(160 days)
No
The summary describes a mechanical shoulder prosthesis system and its components. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices. The performance studies focus on mechanical testing of the device components.
Yes
The device is a modular shoulder prosthesis system indicated for use in specific joint conditions, aiming to replace or reconstruct the joint, which is a therapeutic intervention.
No
The device is a modular shoulder prosthesis system, indicated for use in surgical replacement of the shoulder joint, and its description and performance studies focus on mechanical integrity and function, not diagnosis.
No
The device description clearly states it is a "modular shoulder prosthesis system" consisting of physical components like humeral stems, bodies, liners, glenoid baseplates, and glenospheres. The performance studies also focus on the mechanical properties and performance of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder prosthesis, which are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue) or providing information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on the mechanical integrity and function of the implant itself, not on diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
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.
Product codes
PHX, KWS
Device Description
The Integra TITAN Reverse Shoulder System consists of a modular shoulder prosthesis. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Integra TITAN Reverse Shoulder System has undergone performance testing to confirm the system's ability to perform under expected clinical conditions.
- TP/TR -04-0172 rev A TSS Taper Axial Disassembly Force: The test report concludes that the locking efficiency of the AOI taper is acceptable.
- TP/TR-04-0245 Rev B TITAN Reverse Shoulder Body/Spacer to Liner Axial Disassembly Test: The Spacer and Liner assemblies of the TITAN Reverse Shoulder System met all acceptance criteria.
- TP/TR-04-0248 Dynamic Evaluation of Glenoid Baseplate Disassociation: The TITAN Reverse Shoulder System Glenoid construct met all acceptance criteria.
- TP/TR-04-0283 rev A RSS Fatigue Evaluation Test: The TITAN Reverse Shoulder System met all acceptance criteria.
- TP/TR-04-0254-01 TITAN Reverse Shoulder System Glenosphere-Baseplate Taper Axial Disassembly Force: The taper design for the Glenosphere-Baseplate junction of the TITAN Reverse Shoulder System met all acceptance criteria.
- TP/TR-04-0281 Rev A Reverse Shoulder System Liner Rotational Resistance Test Protocol: The rotational resistance at the interface of the Spacer and Liner of the TITAN Reverse Shoulder System met all acceptance criteria.
- TP/TR-09-0082 Reverse Shoulder 4.5mm Screw Properties: The RSS 4.5mm screws met all acceptance criteria.
- TP/TR-09-0083 Reverse Shoulder 5.5mm Screw Properties: The RSS 5.5mm screws met all acceptance criteria.
- TR-09-0088 rev C Asymmatrix Coating Characteristics: The Asymmatrix coating meets the requirements of the appropriate FDA guidance documents for use in the Integra Reverse Shoulder System.
- TR-09-0249 rev B RSS Range of Motion: The range of motion of the TITAN Reverse Shoulder System meets the performance requirements.
Clinical performance data were not necessary to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081016, K113523, K110598, K120174, K062250, K041066
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
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
1
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
2
Indications for Use
Indications for Use Statement
KISOOSO 510(K) Number:
Device Name: Integra TITAN Reverse Shoulder System
Indications for Use:
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.
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)
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| 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS | |||
|---|---|---|---|
| SPONSOR | Ascension Orthopedics, Inc. | ||
| A wholly owned division of Integra LifeSciences, Inc. | |||
| 8700 Cameron Road | |||
| Austin, TX 78754-3832 | |||
| 510(k) CONTACT: | Susan Walton | ||
| susan.walton@integralife.com | |||
| Phone: (512) 836-5001 x1591 | |||
| FAX (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 | ||
| PREDICATE | |||
| DEVICES: | 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 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. |
|---|
| 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. |
.
.
. .
4
| SUMMARY OF
TECHNOLOGICAL
CHARACTERISTICS | Feature/ Characteristic | TITAN Reverse Shoulder System
(Subject Device) |
|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Implant Design | • Modular design comprised of humeral stem, reverse
body, polyethylene insert, glenoid base, eccentric and
concentric glenosphere, glenoids baseplate and bone
screw. |
| | 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 bead
sintered coating |
| | Sizes | • Two lengths
• Convex back
• Titanium central compression screw
• Titanium peripheral polyaxial locking and non-locking
screws |
| | Components - Glenosphere | |
| | Materials | • Cobalt chromium alloy |
| | Sizes | • Concentric design in 2 sizes, lateralized
• Eccentric design in 3 sizes, lateralized |
| | Sterilization | • Provided sterile
• Gamma radiation |
| NONCLINICAL
TESTING | | The Integra TITAN Reverse Shoulder System has undergone performance testing to confirm the
system's ability to perform under expected clinical conditions. |
| | 1. | TP/TR -04-0172 rev A TSS Taper Axial Disassembly Force
This test report was previously submitted in K100448. 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. |
| | 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 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. | |
| CLINICAL
PERFORMANCE
DATA: | Clinical performance data were not necessary to support substantial equivalence. | |
| BASIS OF
SUBSTANTIAL
EQUIVALENCE: | The TITAN Reverse Shoulder system is similar to the predicate devices in terms of indications
for use, intended use and fundamental scientific technology. Performance data demonstrates
that the subject device design is expected to perform as indicated. | |
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