The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid
arthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,
separated from its blood supply or where the surgeon's experience indicates that alternative methods
of treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not
acceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:
Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended for
cemented use only.
The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe
arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint
must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is
necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including
proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to
gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of
screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body
component is intended for cementless use.
The Ascension HRA System is intended for resurfacing of the humeral head due to:
Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,
osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:
Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:
Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,
crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

joint destruction or subluxation visible on x-ray
resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone
stock inadequate.

Device Description

The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.
There are no other changes proposed in this submission. The following aspects of the devices are not impacted by
the additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.
• Intended Use/Indications for Use
• Contraindications
• Design and Dimensions
• Performance Specifications
• Materials
• Biocompatibility

AI/ML Overview

The provided document is a 510(k) summary for the Smith & Nephew TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), and Katalyst Bipolar Radial Head System (Katalyst).

However, the document does not contain information about an AI/ML-based medical device or any study demonstrating its performance against acceptance criteria. Instead, it focuses on the addition of MR Conditional information to the labeling of existing predicate devices. The "Non-Clinical Performance Data" section describes the testing performed to ensure MR compatibility, which is a different type of performance testing than what would be expected for an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML-based medical device from this document. The document describes a traditional medical device submission for orthopedic implants.

To answer your request, if this were a document about an AI/ML device, I would look for sections describing:

Clinical Performance Study: Details about how the AI/ML model's output was evaluated, often involving a comparison to a ground truth or human expert readings.
Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, accuracy.
Acceptance Criteria: Predetermined thresholds for these metrics that the device must meet to be considered effective.
Test Set Description: Information on the size, source, and characteristics of the data used for testing.
Ground Truth Establishment: How the definitive diagnosis or finding for the test data was determined (e.g., expert consensus, pathology, long-term follow-up).
Reader Study Information: If applicable, details about human reader performance with and without AI assistance.

Since the provided document does not contain this type of information, I must state that it is not possible to fulfill the request based on the given input.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

March 11, 2022

Smith & Nephew, Inc. Stephanie Rincones Regulatory Affairs Specialist 11101 Metric Blvd Austin, Texas 78758

Re: K213827

Trade/Device Name: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS, HSD, PHX, KWI Dated: February 9, 2022 Received: February 10, 2022

Dear Stephanie Rincones:

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 Ouality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K213827

Device Name TITAN Total Shoulder System

Indications for Use (Describe)

The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:

· Severely painful and or disabled joint resulting from osteoarthritis or rheumatoid arthritis.

· Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its

blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.

· Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Shoulder Hemiarthroplasty is also indicated for:

· Ununited humeral head fractures.
· Avascular necrosis of the humeral head.
· Rotator cuff arthropathy.
· Deformity and/or limited motion.

The humeral component is intended or uncemented use. The glenoid component is intended for cemented 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.

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

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510(k) Number (if known) K213827

Device Name TITAN Reverse Shoulder System

Indications for Use (Describe)

The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

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.

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

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

510(k) Number (if known) K213827

Device Name

TITAN Humeral Resurfacing Arthroplasty System

Indications for Use (Describe)

The Ascension HRA System is intended for resurfacing of the humeral head due to:

Patients disabled by either non-inflammatory arthritis (i.e. theumatoid arthritis, osteoarthritis and avascular necrosis)
Mild or moderate humeral head deformity and/or limited motion
Post-traumatic arthritis
Malunions of the humeral head
Acute fractures of the humeral head
Patients with an intact or reparable rotator cuff

Contraindications:

Infection, sepsis, and osteomyelitis
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Revision procedures where other devices or treatments have failed

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.

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

{5}------------------------------------------------

510(k) Number (if known) K213827

Device Name Modular Radial Head System

Indications for Use (Describe)
--------------------------------	--

The Ascension Modular Radial Head is intended for:

· Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

joint destruction or subluxation visible on x-ray
resistance to conservative treatment
· Primary replacement after fracture of the radial head
· Symptomatic sequelae after radial head resection
· Revision following failed radial head arthroplasty

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.

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

{6}------------------------------------------------

510(k) Number (if known) K213827

Device Name Katalyst Bipolar Radial Head System

Indications for Use (Describe)

The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.

Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.

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.

