The Ignite Stemless Anatomic Shoulder System is total shoulder arthroplasty system consisting of stemless humeral implants (multiple sizes), offset taper adapter, humeral heads (38 - 57mm diameters), and glenoid components (multiple sizes).

The anatomic stemless humeral construct consists of an additively manufactured Ti-6A1-4V Stemless Humeral Implant, a wrought Cobalt-Chromium Humeral Head, and a wrought Ti-6Al-4V Taper Adapter. The all-poly Anatomic Glenoid consists of a Highly Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene articulation surface. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.

The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

AI/ML Overview

The provided text describes the "Ignite Stemless Anatomic Shoulder System" and its FDA 510(k) clearance. This document pertains to a medical device (shoulder prosthesis) and not an AI/ML powered device. Therefore, many of the requested fields regarding acceptance criteria and study design for AI/ML devices are not applicable.

Here's the information that can be extracted or noted as not applicable based on the provided text:

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

Since this is a physical medical device clearance, the "acceptance criteria" are typically related to mechanical performance, material properties, and biocompatibility rather than AI/ML performance metrics like accuracy, sensitivity, or specificity. The text states that "acceptance criteria were met" for various tests.

Acceptance Criteria (from text)	Reported Device Performance (from text)
Exceeded clinically relevant loading conditions with application of adequate safety factor (Humeral Anchor Loosening - Static Stability)	Acceptance criteria were met.
Exceeded clinically relevant loosening displacement requirements (Humeral Anchor Loosening - Cyclic Loosening Evaluation)	Acceptance criteria were met.
Meet established specifications per ASTM F1378 (Range of Motion (RoM) Evaluation)	RoM targets were met.
Biocompatible per ISO 10993-1 and FDA Guidance Document	Devices were found to be biocompatible.
Strength of the device exceeds that required for the intended use (Construct Fatigue Testing)	Acceptance criteria were met.
Compliance with ASTM F2009 (Taper Disassembly Evaluation)	Acceptance criteria were met.
Compliance with ISO 11607-1 and ISO 11607-2 (Shelf Life Evaluation)	Five year shelf life was established.
Sterility Assurance Level (SAL) of 10^-6 per ISO 11137-1 and ISO 11137-2 (Sterilization Validation)	SAL was found to be 10^-6.

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

Not applicable. The clearance is for a physical medical device, not an AI/ML system. Testing involved mechanical and material evaluations, not data sets for AI/ML.

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)

Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on images) is not relevant to the mechanical and material testing performed for this device.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML output, not for physical device testing.

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

Not applicable. This is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

For a physical device like a shoulder prosthesis, "ground truth" would relate to accepted engineering standards, material properties, and biological responses.

Mechanical Testing: Based on established industry standards (e.g., ASTM F1378, ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, ASTM F1854, ASTM F2009) and "clinically relevant loading conditions."
Biocompatibility: Based on ISO 10993-1 and FDA Guidance.
Sterilization: Based on ISO 11137-1 and ISO 11137-2.
Shelf Life: Based on ISO 11607-1 and ISO 11607-2.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Ignite Orthopedics LLC Russ Parott VP of Research and Development 700 Park Avenue Suite F Winona Lake, Indiana 46590

Re: K203108

Trade/Device Name: Ignite Stemless Anatomic Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC, PAO Dated: June 14, 2021 Received: June 15, 2021

Dear Russ Parott:

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

July 16, 2021

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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 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,

Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality

Enclosure

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Indications for Use

510(k) Number (if known) K203108

Device Name

Ignite Stemless Anatomic Shoulder System

Indications for Use (Describe)

The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following:

· Osteoarthritis;
Posttraumatic arthrosis;
· Focal avascular necrosis of the humeral head;
· Previous surgeries of the shoulder that do not compromise the fixation.

Fixation Methods

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

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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510(k) Summary
Prepared:	June 15, 2021
Submitter:	Ignite Orthopedics LLC700 Park Ave.Suite FWinona Lake, IN 46590
Contact:	Russ ParrottVP of Research and DevelopmentPhone: 574.527.2864russ.parrott@igniteorthopedics.com
Proprietary Name:	Ignite Stemless Anatomic Shoulder System
Common Name:	Shoulder Arthroplasty System
Classification:	Prosthesis, Total Anatomic Shoulder, Uncemented MetaphysealHumeral Stem With No Diaphyseal Incursion, Semi-Constrained (21CER §888.3660); Class IIProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive,Cemented (21 CER §888.3660); Class II
Product Codes:	PKC, PAO
Predicate Devices:	K171858 (Primary), Sidus Stem-Free Shoulder, Zimmer GmbHK202716, Ignite Anatomic Shoulder System, Ignite Orthopedics LLCK143552, Simpliciti Shoulder System, Tornier, Inc.K182516, Comprehensive Nano Stemless Shoulder, BiometManufacturing CorpK183194, Arthrex Eclipse Shoulder Prosthesis SystemK173388, Exactech Equinoxe Stemless Shoulder, Exactech IncK193226, AltiVate Anatomic Canal-Sparing (CS) Shoulder, EncoreMedical, L.PK083439, Synthes Epoca Shoulder Prosthesis System, Synthes (USA)

