Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.

The Restoration® Anatomic Shell is indicated for cementless use only.

Device Description

The Restoration Anatomic Shell is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The basic design of the Restoration Anatomic Shell is similar to two other commercially available total hip systems, which are Stryker Orthopaedics' Trident Porous Titanium Acetabular Shell, and DePuy's S-ROM Oblong Cup. The Restoration Anatomic Shell will be available in 14 sizes, 54mm - 80mm diameter in 2mm increments. There will be a left and right shell configuration for each size. The subject device is designed to accept the existing Modular Dual Mobility (MDM) liners. The locking mechanism is identical to the locking mechanism of the predicate Trident Porous Titanium Acetabular Shell. The implant will be made of Ti-6Al-4V ELI alloy (ASTM F136) and will have a porous Commercially Pure (CP)-Ti (ASTM F1580) coating allowing for biological fixation. The inner locking mechanism is positioned eccentrically relative to the outer surface of the shell, thus creating a build-up of solid material intended to be positioned in the superior region of the acetabulum. The area outside the locking mechanism will have a recessed or beveled surface to reduce the amount of implant that is exposed outside of the native acetabulum. The shell will have multiple screw hole options located in the superior and inferior regions of the shell as well as peripheral screw holes located outside the locking mechanism. The Restoration Anatomic Shell is compatible with the optional currently marketed Stryker Orthopaedics Acetabular Dome Hole Plug made from CP Titanium (ASTM F-67).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Restoration Anatomic Shell" hip replacement device:

It is important to note that this document is a 510(k) Premarket Notification for a medical device. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to independently prove the device's efficacy and safety through extensive clinical trials. Therefore, the information provided will reflect this type of regulatory submission, which often relies heavily on non-clinical (bench) testing and comparison to established predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format, as one might expect for a software or diagnostic device. Instead, the "acceptance criteria" are implied by the performance characteristics demonstrated through the non-clinical tests, and by the claim of substantial equivalence to predicate devices. The "reported device performance" is largely framed within the context of these non-clinical tests.

Acceptance Criteria (Implied)	Reported Device Performance (Summary from Non-Clinical Testing)
Mechanical Stability/Retention of Liner: Ability to securely hold the Modular Dual Mobility (MDM) liner, even under deformation. (Implied: comparable to predicate or acceptable industry standards)	Push-out Test of a Modular Dual Mobility Liner in a Deformed Shell: Performed to assess the securement of the MDM liner. While specific results are not provided, the claim of substantial equivalence implies acceptable performance. This test would likely evaluate the force required to dislodge the liner, ensuring it remains in place during normal physiological loading and potential stress scenarios.
Fatigue Resistance/Durability: Ability to withstand cyclical loading over the expected lifespan of the implant, especially for augmented components. (Implied: comparable to predicate or acceptable industry standards)	Acetabular Wedge Augment Device Fatigue Model: Performed to assess the long-term durability of any augmented components. Again, specific results are not detailed, but the test's inclusion and the claim of substantial equivalence suggest that the device's fatigue life is considered adequate and comparable to predicate devices.
Biomaterial Properties (Coating): Adhesion, porosity, and microstructure of the porous coating for biological fixation. (Implied: meets specified ASTM standards and is comparable to predicate for encouraging bone ingrowth)	Mechanical Properties of the Tritanium Foam Coating: Evaluated the mechanical characteristics of the coating material (CP-Ti). Material Microstructure, Composition, and Trace Elemental Analysis of the Substrate and Surface of the Tritanium Acetabular Shells: Confirmed the material properties (Ti-6Al-4V ELI alloy for substrate, porous CP-Ti for coating) and composition, ensuring it meets specified ASTM standards (ASTM F136, ASTM F1580, ASTM F-67 for optional plug) and is biocompatible. Structural Characteristics of the Tritanium Foam Coating: Assessed the specific architectural features of the porous coating, which are crucial for promoting biological fixation and long-term stability. The claim of substantial equivalence implies these properties are suitable for cementless fixation.
Overall Design and Functional Equivalence: Similar intended use, indications, design, materials, performance characteristics, and operational principles to predicate devices.	Summary of Technological Characteristics: "Device Comparisons show that the Restoration Anatomic Shell is substantially equivalent to its predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles." This is the overarching "stated performance."

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

Since the study relies on non-clinical (bench) testing, the concept of a "test set" in the sense of patient data is not applicable. For non-clinical tests, the "sample size" would refer to the number of physical device units or components tested for each specific test (e.g., how many shells were subjected to push-out, or how many fatigue samples were run). This specific number is not provided in the summary.

