· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement

The iNSitu Total Hip System femoral stem is intended for cementless fixation. The iNSitu Total Hip System acetabular cup is intended for cementless fixation. The porous structured surfaces provide biological fixation in a cementless application.

Device Description

The NextStep Arthropedix Total Hip Replacement System includes a family of femoral stems, femoral head components, acetabular UHMWPE liners, acetabular cups (including solid, 3-holed, and the subject multiholed), acetabular hole covers, optional acetabular screws, instruments, and sterilization cases (K161184/K172501). The implants are packaged in single use, sterile packages with a 5-year shelf life and the re-usable instruments are contained in sterilization cases for steam sterilization.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the iNSitu Total Hip System:

The provided text is a 510(k) summary for a medical device (iNSitu Total Hip System) that is seeking clearance as substantially equivalent to existing devices. In this context, "acceptance criteria" and "study" are interpreted in terms of demonstrating substantial equivalence, rather than directly measuring performance against predefined clinical metrics like sensitivity or specificity for a diagnostic algorithm.

Specifically, this submission is to add a multi-holed acetabular cup to an already cleared total hip system. Therefore, the "acceptance criteria" revolve around showing that the new component does not raise new questions of safety or effectiveness and performs comparably to the previously cleared predicate device.

Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
| Intended Use Equivalence | The new multi-holed acetabular cup must have the same indications for use as the predicate device. | "The iNSitu Total Hip System multi-holed acetabular cup has the indications for use as the iNSitu Total Hip System acetabular cup predicate device." This explicitly states that the intended use is the same. |
| Technological Characteristics Equivalence | The materials, manufacturing processes, and design features of the new multi-holed component must be comparable to the predicate, with consideration given to the impact of the added holes. Changes should not introduce new safety concerns. | "The multi-holed acetabular cups are manufactured from the same materials and processes as the family of acetabular cups in the original iNSitu Total Hip System (K161184/K172501). All iNSitu Total Hip System components...are cleaned, packaged and sterilized using the same processes as previously described..." "The subject multi-holed acetabular cup is equivalent to the original acetabular cup based on comparisons of intended use, design features, and technological characteristics." |
| Performance (Mechanical) Equivalence | The mechanical performance of the multi-holed acetabular cup, particularly regarding fatigue strength, must be demonstrated to be equivalent or superior to the predicate, especially considering the new holes for fixation. | "2-point fatigue testing was performed on the multi-holed acetabular cup to show substantial equivalence to the predicate device." (It explicitly states the test was performed to show substantial equivalence). |
| Sterilization Equivalence | The sterilization process must effectively sterilize the new component, and the introduction of the multi-holed design should not create a new worst-case scenario that invalidates the existing sterilization validation for the system. | "Risk based EO sterilization was performed to document that the newly introduced iNSitu Multi-Holed Acetabular Cup did not present a new worst-case scenario, and therefore included into the documentation for the existing sterilization process for the predicate device (K161184/K172501)." |
| Overall Substantial Equivalence (Conclusion) | The cumulative evidence from intended use, technological characteristics, and performance testing must demonstrate that the device is substantially equivalent to legally marketed predicate devices and does not raise new questions of safety or effectiveness. | "A comparison of technological characteristics and performance testing demonstrates that the NextStep Arthropedix iNSitu Total Hip System multi-holed acetabular cup is substantially equivalent to the predicate system (K161184/K172501)." |

Study Details (for demonstrating Substantial Equivalence of a Physical Device)

It's crucial to understand that the "study" described here is for a physical orthopedic implant, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions for AI/SaMD (like "number of experts," "adjudication," "MRMC," "ground truth type," "training set size") are not applicable in this context. The "study" involves engineering and biocompatibility testing of the material and design.

Here's an analysis based on the provided text, recognizing the nature of the device:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the "2-point fatigue testing" or "Risk based EO sterilization." For physical device testing, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., a certain number of units or specimens). The text implies sufficient samples were tested to demonstrate substantial equivalence, but the exact number isn't stated.
- Data Provenance: Not explicitly stated, but typically these tests would be performed in a controlled laboratory environment by the manufacturer or a third-party testing facility. The data is prospective in the sense that the tests were specifically conducted for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical implant, "ground truth" is established through engineering and material science standards (e.g., ISO, ASTM) and physical measurements. There isn't a "ground truth expert" in the same way there would be for image interpretation. The "ground truth" is the established mechanical properties required for the device or established sterility assurance levels.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods are relevant for subjective interpretations (like medical image reading). For physical device testing, results are typically quantitative measurements against predefined pass/fail criteria from engineering standards.
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-assisted diagnostic or therapeutic device. No human-in-the-loop performance or reader studies were conducted or are relevant for this type of device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical orthopedic implant. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Measurements. The "ground truth" for the performance tests (fatigue, sterilization) would be derived from:
  - Mechanical Properties: Compliance with established ISO/ASTM standards for orthopedic implants (e.g., fatigue limits for hip components).
  - Sterilization: Achievement of a specified Sterility Assurance Level (SAL) (e.g., 10^-6) as per ISO 11135 for EO sterilization.
  - Biocompatibility: Adherence to ISO 10993 for material safety. (Though not explicitly detailed as a test in this summary, it would have been part of the initial K161184/K172501 clearance).
The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning model. There is no "training set."
How the ground truth for the training set was established:
- Not Applicable. As there is no training set, this question is not relevant.

