear of polyethylene of dual mobility insert
. Dual Titanium and Hydroxyapatite coating characterization

All acceptance criteria were met.

Results concluded that the TREGOR® Dual Mobility Acetabular System finished product and its components met all pre-determined specifications and are adequate for their intended use.

Clinical data were not required for this device.

K11981 TREGOR® Dual Mobility Acetabular System Section 5

K111981 - Supplement #2 TREGOR® Dual Mobility Acetabular System Appendix 2 - Page 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Aston Medical % Gloster Biomedical International Ms. Catherine Gloster, M.Sc., RAC Regulatory Consultant 577 North Hope Avenue Santa Barbara, California 93110

Received: September 24, 2012

OCT 12 2012

Re: K11981

Trade/Device Name: TREGOR® Dual Mobility Acetabular System 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, LPH, JDI Dated: September 21, 2012

Dear Ms. Gloster:

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

{5}------------------------------------------------

Page 2 - Ms. Catherine Gloster, M.Sc., RAC

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/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

. Sincerely yours,

for R

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indication for Use

510(k) K111981 .

TREGOR® Dual Mobility Acetabular System manufactured by Aston® Medical.

Indications for Use:

The TREGOR® Dual Mobility Acetabular System is indicated for hip pathologies requiring total hip replacement (THR):

. Non inflammatory or rheumatoid arthritis;
. Osteonecrosis of femoral head;
. Hip deformity affecting its function;
Non-union head fracture or complex pertrochanteric fracture that are . unmanageable using other techniques;
. Revision of previous hip surgery;
Dislocation risks (e.g., ASA score ≥ 3) .

The TREGOR® Dual Mobility Acetabular System hip prosthesis is intended for use in skeletally mature individuals undergoing surgery for rehabilitating hip joints.

Method of fixation:

When used with the TREGOR® Standard acetabular cup with dual Ti/HA coating, the TREGOR® Dual Mobility Acetabular System is for cementless use only and press fit application.

When used with the TREGOR® Medial Cup acetabular cup, the TREGOR® Dual Mobility Acetabular System is for cemented use only. An optional acetabular

Section 4

Appendix 1 - Page 1

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111981

Prescription Use _X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

ASL

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

KIII 98 510(k) Number .

K111981 - Supplement #2 TREGOR® Dual Mobility Acetabular System Appendix 1 - Page 2

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.