· 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 subject Restoration Anatomic Shell are identical to the predicate device cleared via premarket notifications K153345, K151264, and K142462.

AI/ML Overview

The provided text is a 510(k) summary for the Restoration Anatomic Shell, a hip joint prosthesis. It does not describe any acceptance criteria or a study that proves the device meets those criteria from a performance or clinical standpoint.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, with the only changes being to the packaging configuration.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is not present in the provided text.

Here's a breakdown of what the document does say regarding testing, which relates to the packaging change:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document mentions that packaging configuration changes necessitated specific testing. The criteria for these tests would be defined within the referenced standards.
Reported Device Performance: The document states that a "ship test study was completed on the subject device to qualify the proposed packaging configuration." It also mentions "Product bioburden and cytotoxicity testing were executed as the proposed packaging configuration constitutes a change in packaging materials that contact the product after final cleaning."
- Packaging Performance: "Testing was completed per ISO 11607-1, ASTM F1886, ASTM D4169, ASTM F2825, ASTM F88/F88M, and ASTM F2096, and ASTM F2097." The outcome is implicitly positive, as the device received 510(k) clearance, suggesting the packaging met the requirements of these standards.
- Bioburden Performance: "Bioburden testing was completed per ISO 11737-1."
- Cytotoxicity Performance: "Cytotoxicity testing was completed per ISO 10993-5."
- Results: The conclusion that "The proposed modifications do not affect safety or effectiveness" implies these tests were passed, but specific performance metrics are not detailed in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document as it did not involve clinical or performance studies for the device itself, only packaging validation.

3. 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)

This information is not applicable as there was no test set requiring expert ground truth establishment for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there was no test set requiring adjudication for clinical performance.

5. 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

This information is not applicable as this is a hip joint prosthesis, not an AI-assisted diagnostic device, and no MRMC study was conducted or required.

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

This information is not applicable as this is a hip joint prosthesis, not an algorithmic diagnostic device, and no standalone performance study was conducted or required.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable as there was no clinical performance study for the device described. The "ground truth" for the packaging validation would be the physical and biological integrity after testing, as per the specified ISO and ASTM standards.

8. The sample size for the training set

This information is not applicable as no training set was involved (no AI or analytical model development for device performance was described).

9. How the ground truth for the training set was established

This information is not applicable for the reasons mentioned above.

Summary

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April 22, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Howmedica Osteonics Corp. a.k.a. Stryker Orthopaedics Alexandra Kirby Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K210893

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: March 24, 2021 Received: March 25, 2021

Dear Alexandra Kirby:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K210893

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Name and Address of Sponsor	Stryker Orthopaedics
and Manufacturing Site	325 Corporate Drive
	Mahwah, NJ 07430

Contact Person:	Alexandra Kirby
	Regulatory Affairs Specialist
	Stryker Orthopaedics
	325 Corporate Drive
	Mahwah, New Jersey 07430
	(201) 831-5963

Alternate Contact:	Paula McCarthy
	Senior Manager, Regulatory Affairs & Labelling
	Stryker Orthopaedics
	Raheen Business Park
	Limerick
	Ireland
	V94 X6T4
	+353 (0)87 2824403

Date Prepared:	March 24, 2021

Proprietary Name:	Restoration Anatomic Shell

Common Name:	Total Hip Joint Replacement

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Classification Name and Reference: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR క్రి88.3358)

Product Codes:

LPH

Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed:

. Restoration Anatomic Shell (K153345)

Legally Marketed Reference Device Used to Support Substantial Equivalence:

. Restoration Acetabular Wedge Augment (K153345, K102019)
Restoration Anatomic Shell (K151264, K142462)

Device Description

Intended Use

There is no change to the intended use for the subject device.

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.

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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 .

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.

Summary of Technological Characteristics

The subject device is identical in intended use, indications for use, product design, product materials, and operational principles as the predicate device. The subject device is different from the predicate device in terms of the packaging configuration. The current packaging configuration features a double layer of packaging; the outer packaging layer is the sterile barrier, and the inner packaging layer is a protective layer. The proposed packaging configuration features an inner packaging layer that is Surlyn sealed to Tyvek lidding which is then placed into an outer sterile barrier layer consisting of pre-form rigid blister tray sealed to Tyvek lidding.

Non-Clinical Testing

There is no change to the device design or device materials. Non-clinical testing was not required as a basis for substantial equivalence.

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A ship test study was completed on the subject device to qualify the proposed packaging configuration. Testing was completed per ISO 11607-1, ASTM F1886, ASTM D4169, ASTM F2825, ASTM F88/F88M, ASTM F2096, and ASTM F2097.

Product bioburden and cytotoxicity testing were executed as the proposed packaging configuration constitutes a change in packaging materials that contact the product after final cleaning. Bioburden testing was completed per ISO 11737-1 and cytotoxicity testing was completed per ISO 10993-5.

Clinical Testing

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

Conclusion

The subject Restoration Anatomic Shell is substantially equivalent in intended use, indications for use, product design, product materials, and operational principles to the predicate device. The proposed modifications do not affect safety or effectiveness.

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.