The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

· Osteoarthritis
· Post-traumatic arthrosis
Focal avascular necrosis of the humeral head
· Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
· Rheumatoid arthritis.
· Revision where other devices or treatments have failed.
· Correction of functional deformity.
· Fractures of the humeral head (with Short Humeral Stems)
· Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
· Difficult clinical management problems where other methods of treatment may not be inadequate.

Fixation Methods

The humeral stems are intended for cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder

The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

· A severely painful, disabling, arthritic joint
· Fractures of the humeral head (with Short Humeral Stems)
· Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
· Revisions of previously failed shoulder joint replacements

Fixation Methods

The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Device Description

The INHANCE™SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), peripheral posts (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the INHANCE™ Shoulder System - Humeral Stems and Stemless Anchors. This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

The information primarily focuses on the non-clinical testing performed to support this claim of substantial equivalence, as clinical testing was not deemed necessary. Therefore, the request for details related to human reader studies, expert ground truth, and training data applies to the scenario of AI/ML device testing, which is not the case here.

However, based on the provided text, we can describe the acceptance criteria and the study that proves the device meets them, primarily from a non-clinical/engineering perspective.

Here's the breakdown of the acceptance criteria and study as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Construct Fatigue Testing (based on ASTM F1378 methods)	"The acceptance criteria were met, demonstrating substantial equivalence of the subject and predicate devices." (Implies the subject device performed comparably or better than the predicate devices under fatigue testing, meeting the established thresholds for the predicate).
Range of Motion (RoM) Evaluation	"The subject devices do not represent a new worst-case for range of motion when compared to the predicate devices." (Implies RoM performance is not worse than the predicate).
Construct Loosening and Disassociation	"The subject devices do not represent a new worst-case for construct loosening and disassociation when compared to the predicate devices." (Implies loosening and disassociation performance is not worse than the predicate).
Biocompatibility Assessments	"The subject devices do not represent a new worst-case for biocompatibility when compared to the predicate devices." (Implies biocompatibility is not worse than the predicate).
Porous Structure Characterization	"Further characterization was not required" as the porous structure is "identical" to predicate devices. (Implies the porous structure meets the same criteria as the predicate).
MRI Compatibility	"The subject devices do not represent a new worst-case for MRI compatibility when compared to the predicate devices." (Implies MRI compatibility is not worse than the predicate).
Shelf Life Evaluation	"The subject devices do not represent a new worst-case for shelf life when compared to the predicate devices." (Implies shelf life is not worse than the predicate).
Sterilization Validation	"The subject devices do not represent a new worst-case for sterility when compared to the predicate devices." (Implies sterility is not worse than the predicate).

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

Sample Size: The document does not specify the exact number of units or samples used for each non-clinical test (e.g., how many humeral stems were subjected to fatigue testing). It generally refers to "the subject devices" without providing specific counts.
Data Provenance: Not applicable in the context of non-clinical device testing with patient data. The testing is performed on physical devices in a controlled laboratory environment. The testing methods are "well-established methods" and "per the methods described in ASTM F1378."

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

This is not applicable as the evaluations are non-clinical (mechanical, material, dimensional, etc.) and do not involve human judgment or interpretation of medical images or patient data. Ground truth is established by engineering standards (e.g., ASTM F1378) and physical measurements.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on objective, quantifiable engineering tests and comparisons to predicate device performance, not on subjective human interpretation or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Shoulder System Humeral Stems and Stemless Anchors to the predicate devices." Such studies are typically for AI/ML devices assisting human readers with diagnostic tasks.

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

No, a "standalone" performance study in the context of an algorithm or AI was not done. The device is a physical shoulder implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by engineering standards, validated test methods (e.g., ASTM F1378), and direct comparison to the performance of the legally marketed predicate devices. The goal is to show that the new device's performance is not worse than the predicate.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as above.

Summary

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December 2, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Depuy Ireland UC % Russ Parrott VP of Research and Development Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, Indiana 46590

Re: K223211

Trade/Device Name: INHANCETM Shoulder System - Humeral Stems and Stemless Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, MBF, KWT, KWS, PKC, PAO, HSD Dated: October 14, 2022 Received: October 17, 2022

Dear Russ Parrott:

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 ffor 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/cfpm/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

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requirements, including, but not limited to: registration and listing (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,

Image /page/1/Picture/5 description: The image shows the name "Victoria A. Lilling -S" in a large, clear font. The text is positioned on the left side of the image. The background is a light blue color, with a watermark-like design in the background.

