The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous 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 glenoid base plate 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.

Device Description

The Integra TITAN Reverse Shoulder System is a modular shoulder prosthesis system. The humeral components consist of humeral stems, varying heights of reverse bodies, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and 4 peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations.

AI/ML Overview

The provided document describes the Integra TITAN Reverse Shoulder System, a medical device. The information details nonclinical testing performed to establish substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical or AI-assisted diagnostic context.

Therefore, the following information, as requested in the prompt, is not available in the provided text:

A table of acceptance criteria and reported device performance (in a diagnostic context)
Sample size used for the test set and data provenance (for diagnostic performance)
Number of experts used to establish ground truth for the test set
Qualifications of those experts
Adjudication method
If a multi reader multi case (MRMC) comparative effectiveness study was done
Effect size of human readers improving with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a diagnostic algorithm
The sample size for the training set (for a diagnostic algorithm)
How the ground truth for the training set was established (for a diagnostic algorithm)

However, I can extract information regarding the nonclinical performance testing that was conducted for the device. The document explicitly states: "Clinical performance data were not necessary to support substantial equivalence." This means no human clinical trials (as one might expect a diagnostic AI to undergo) were presented for this 510(k) submission.

Here's what can be extracted about the device's nonclinical performance:

Nonclinical Testing and Acceptance Criteria:

The Integra TITAN Reverse Shoulder System underwent several nonclinical performance tests to confirm its ability to perform under expected clinical conditions. The acceptance criteria for each test are implicitly met as the summary states the "System met all acceptance criteria" or "is acceptable" for each respective test.

Test ID / Description	Reported Device Performance (Conclusion)
1. TP/TR -04-0172 rev A TSS Taper Axial Disassembly Force	The taper in the TITAN Total Shoulder System is identical to the taper in the Reverse Shoulder system; therefore, additional testing was not required. The test report concludes that the locking efficiency of the AOI taper is acceptable. (Previously submitted in K100448).
2. TP/TR-04-0245 Rev B TITAN Reverse Shoulder Body/Spacer to Liner Axial Disassembly Test	The objective of this test was to verify that the force required to disassemble the TITAN Reverse Shoulder System (RSS) humeral liner from the modular body or the humeral spacer exceeds a biomechanically justified worst-case load. The Spacer and Liner assemblies of the TITAN Reverse Shoulder System met all acceptance criteria.
3. TP/TR-04-0248 Dynamic Evaluation of Glenoid Baseplate Disassociation	The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) glenoid assembly does not loosen during cyclic loading representing one year of post-arthroplasty daily living. The TITAN Reverse Shoulder System Glenoid construct met all acceptance criteria.
4. TP/TR-04-0283 rev A RSS Fatigue Evaluation Test	The objective of this test was to verify that the modular TITAN Reverse Shoulder System (RSS) maintains functional integrity after enduring a challenging fatigue regimen representing 10 years of daily worst-case post-arthroplasty cyclic loading in a simulated biological corrosive environment. The TITAN Reverse Shoulder System met all acceptance criteria.
5. TP/TR-04-0254-01 TITAN Reverse Shoulder System Glenosphere-Baseplate Taper Axial Disassembly Force	The purpose of this test was to determine the force required to disassemble the Glenosphere/Baseplate taper junction of the Integra TITAN Reverse Shoulder System. Heuristic models of the Reverse glenosphere male taper and baseplate female taper were tested as per ASTM F2009-00(2011). The taper design for the Glenosphere-Baseplate junction of the TITAN Reverse Shoulder System met all acceptance criteria.
6. TP/TR-04-0281 Rev A Reverse Shoulder System Liner Rotational Resistance Test Protocol	The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) humeral liner could withstand worst-case torques created by rotation about the glenosphere without disassociating from the body implant or spacer implant. The rotational resistance at the interface of the Spacer and Liner of the TITAN Reverse Shoulder System met all acceptance criteria.
7. TP/TR-09-0082 Reverse Shoulder 4.5mm Screw Properties	The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 4.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 4.5mm screws met all acceptance criteria.
8. TP/TR-09-0083 Reverse Shoulder 5.5mm Screw Properties	The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 5.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 5.5mm screws met all acceptance criteria.
9. TR-09-0088 rev C Asymmatrix Coating Characteristics	The Asymmatrix coating (sintered asymmetrical titanium bead coating) used on the Humeral Bodies and Glenoid Baseplates meets the requirements of the appropriate FDA guidance documents for use in the Integra Reverse Shoulder System.
10. TR-09-0249 rev B RSS Range of Motion	This document verifies the range of motion of the TITAN Reverse Shoulder System in flexion, abduction, internal rotation, external rotation and extension. The range of motion of the TITAN Reverse Shoulder System meets the performance requirements. The testing was conducted on worst-case components or constructs according to standard test methods, where possible. (Details about the "performance requirements" for range of motion are not provided in this summary, but are stated as met).