Data Provenance: The data is generated from laboratory testing performed by the manufacturer, Stryker Orthopaedics. It is inherently prospective in the sense that the tests were conducted specifically for this submission, using newly manufactured devices or components. The concept of "country of origin of the data" typically relates to clinical studies; for bench testing, it refers to the location of the testing facility, which would likely be in the US given the submitting company's location (Mahwah, NJ) and the FDA submission.

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

This question is not applicable to this 510(k) submission, as no clinical test set relying on expert ground truth was performed. The evaluation is based on engineering and materials science principles and direct comparison to predicate devices, not on human interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was performed.

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. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a mechanical implant device like a hip shell. The submission explicitly states: "Clinical testing was not required as a basis for substantial equivalence."

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

This question is not applicable. The "Restoration Anatomic Shell" is a physical medical device, not a software algorithm or AI. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the non-clinical tests is established by:

Engineering specifications and standards: Adherence to ASTM (American Society for Testing and Materials) standards for materials (e.g., F136, F1580, F-67).
Established mechanical testing protocols: Performance measurements against defined biomechanical limits or within expected ranges identified through established engineering principles and prior device testing.
Comparison to predicate devices: The "ground truth" for substantial equivalence is primarily the performance and characteristics of the legally marketed predicate devices (Trident Porous Titanium Acetabular Shell and S-ROM Oblong Cup). The subject device must perform similarly or better in relevant non-clinical tests to be considered substantially equivalent.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device, as it is a physical implant and not a machine learning model.

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

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

November 14, 2014

Stryker Orthopaedics Ms. Denise Daugert Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K142462 Trade/Device Name: Restoration Anatomic Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: August 29, 2014 Received: September 2, 2014

Dear Ms. Daugert:

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 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

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Page 2 - Ms. Denise Daugert

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Lori A. Wiggins -S

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

Enclosure

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Indications for Use

510(k) Number (if known): K142462

Device Name: Restoration Anatomic Shell

Indications for Use:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques ● as indicated by deficiencies of the acetabulum.

The Restoration® Anatomic Shell is indicated for cementless use only.

Prescription Use(Part 21 CFR 801 Subpart D)	X
-------------------------------------------------	---

AND/OR

Over-The-Counter Use(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

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510(k) Summary

Sponsor	Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Denise DaugertSr. Regulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, NJ 07430P: (201) 831 5413F: (201) 831 4413
Alternate Contact:	Patricia Sett-LaPerchManager, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430P: 201 831 5938F: 201 831 4938
Date Prepared:	August 29, 2014
Proprietary Name:	Restoration Anatomic Shell
Common Name:	Total Hip Joint Replacement
Classification Name:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis. (888.3358)
Product Codes:	LPH

Legally Marketed Device to Which Substantial Equivalence is claimed:

Trident Porous Titanium Acetabular Shell (K010170) ●
. S-ROM Oblong Cup (K905258)

Device Description:

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Cup. The Restoration Anatomic Shell will be available in 14 sizes, 54mm - 80mm diameter in 2mm increments. There will be a left and right shell configuration for each size. The subject device is designed to accept the existing Modular Dual Mobility (MDM) liners. The locking mechanism is identical to the locking mechanism of the predicate Trident Porous Titanium Acetabular Shell. The implant will be made of Ti-6Al-4V ELI alloy (ASTM F136) and will have a porous Commercially Pure (CP)-Ti (ASTM F1580) coating allowing for biological fixation. The inner locking mechanism is positioned eccentrically relative to the outer surface of the shell, thus creating a build-up of solid material intended to be positioned in the superior region of the acetabulum. The area outside the locking mechanism will have a recessed or beveled surface to reduce the amount of implant that is exposed outside of the native acetabulum. The shell will have multiple screw hole options located in the superior and inferior regions of the shell as well as peripheral screw holes located outside the locking mechanism. The Restoration Anatomic Shell is compatible with the optional currently marketed Stryker Orthopaedics Acetabular Dome Hole Plug made from CP Titanium (ASTM F-67).

Intended Use: The Restoration Anatomic Shell is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

Indications for Use:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive techniques . as indicated by deficiencies of the acetabulum.

The Restoration Anatomic Shell is indicated for cementless use only.

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Summary of Technological Characteristics: Device Comparisons show that the Restoration Anatomic Shell is substantially equivalent to its predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.

Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:

1. Push-out Test of a Modular Dual Mobility Liner in a Deformed Shell
1. Acetabular Wedge Augment Device Fatigue Model
1. Mechanical Properties of the Tritanium Foam Coating
1. Material Microstructure, Composition, and Trace Elemental Analysis of the Substrate and Surface of the Tritanium Acetabular Shells
1. Structural Characteristics of the Tritanium Foam Coating

Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.

Conclusion: The Restoration Anatomic Shell is substantially equivalent to the predicate devices identified in this premarket notification.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.