Digitally signed by Victoria A. Lilling -S Date: 2022.12.02 15:24:38 -05'00'

Victoria Lilling, M.D. 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

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Indications for Use

510(k) Number (if known)

K223211

Device Name

INHANCE™ Shoulder System - Humeral Stems and Stemless Anchors

Indications for Use (Describe)

Anatomic Total Shoulder or Hemi-Shoulder

The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

· Osteoarthritis
· Post-traumatic arthrosis
Focal avascular necrosis of the humeral head
· Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
· Rheumatoid arthritis.
· Revision where other devices or treatments have failed.
· Correction of functional deformity.
· Fractures of the humeral head (with Short Humeral Stems)
· Fractures of the humeral head and proximal humerus, where other methods of treatment

are deemed inadequate (with Standard or Long Stems)

· Difficult clinical management problems where other methods of treatment may not be inadequate.

Fixation Methods

The humeral stems are intended for cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder

· A severely painful, disabling, arthritic joint
· Fractures of the humeral head (with Short Humeral Stems)
· Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
· Revisions of previously failed shoulder joint replacements

Fixation Methods

The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

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Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image contains the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left, followed by the word "IGNITE" in gray, sans-serif font. Below "IGNITE" is the word "ORTHOPEDICS" in a smaller, sans-serif font, also in gray.

510(k) Summary Prepared: October 14, 2022 Submitter: Ignite Orthopedics LLC 700 Park Ave. Suite F Winona Lake, IN 46590 Russ Parrott Contact: Chief Technology Officer Phone: 574.527.2864 russ.parrott@igniteorthopedics.com INHANCETM Shoulder System - Humeral Stems and Stemless Proprietary Name: Anchors Common Name: Anatomic and Reverse Shoulder Arthroplasty System Classification: Shoulder joint metal/polymer semi-constrained cemented prosthesis; (21 CFR §888.3660); Class II Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-Porous Coated, Uncemented Prosthesis Constrained. CFR (21 $888.3670); Class II Prosthesis, Shoulder, Non-Constrained, Metal/Polymer, Cemented (21 CFR §888.3650); Class II Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Cemented (21 CFR $888.3660); Class II Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, (21 CFR $888.3690); Class II Total Anatomic Shoulder, Uncemented Metaphyseal Prosthesis. Humeral Stem With No Diaphyseal Incursion, Semi-Constrained (21 CFR §888.3660); Class II Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (21 CFR §888.3660); Class II

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	Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis(21 CFR §888.3690); Class II
Product Codes:	PHX, MBF, KWT, KWS, PKC, PAO, HSD
Predicate Device:	K212737 – (Primary) INHANCE Reverse Shoulder System, DePuyIreland UC
	K202716 – INHANCE Anatomic Shoulder System; DePuy Ireland UC(formerly Ignite Anatomic Shoulder System; Ignite Orthopedics LLC)
	K203108 – INHANCE Stemless Anatomic Shoulder System; DePuyIreland UC (formerly Ignite Stemless Anatomic Shoulder System; IgniteOrthopedics LLC)

Device Description:

The INHANCE™SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

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Image /page/6/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic, the word "IGNITE" is written in a gray sans-serif font, and below that, the word "ORTHOPEDICS" is written in a smaller, similar font.

Intended Use / Indications for Use:

Anatomic Total Shoulder or Hemi-Shoulder

The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

· Osteoarthritis
Post-traumatic arthrosis
· Focal avascular necrosis of the humeral head
Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis.
Rheumatoid arthritis.
· Revision where other devices or treatments have failed.
· Correction of functional deformity.
· Fractures of the humeral head (with Short Humeral Stems)
Fractures of the humeral head and proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)

· Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods

The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder

The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral

stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

· A severely painful, disabling, arthritic joint
· Fractures of the humeral head (with Short Humeral Stems)
· Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
· Revisions of previously failed shoulder joint replacements

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Fixation Methods

The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Summary of Technologies/Substantial Equivalence:

The subject INHANCE Shoulder System - Humeral Stems and Stemless Anchors has the same indications for use intended use, material, manufacturing method, sterilization, and packaging as the previously cleared devices in the INHANCE Anatomic Shoulder System (K202716), the INHANCE Stemless Anatomic Shoulder System (K203108), and the INHANCE Reverse Shoulder System (K212737).