Additional Notes:

Sample Size (for nonclinical tests): The document does not specify the exact sample sizes (number of units tested) for each nonclinical test, but refers to "worst-case components or constructs" being tested.
Data Provenance (for nonclinical tests): These are laboratory-based engineering tests, not clinical data from patients or a specific country.
Ground Truth (for nonclinical tests): The ground truth for these tests is based on established engineering principles, biomechanical justification, industry standards (e.g., ASTM F2009-00(2011)), and FDA guidance documents.
Training Set (for nonclinical tests): This concept does not apply to the nonclinical testing described. These are physical performance assessments against predefined engineering parameters.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Ascension Orthopedics, Incorporated Ms. Susan Walton Director, Regulatory Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754

Re: K130050

Trade/Device Name: Integra TITAN 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, KWS Dated: May 14, 2013 Received: May 17, 2013

Dear Ms. Walton:

This letter corrects our substantially equivalent letter of June 18, 2013.

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting (reporting of medical

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Page 2 - Ms. Susan Walton

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Indications for Use Statement

KISOOSO 510(K) Number:

Device Name: Integra TITAN Reverse Shoulder System

Indications for Use:

The glenoid base plate 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE-DO NOT-WRITE BELOW THIS LINE-CONTINUE-ON-ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Harren Frank Start StatesTE-Hanley1319-4 12-2 1-2
2415384 15- - - -પંDivisAdminું જુvices13Personal Production September 2017

1 of 1

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JUN 1 8 2013

	510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR	Ascension Orthopedics, Inc.A wholly owned division of Integra LifeSciences, Inc.8700 Cameron RoadAustin, TX 78754-3832
510(k) CONTACT:	Susan Waltonsusan.walton@integralife.comPhone: (512) 836-5001 x1591FAX (512) 836-6933
DATE PREPARED:	January 5, 2013
TRADE NAME:	Integra TITAN Reverse Shoulder System
COMMON NAME:	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
CLASSIFICATION:	21 CFR 888.3660 – Shoulder joint metal/polymer semi-constrained cemented prosthesis
PRODUCT CODE:	KWS
PANEL:	Orthopedic
PREDICATEDEVICES:	K081016	Promos Reverse Shoulder System	Smith & Nephew Inc.
	K113523 K110598	SMR Reverse Shoulder System	Lima Corporate S.P.A.
	K120174 K062250	Delta Xtend Reverse Shoulder System	DePuy, Inc.
	K041066	Encore Reverse Shoulder Prosthesis	DIO Surgical/Encore Medical

construct. The humeral components consist of humeral stems, varying heights of reversebodies, and humeral poly liners. The poly liners are available in varying thicknesses andconstraints to achieve stability and offset of the glenohumeral joint. The variable lengthreverse bodies and proximally-filling shape are designed to accommodate the natural humeralgeometry, providing stable fixation as well as proximal bone loading. The glenoid componentsare composed of a baseplate secured by a central compression screw and 4 peripheral screws,two of which can be locked. A glenosphere is attached to the baseplate via taper lock.Glenospheres are available in varying offsets and lateralizations.
The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff jointwith severe arthropathy or a previous failed joint replacement with a grossly deficient rotatorcuff joint. The patient's joint must be anatomically and structurally suited to receive the selectedimplants and a functional deltoid muscle is necessary to use the device.The glenoid base plate is intended for cementless application with the addition of screws forfixation. The humeral stem is indicated for cemented or uncemented use and the humeral bodycomponent is intended for cementless use.

construct. The humeral components consist of humeral stems, varying heights of reversebodies, and humeral poly liners. The poly liners are available in varying thicknesses andconstraints to achieve stability and offset of the glenohumeral joint. The variable lengthreverse bodies and proximally-filling shape are designed to accommodate the natural humeralgeometry, providing stable fixation as well as proximal bone loading. The glenoid componentsare composed of a baseplate secured by a central compression screw and 4 peripheral screws,two of which can be locked. A glenosphere is attached to the baseplate via taper lock.Glenospheres are available in varying offsets and lateralizations.

The Titan™ Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff jointwith severe arthropathy or a previous failed joint replacement with a grossly deficient rotatorcuff joint. The patient's joint must be anatomically and structurally suited to receive the selectedimplants and a functional deltoid muscle is necessary to use the device.The glenoid base plate is intended for cementless application with the addition of screws forfixation. The humeral stem is indicated for cemented or uncemented use and the humeral bodycomponent is intended for cementless use.