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

{7}------------------------------------------------

510(k) Summary

Date	March 11, 2022
Submitter	Ascension Orthopedics, Inc.11101 Metric Blvd.Austin, TX 78758
Point of Contact	Stephanie RinconesRegulatory Affairs Specialist11101 Metric Blvd.Austin, TX 78758737-270-8239
Review Panel	Orthopedic
Trade Name	1. TITAN Total Shoulder System (TSS)2. TITAN Reverse Shoulder System (RSS)3. TITAN Humeral Resurfacing Arthroplasty System (HRA)4. Modular Radial Head System (MRH)5. Katalyst Bipolar Radial Head System (Katalyst)
Common Name	1. Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2. Shoulder Prosthesis, Reverse Configuration3. Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented4. Prosthesis, Elbow, Hemi-, Radial, Polymer5. Prosthesis, Elbow, Hemi-, Radial, Polymer
Product Code,ClassificationName (Regulation)	1. KWS, Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660)2. HSD, Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690)PHX, Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660)3. HSD, Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690)4. KWI, Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)5. KWI, Elbow joint radial (hemi-elbow) polymer prosthesis (21 CFR 888.3170)
Classification	Class II
Predicate Device	Primary Predicate:1. K142413 - TSS (Line Extension)Additional Predicates:1. K100448 – TSS (Original)K112438 - TSS (Line Extension)K152047 - TSS (Line Extension)2. K161189 - RSS (Indication Add)K173717 - RSS (Design Change)K181999 - RSS (Line Extension)K190588 - RSS (Line Extension)3. K062861 - HRA4. K032686 - MRH5. K032806 - Katalyst
Device Description	The purpose of this submission is the addition of MR Conditional information to the labeling of the predicate devices.There are no other changes proposed in this submission. The following aspects of the devices are not impacted bythe additional labeling and remain identical to the predicate devices as cleared in their respective 510(k)s.• Intended Use/Indications for Use• Contraindications• Design and Dimensions• Performance Specifications• Materials• Biocompatibility

Intended Use/Indications for Use	1. The TITAN Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoidarthritis.Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted,separated from its blood supply or where the surgeon's experience indicates that alternative methodsof treatment are unsatisfactory.Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are notacceptable (e.g., revision of a failed primary component).Shoulder Hemiarthroplasty is also indicated for:Ununited humeral head fractures.Avascular necrosis of the humeral head.Rotator cuff arthropathy.Deformity and/or limited motion.The humeral component is intended for cemented or uncemented use. The glenoid component is intended forcemented use only.2. The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severearthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's jointmust be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle isnecessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures includingproximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due togross rotator cuff deficiency. The glenoid baseplate is intended for cementless application with the addition ofscrews for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral bodycomponent is intended for cementless use.3. The Ascension HRA System is intended for resurfacing of the humeral head due to:Patients disabled by either non-inflammatory or inflammatory arthritis (i.e., rheumatoid arthritis,osteoarthritis and avascular necrosis)Mild or moderate humeral head deformity and/or limited motionPost-traumatic arthritisMalunions of the humeral headAcute fractures of the humeral headPatients with an intact or reparable rotator cuffContraindications:Infection, sepsis, and osteomyelitisOsteoporosisMetabolic disorders which may impair bone formationOsteomalaciaRapid joint destruction, marked bone loss or bone resorption apparent on roentgenogramRevision procedures where other devices or treatments have failed4. The Ascension Modular Radial Head is intended for:Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain,crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:- joint destruction or subluxation visible on x-ray- resistance to conservative treatmentPrimary replacement after fracture of the radial headSymptomatic sequelae after radial head resectionRevision following failed radial head arthroplasty5. The Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bonestock inadequate.

Non-ClinicalPerformance Data	Non-clinical Magnetic Resonance Imaging (MRI) testing performed on the worst-case devices determined that thedevices are MR Conditional in accordance with ASTM F2503 (Standard Practice for Marking Medical Devices andOther Items for Safety in the Magnetic Resonance Environment) and FDA Guidance (Testing and Labeling MedicalDevices for Safety in the Magnetic Resonance (MR) Environment).MRI testing addressed the following:1. Magnetically Induced Displacement Force (ASTM F2052)2. Magnetically Induced Toque (ASTM F2213)3. RF-Induced Heating (ASTM F2182)4. Image Artifact (ASTM F2119)
Conclusion	The completed MR compatibility testing establishes the conditional safety and compatibility of the passive implantdevices in the MR environment, and supports the addition of MR Conditional labeling to the devices.

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510(k) Summary

Smith Nephew

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.”