· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 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.

When used with MDM Liners
· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
· Dislocation risks

When used with Constrained Liner:
· The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration® Anatomic Shell is indicated for cementless use only.

Device Description

The Restoration Anatomic Shell is a sterile, single-use device that is intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The subject device substrate is manufactured from Ti-6Al-4V ELI alloy and has a porous CP-Ti coating. The materials, design features and screw hole locations of the Restoration Anatomic Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device and therefore describes a device that is substantially equivalent to a predicate device. Information regarding acceptance criteria and detailed study results as requested in the prompt are generally not included in 510(k) summaries to the same extent as they would be for a PMA application or a clinical trial publication.

Based on the provided text, the device is the Restoration Anatomic Shell, which is a hip joint prosthesis component. The submission is for adding compatibility with Trident Polyethylene Liners and clarifying indications for use.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the form of numerical thresholds or performance targets for a device that uses AI/algorithm. Instead, it refers to non-clinical testing performed to establish substantial equivalence to predicate devices. This type of regulatory submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The non-clinical tests performed are:

Test Type	Reported Device Performance
Lever-out Test of a Trident Polyethylene Liner in a Trident Shell	Not detailed in the provided text, presumably met internal criteria for substantial equivalence.
Push-out Test of a Trident Polyethylene Liner in a Trident Shell	Not detailed in the provided text, presumably met internal criteria for substantial equivalence.
Lever-out Test of a Trident Constrained Polyethylene Liner in a Trident Shell	Not detailed in the provided text, presumably met internal criteria for substantial equivalence.
Range of Motion for the Trident 0° Constrained Acetabular Liner	Not detailed in the provided text, presumably met internal criteria for substantial equivalence.

Important Note: This document does not describe the acceptance criteria or performance of an AI/algorithm-based device. It pertains to a physical medical device (a hip prosthesis component).

Regarding AI/Algorithm-specific questions (which are not applicable to this document):

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device, not an AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

Study Type: Non-clinical laboratory testing.
Clinical Testing: The document explicitly states: "Clinical testing was not required as a basis for substantial equivalence." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.
Basis for Equivalence: The submission claims substantial equivalence to predicate devices (Restoration Anatomic Shell K142462 and Trident Porous Titanium Acetabular Shell K010170) in terms of intended use, indications, design, materials, performance characteristics, and operational principles.
Device Description: The device is a sterile, single-use, cementless acetabular shell made from Ti-6Al-4V ELI alloy with a porous CP-Ti coating. Its design features and screw hole locations are identical to its primary predicate. The submission focuses on adding compatibility with different liners.

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 features the department's name arranged in a circular fashion around a symbol. The symbol consists of a stylized caduceus with three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth.

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

August 10, 2015

Stryker Orthopaedics Ms. Allison Ling Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K151264 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: July 8, 2015 Received: July 10, 2015

Dear Ms. Ling:

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 (reporting of medical device

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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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Mark N. Melkerson -S

Mark 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)

Unknown K151264 (page 1 / 1)

Device Name

Restoration Anatomic Shell

Indications for Use (Describe)

· Painful, disabling joint disease of the hip from: degenerative arthritis, theumatoid 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 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.

When used with MDM Liners

· Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

· Dislocation risks

When used with Constrained Liner:

· The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

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

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Sponsor	Stryker Orthopaedics325 Corporate DriveMahwah, NJ 07430
Contact Person	Allison M. LingRegulatory Affairs SpecialistStryker Orthopaedics325 Corporate DriveMahwah, NJ 07430P: (201) 831 6520F: (201) 831 3520
Alternate Contact:	Patricia Sett-LaPerchManager, Regulatory AffairsHowmedica Osteonics Corp325 Corporate DriveMahwah, NJ 07430P: 201 831 5938F: 201 831 4938
Date Prepared:	May 12th, 2015
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:

Primary: Restoration Anatomic Shell (K142462) ●
. Secondary: Trident Porous Titanium Acetabular Shell (K010170)

Device Description:

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Shell are identical to the primary predicate device cleared in K142462. The purpose of this submission is to add compatibility of Trident Polyethylene Liners and clarify the indications for use for specific compatible liners.

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.

When used with MDM Liners

Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Dislocation risks 0

When used with Constrained Liner:

The Trident Constrained Acetabular Insert is indicated for use in primary and revision o patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.
The Restoration Anatomic Shell is indicated for cementless use only.

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.

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Non-Clinical Testing: The following non-clinical laboratory testing has been provided to determine substantial equivalence:

1. Lever-out Test of a Trident Polyethylene Liner in a Trident Shell
1. Push-out Test of a Trident Polyethylene Liner in a Trident Shell
1. Lever-out Test of a Trident Constrained Polyethylene Liner in a Trident Shell
1. Range of Motion for the Trident 0° Constrained Acetabular Liner

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.