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Device Description:

The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

Intended Use / Indications:

The Ignite Stemless Anatomic Shoulder Prosthesis is intended for use in total shoulder replacement procedures to address the following:

. Osteoarthritis;
Posttraumatic arthrosis;
Focal avascular necrosis of the humeral head; ●
Previous surgeries of the shoulder that do not compromise the fixation. .

Fixation Methods

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

Summary of Technologies/Substantial Equivalence:

The Ignite Stemless Anatomic Shoulder System is substantially equivalent to the predicate devices in terms to of its intended use and indications, material, design, and sizes. While there are minor differences, the non-clinical testing described in the next section demonstrated safety and effectiveness and substantial equivalence between the subject and predicate devices.

Non-Clinical Testing:

The Ignite Stemless Anatomic Shoulder System underwent non-clinical testing and analyses to support a determination of substantial equivalence. The following were completed:

Predicate Comparison Evaluation

A detailed comparison of key technologies and feature dimensions was made between the subject device and predicate devices. The comparison concluded the subject device key technologies and feature dimensions are substantially equivalent to that of the predicate devices.

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Humeral Anchor Loosening (Implant-To-Bone) – Static Stability

The Ignite Shoulder System Stemless Anchor static stability was evaluated via resistance to axial pull-out, torque-out, and lever-out. The subject devices were found to be substantially equivalent to legally marketed predicate devices, which were tested using the same test method and test equipment. The Ignite Stemless Anchors also exceeded clinically relevant loading conditions with the application of an adequate safety factor and the respective acceptance criteria were met.

Humeral Anchor Loosening (Implant-To-Bone) – Cyclic Loosening Evaluation

The Ignite Shoulder System Stemless Anchor was evaluated for resistance to cyclic loosening. The subject devices were found to be substantially equivalent to legally marketed predicate devices, which were tested using the same test method and test equipment. The Ignite Stemless Anchors also exceeded clinically relevant loosening displacement requirements and the respective acceptance criteria were met.

Range of Motion (RoM) Evaluation

An evaluation was conducted to ensure the RoM of the worst-case subject device components meet established specifications per ASTM F1378. The RoM targets were met.

Biocompatibility Assessments

The contact classification for the subject devices is Implant, Bone/Tissue with permanent contact (>30 days). A Biocompatibility Assessments was completed and provided per ISO 10993-1 and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The devices were found to be biocompatible.

Porous Structure Characterization

The porous structure used for the subject device was fully characterized. The following data were provided:

Shear Strength per ASTM F1044
Tensile Strength per ASTM F1147 ●
Shear Fatigue per ASTM F1160 ●
Abrasion Resistance per ASTM F1978 ●
Stereological Evaluation per ASTM F1854 ●

Construct Fatigue Testing

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Fatigue testing was performed on the worst case shoulder construct with anatomically relevant loading to demonstrate that the strength of the device exceeds that required for the intended use. The acceptance criteria were met.

Taper Disassembly Evaluation

A mechanical evaluation was conducted to study the dissociation of production equivalent tapers used on the humeral side of the subject device. Testing was conducted per ASTM F2009. The acceptance criteria were met.

Shelf Life Evaluation

A shelf life evaluation per ISO 11607-1 and ISO 11607-2 was completed on the packaging materials that make up the sterile barrier. A five year shelf life was established based on the resultant data.

Sterilization Validation

Sterilization validation was completed using the VDmax method specified in ISO 11137-1 and ISO 11137-2. The Sterility Assurance Level (SAL) was found to be 10-6.

Compatible Device Testing

The compatible devices that make up the total shoulder construct were tested, and the information provided in predicate device K202716. For the compatible glenoid, tests included polyethylene characterization, wear testing, loosening testing, torsional testing, and axial pullout testing.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Stemless Anatomic Shoulder System to the predicate device.

Conclusion:

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

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”