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 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 proximal humerus (with Standard or Long Stems)
Revisions of previously failed shoulder joint replacements

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.

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), 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 text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.

The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."

The non-clinical testing performed includes:

Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
Porous Structure Characterization: Identical to previously cleared devices.
Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.

These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.

Summary

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April 21, 2022

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

Re: K212737

Trade/Device Name: INHANCE™ Reverse Shoulder System 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, PAO, HSD Dated: August 27, 2021 Received: August 30, 2021

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 (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.

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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 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,

Lixin Liu, Ph.D. 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

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Indications for Use

510(k) Number (if known) K212737

Device Name INHANCE™ Reverse Shoulder System

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 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 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 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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510(k) Summary
Prepared:	March 18, 2022
Submitter:	DePuy Ireland UCLoughbegRingaskiddyCO. CORK Munster, IE
Contact:	Russ ParrottChief Technology OfficerPhone: 574.527.2864russ.parrott@igniteorthopedics.com
Proprietary Name:	INHANCE™ Reverse Shoulder System
Common Name:	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-Constrained, Porous Coated, Uncemented Prosthesis (21 CFR §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, Semi-Constrained, Metal/Polymer + Additive Cemented (21 CFR §888.3660); Class II
	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (21 CFR §888.3690); Class II
Product Codes:	PHX, MBF, KWT, KWS, PAO, HSD

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Predicate Devices:

K193373 (Primary) - Comprehensive Reverse Shoulder; Biomet, Inc. K202716 - Ignite Anatomic Shoulder System; Ignite Orthopedics LLC K060692 - Comprehensive Primary Shoulder Stems, Biomet, Inc.

Reference Devices:

K181611 Comprehensive Reverse Shoulder System; Biomet, Inc.
K 130048 Reverse Shoulder Prosthesis Monoblock: ENCORE Medical, L.P.
K172351 AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert; ENCORE Medical, L.P.
K130050 Titan Reverse Shoulder System; Ascension Orthopedic
K161742 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid; Tornier, Inc.
K183077 Delta XTEND Reverse Shoulder System; DePuy (Ireland)
K062250 Delta XTEND Reverse Shoulder System; DePuy Orthopaedics, Inc.
K120174 Delta XTEND Reverse Shoulder; DePuy France
K081620 Modification to Delta XTEND Reverse Shoulder System; DePuy Orthopaedics. Inc.
K071379 Delta XTEND Reverse Shoulder Modular Stem; DePuy Orthopaedics, Inc.
K122698 Aequalis Ascend Flex Shoulder System; Tornier, Inc.
K052906 Zimmer Trabecular Metal Reverse Shoulder System; Zimmer, Inc.

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),

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a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

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 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.

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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 proximal humerus (with Standard or Long Stems)
· Revisions of previously failed shoulder joint replacements

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 implant and associated instruments within the INHANCE™ Reverse Shoulder System are substantially equivalent to the predicate devices in terms to its intended use and indications, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise different questions of safety and effectiveness.

Non-Clinical Testing:

The INHANCE™ Reverse Shoulder System underwent non-clinical testing and analyses to support a determination of substantial equivalence to the predicate device. The following were completed:

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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.

Construct Fatigue Testing

Construct fatigue testing was performed per ASTM F1378. The acceptance criteria were met.

Construct Loosening and Disassociation

The INHANCETM Reverse Shoulder System was evaluated for loosening and disassociation per ASTM F2028-17. The acceptance criteria 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 is identical to the porous structure that was applied to the implants cleared under K202716 (Ignite Anatomic Shoulder System) and K203108 (Ignite Stemless Anatomic Shoulder System).

Characterization of VE-UHMWPE

The Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) material used for the Liners of the INHANCE™ Reverse Shoulder is identical to the VE UHMWPE material that was used on the devices cleared under K202716 (Ignite Anatomic Shoulder System). The material was fully characterized per FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices-Guidance for Industry and Food and Drug Administration Staff" in K202716.

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Evaluation of Wear Rate

Wear testing of the Vit-E UHMWPE liners was completed on a joint simulator under pristine and abrasive conditions. Prior to wear testing, the liners were accelerated aged per ASTM F2003. The resulting wear rate was lower than that of a predicate device. The acceptance criteria were met. Micro-CT assessment of wear features on the humeral liners was conducted following abrasive wear testing.

MRI Compatibility

Quantitative data was obtained to inform Magnetic Resonance Imaging (MRI) Conditional Labeling through the following evaluations:

Force: Static Magnetic Field Induced Displacement Force per ASTM F2052-15 ●
Torque: Static Magnetic Field Induced Torque per ASTM F2213-17 ●
Heating: Radiofrequency field (RF) induced heating per ASTM F2182-19e2 ●
Image Quality: Susceptibility induced image artifacts per ASTM F2119-07

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 10-9.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices.

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.”