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SUMMARY OFTECHNOLOGICALCHARACTERISTICS	Feature/ Characteristic	TITAN Reverse Shoulder System(Subject Device)
	Implant Design	• Modular design comprised of humeral stem, reversebody, polyethylene insert, glenoid base, eccentric andconcentric glenosphere, glenoids baseplate and bonescrew.
	Components - Humeral Stem
	Materials	• Cobalt Chromium alloy - cemented• Titanium alloy - press fit
	Sizes	90mm Length Press Fit Stem• 11 diameters (6-16mm)90mm Length Cemented Stem• 5 diameters (6-14mm)Revision Stems• Two lengths - 125 and 165mm• 4 diameters (8-14mm)
	Components - Reverse Body
	Materials	• Titanium alloy with porous coating
	Sizes	142.5° inclination angle available in 3 body heights
	Components - Insert
	Materials	• UHMWPE
	Sizes	• Standard - 4 sizes• Retentive - 4 sizes
	Components - Baseplate and Screws
	Materials	• Titanium alloy with asymmetrical titanium beadsintered coating
	Sizes	• Two lengths• Convex back• Titanium central compression screw• Titanium peripheral polyaxial locking and non-lockingscrews
	Components - Glenosphere
	Materials	• Cobalt chromium alloy
	Sizes	• Concentric design in 2 sizes, lateralized• Eccentric design in 3 sizes, lateralized
	Sterilization	• Provided sterile• Gamma radiation
NONCLINICALTESTING		The Integra TITAN Reverse Shoulder System has undergone performance testing to confirm thesystem's ability to perform under expected clinical conditions.
	1.	TP/TR -04-0172 rev A TSS Taper Axial Disassembly ForceThis test report was previously submitted in K100448. The taper in the TITAN TotalShoulder System is identical to the taper in the Reverse Shoulder system thereforeadditional testing was not required. The test report concludes that the lockingefficiency of the AOI taper is acceptable.
	2.	TP/TR-04-0245 Rev B TITAN Reverse Shoulder Body/Spacer to Liner Axial DisassemblyTestThe objective of this test was to verify that the force required to disassemble the TITANReverse Shoulder System (RSS) humeral liner from the modular body or the humeralspacer exceeds a biomechanically justified worst case load. The Spacer and Linerassemblies of the TITAN Reverse Shoulder System met all acceptance criteria.
3. TP/TR-04-0248 Dynamic Evaluation of Glenoid Baseplate Disassociation	The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) glenoid assembly does not loosen during cyclic loading representing one year of post-arthroplasty daily living. The TITAN Reverse Shoulder System Glenoid construct met all acceptance criteria.
4. TP/TR-04-0283 rev A RSS Fatigue Evaluation Test	The objective of this test was to verify that the modular TITAN Reverse Shoulder System (RSS) maintains functional integrity after enduring a challenging fatigue regimen representing 10 years of daily worst case post-arthroplasty cyclic loading in a simulated biological corrosive environment. The TITAN Reverse Shoulder System met all acceptance criteria.
5. TP/TR-04-0254-01 TITAN Reverse Shoulder System Glenosphere-Baseplate Taper Axial Disassembly Force	The purpose of this test was to determine the force required to disassemble the Glenosphere/Baseplate taper junction of the Integra TITAN Reverse Shoulder System. Heuristic models of the Reverse glenosphere male taper and baseplate female taper were tested as per ASTM F2009-00(2011). The taper design for the Glenosphere-Baseplate junction of the TITAN Reverse Shoulder System met all acceptance criteria.
6. TP/TR-04-0281 Rev A Reverse Shoulder System Liner Rotational Resistance Test Protocol	The objective of this test was to verify that the TITAN Reverse Shoulder System (RSS) humeral liner could withstand worst case torques created by rotation about the glenosphere without disassociating from the body implant or spacer implant. The rotational resistance at the interface of the Spacer and Liner of the TITAN Reverse Shoulder System met all acceptance criteria.
7. TP/TR-09-0082 Reverse Shoulder 4.5mm Screw Properties	The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 4.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 4.5mm screws met all acceptance criteria.
8. TP/TR-09-0083 Reverse Shoulder 5.5mm Screw Properties	The purpose of this test was to verify that the TITAN Reverse Shoulder System (RSS) 5.5mm screw meets all criteria for its intended use. These criteria include driving properties, torsional properties and axial pullout strength. The RSS 5.5mm screws met all acceptance criteria.
9. TR-09-0088 rev C Asymmatrix Coating Characteristics	The Humeral Bodies and Glenoid Baseplates of the Integra TITAN Reverse Shoulder System will be coated with Asymmatrix coating, a sintered asymmetrical titanium bead coating manufactured by Orchid Orthopedic Solutions, Memphis, Tennessee. The purpose of this document is to demonstrate that this coating meets the requirements for its intended use as provided in two FDA guidance documents. The Asymmatrix coating meets the requirements of the appropriate FDA guidance documents for use in the Integra Reverse Shoulder System.
10. TR-09-0249 rev B RSS Range of Motion	This document verifies the range of motion of the TITAN Reverse Shoulder System in flexion, abduction, internal rotation, external rotation and extension. The range of motion of the TITAN Reverse Shoulder System meets the performance requirements. The testing was conducted on worst case components or constructs according to standard test
	methods, where possible.
CLINICALPERFORMANCEDATA:	Clinical performance data were not necessary to support substantial equivalence.
BASIS OFSUBSTANTIALEQUIVALENCE:	The TITAN Reverse Shoulder system is similar to the predicate devices in terms of indicationsfor use, intended use and fundamental scientific technology. Performance data demonstratesthat the subject device design is expected to perform as indicated.

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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.”