In summary: K191936 is a 510(k) submission for a change to an existing physical medical device. The "acceptance criteria" discussed are largely met by demonstrating (through materials characterization, design comparison, and specific engineering tests like fatigue and sterilization validation) that the new component is as safe and effective as the previously cleared predicate device. The framework for evaluating AI/SaMD does not directly apply here.

Summary

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

August 20, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle and a human figure. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text to the right of the square.

Theken Companies, LLC % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint-Louis Notre-Dame-De-I'lle-Perrot, Quebec, J7V 7P2, Canada

Re: K191936

Trade/Device Name: iNSitu Total Hip System 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, OQG, LZO, OQI Dated: July 17, 2019 Received: July 19, 2019

Dear Dr. Poggie:

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

{1}------------------------------------------------

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) 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 (OS) 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 mediation-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 Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K191936

Device Name

iNSitu Total Hip System

Indications for Use (Describe)

The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and or disabled joint from osteoarthritis, theumator arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

The following 510(k) Summary is provided in accordance with 21 CFR 807.92.

510(k) Owner and Registration

Owner's Name:	Theken Companies, LLC
	Subsidiary: NextStep Arthropedix
Address:	1800 Triplett Blvd., Akron, OH 44306
Phone Number:	(330) 733-7600
Fax Number:	(330) 733-7602
Date Summary Prepared:	August 9, 2019
Establishment Registration Number:	3002498892

510(k) Contact

Contact:	BioVera, Inc.
Address:	Notre-Dame-de-L'lle-Perrot (QC) J7V 7P2, CA
Phone Number:	514-901-0796
Fax Number:	514-901-0796
Contact Person:	Robert A Poggie, PhD

Device Name and Classification

Device Trade Name:	iNSitu Total Hip System
Device Common Name:	Total Hip Replacement
Regulation Number and Description:	21 CFR 888.335821 CFR 888.3353
Device Class:	Class II
Product Codes:	LPH, OQGLZO, OQI
Advisory Panel:	87 (Orthopedic)

Legally Marketed Predicate

This Special 510(k) submission is to add a multi-holed acetabular cup to the iNSitu Total Hip System (K161184/K172501). The Primary Predicate Device for this system is K161184.

Company	Device Name	510(k) Number(s)	Clearance Date
Theken	iNSitu Total Hip System	K161184	10/14/2016
Theken	iNSitu Total Hip System	K172501	09/21/2017

{4}------------------------------------------------

Device Description

Indications for Use

The iNSitu Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
Acute traumatic fracture of the femoral head or neck;
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement

Summary of Technological Characteristics

The multi-holed acetabular cups are manufactured from the same materials and processes as the family of acetabular cups in the original iNSitu Total Hip System (K161184/K172501). All iNSitu Total Hip System components, including the subject multi-holed acetabular cup, are cleaned, packaged and sterilized using the same processes as previously described in K161184/K172501. The subject multi-holed acetabular cup is substantially equivalent to the original iNSitu Total Hip System (K161184/K172501) acetabular cup but includes multi-holed options for fixation into the acetabulum. The subject multi-holed acetabular cup is equivalent to the original acetabular cup based on comparisons of intended use, design features, and technological characteristics.

Performance Testing

Performance testing was conducted on the iNSitu Total Hip System multi-holed acetabular cup to evaluate the device and to demonstrate substantial equivalence. The results confirm that the multi-holed acetabular cup components are substantially equivalent to the predicate acetabular cup.

2-point fatigue testing was performed on the multi-holed acetabular cup to show substantial equivalence to the predicate device.
Risk based EO sterilization was performed to document that the newly introduced iNSitu Multi-Holed Acetabular Cup did not present a new worst-case scenario, and therefore included into the documentation for the existing sterilization process for the predicate device (K161184/K172501).

Conclusions

The iNSitu Total Hip System multi-holed acetabular cup has the indications for use as the iNSitu Total Hip System acetabular cup predicate device. A comparison of technological characteristics and performance testing demonstrates that the NextStep Arthropedix iNSitu Total Hip System multi-holed acetabular cup is substantially equivalent to the predicate system (K161184/K172501).

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.