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; 1)
1. Rheumatoid arthritis:
1. Correction of functional deformity;
1. 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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Restoration® ADM System X3® Acetabular Insert, based on the provided text:

Summary of Device Acceptance Criteria and Performance

Acceptance Criteria Category	Specific Test/Measure	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical/Material	Material Properties Characterization	Equivalence to predicate devices	Performed and demonstrated "equivalence of the subject products to the predicate devices."
Mechanical/Wear	Hip Simulated Wear Testing	Equivalence to predicate devices	Performed and demonstrated "equivalence of the subject products to the predicate devices."
Mechanical/Assembly	Disassembly Force Evaluation	Equivalence to predicate devices	Performed and demonstrated "equivalence of the subject products to the predicate devices."
Risk Management	Risk Analysis	Acceptable risk profile compared to predicate	Performed and demonstrated "equivalence of the subject products to the predicate devices."

Study Information

Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The study involved in-vitro testing (material properties, wear, disassembly force), not human clinical data. Therefore, "data provenance" in terms of country of origin or retrospective/prospective does not apply to this type of testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device is based on engineering and material science standards and measurements, not expert human interpretation of medical images or conditions. The "ground truth" is derived from the physical testing results and comparison to predicate device performance.
Adjudication method for the test set: Not applicable. As the "ground truth" is derived from physical and mechanical testing, there is no human adjudication process involved.
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 is a physical orthopedic implant, not an AI/software device that involves human reader interpretation. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical orthopedic implant, not an algorithm or AI.
The type of ground truth used: The ground truth for this device's performance is based on engineering test standards and the performance of legally marketed predicate devices. The text states, "A risk analysis and research and development testing have been performed to demonstrate equivalence of the subject products to the predicate devices."
The sample size for the training set: Not applicable. This is a physical orthopedic implant, not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable. As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment in that context.

Summary

{0}------------------------------------------------

K093644

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 ornonporous uncemented prosthesis, 21 CFR §888.3353
Proposed Regulatory Class:	Class II
Product Codes:	87 MEH, 87 LZO
For Information contact:	Avital Merl-MarguliesRegulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365 Fax: (201) 831-3365
Date Prepared:	November 18, 2009

Description:

Intended Use:

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)
1. Rheumatoid arthritis:
1. Correction of functional deformity;
1. 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:

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:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
1. Rheumatoid arthritis
1. Correction of functional deformity;
1. 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

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.