The difference between the subject and predicate device is in the printing orientation and layer thickness in the additive manufacturing process of the stemmed humeral anchors. The finished form (geometry and biocompatibility) of the device is unaffected. Modifications to the additive manufacturing process do not result in greater risks of device fracture/failure. Because of these similarities, the subject of this submission, the INHANCE Shoulder System - Humeral Stems and Stemless Anchors, is substantially equivalent to the predicate INHANCE Anatomic Shoulder System (K202716), INHANCE Stemless Anatomic Shoulder System (K203108), and INHANCE Reverse Shoulder System (K212737).

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Image /page/8/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic is the word "IGNITE" in a gray sans-serif font, with the word "ORTHOPEDICS" in a smaller font below it.

Non-Clinical Testing:

The INHANCE™ Shoulder System Humeral Stems and Stemless Anchors were evaluated using well-established methods to demonstrate substantial equivalence to the predicate devices.

The following evaluations were completed:

Construct Fatigue Testing

Construct fatigue testing was performed on the subject devices per the methods described in ASTM F1378. The test methods and acceptance criteria were the same as utilized for the predicate devices. The acceptance criteria were met, demonstrating substantial equivalence of the subject and predicate devices.

Range of Motion (RoM) Evaluation

The geometry of the subject and predicate devices are identical. Therefore, the subject devices do not represent a new worst-case for range of motion when compared to the predicate devices.

Construct Loosening and Disassociation

The geometry of the subject and predicate devices are identical. Therefore, the subject devices do not represent a new worst-case for construct loosening and disassociation when compared to the predicate devices.

Biocompatibility Assessments

The raw materials and contact materials used in the manufacture of the subject Humeral Stems and Stemless Anchors are identical to those used on implants cleared in the predicate device submissions. Therefore, the subject devices do not represent a new worst-case for biocompatibility when compared to the predicate devices.

Porous Structure Characterization

The porous structure used for the subject device is identical to the porous structure that was applied to the predicate devices. Therefore, further characterization was not required.

MRI Compatibility

The geometry and magnetism of the materials of the subject and predicate devices are identical. Therefore, the subject devices do not represent a new worst-case for MRI compatibility when compared to the predicate devices.

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Image /page/9/Picture/0 description: The image shows the logo for Ignite Orthopedics. The logo features a blue flame-like graphic on the left side. To the right of the graphic, the word "IGNITE" is written in a gray, sans-serif font, and below that, the word "ORTHOPEDICS" is written in a smaller, sans-serif font.

Shelf Life Evaluation

The subject devices use the same material and sterile packaging as the predicate devices. Therefore, the subject devices do not represent a new worst-case for shelf life when compared to the predicate devices.

Sterilization Validation

The subject devices use the same material, manufacturing locations, and sterile packaging as the predicate devices. Therefore, the subject devices do not represent a new worst-case for sterility when compared to the predicate devices.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Shoulder System Humeral Stems and Stemless Anchors to the predicate devices.

Conclusion:

A comparison of the subject and predicate devices, including comparison of the intended use, technological characteristics, and non-clinical evaluations has demonstrated that the subject devices have a safety and effectiveness profile equivalent to that of the predicate devices.

Regulation Number and Section

N/A

Indications for Use

510(k) Number (if known)

Fixation Methods

Reverse Total Shoulder

Fixation Methods

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Device Description:

Intended Use / Indications for Use:

Anatomic Total Shoulder or Hemi-Shoulder

Fixation Methods

Reverse Total Shoulder

The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral

Fixation Methods

Summary of Technologies/Substantial Equivalence:

Non-Clinical Testing:

Construct Fatigue Testing

Range of Motion (RoM) Evaluation

Construct Loosening and Disassociation

Biocompatibility Assessments

Porous Structure Characterization

MRI Compatibility

Shelf Life Evaluation

Sterilization Validation

Clinical Testing:

Conclusion:

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