(70 days)
No
The document describes a system of physical implants for shoulder replacement surgery and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a total shoulder replacement system indicated for treating various painful and disabling joint diseases of the shoulder, including aseptic necrosis, degenerative arthritis, and fractures. Its purpose is to alleviate symptoms and restore function, which aligns with the definition of a therapeutic device.
No
The device described is a shoulder replacement system (prosthetic implant), which is a treatment device, not a diagnostic one. Its purpose is to replace parts of the shoulder joint, not to identify or characterize a medical condition.
No
The device description clearly outlines physical components such as humeral stems, glenoid components, screws, and other implantable parts for shoulder replacement surgery. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the ReUnion RFX System, ReUnion RSA Shoulder System, and ReUnion TSA System are composed of components like humeral stems, glenoid components, humeral heads, etc. These are implants designed to replace or repair parts of the shoulder joint.
- Intended Use: The intended use describes the conditions for which the device is indicated, such as aseptic necrosis, arthritis, fractures, and revisions of previous shoulder replacements. These are all conditions treated by surgically implanting the device.
The device is a surgical implant used in orthopedic procedures, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The ReUnion RFX System includes a Reversible Fracture Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended use only.
When used with ReUnion TSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement:
- · Aseptic necrosis of the humeral head.
- · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, or posttraumatic arthritis.
- · Proximal humeral fractures and/or dislocation.
- · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
- · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
The glenoid components are intended for cemented use only.
When used with ReUnion RSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
· Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
- Proximal humeral fractures
- · Revisions of previously failed shoulder joint replacements
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically suited to receive the implant(s).
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).
- · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
- Proximal humeral fracture.
- · Revision of previously failed shoulder joint replacement.
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
The Humeral Stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.
In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator ouff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
For use as a Hemi or Total Shoulder Replacement
· Aseptic necrosis of the humeral head.
· Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis.
• Proximal humeral fracture and/or dislocation.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
Product codes
KWS, PHX, HSD
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components to the ReUnion RSA, TSA and RFX Systems, previously cleared via K161863.
The ReUnion Reversible Fracture System consists of a humeral fracture stem component which may be used in conjunction with TSA or RSA humeral and glenoid components for conventional total shoulder arthroplasty or reverse shoulder arthroplasty. It may also be used in conjunction with TSA humeral components to articulate directly with the anatomic glenoid in a hemi-shoulder application. The device contains various number of suture holes. The stems have a female taper on the proximal end of the shaft to accept TSA and RSA Gleno-humeral components. It is designed to be used in cemented applications only.
The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a humeral cup, humeral insert, glenosphere, glenoid baseplate and screws. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.
The Reunion Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular humeral neck adapter, single radius humeral heads, and self-pressurizing glenoids (SPG). The humeral stem is offered in both cemented and cementless designs. The cementless humeral stem design features a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and the cemented humeral stems have no coating at the proximal end. These humeral stems were designed to mate with the subject single radius humeral heads or the modular neck adapter, for compatibility with other marketed humeral heads. The self-pressuring glenoids (SPG) mate with the single radius heads. The SPGs are offered in both pegged and keeled configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical laboratory testing was not required for this submission.
Clinical testing was not required for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Stryker ReUnion Reversible Fracture System, ReUnion Reverse Shoulder Arthroplasty System and ReUnion Total Shoulder Arthroplasty System: K161863
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/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The address is printed in a simple, sans-serif font.
Stryker Trauma AG Tina Mornak Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
October 2, 2017
Re: K172210
Trade/Device Name: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
Regulatory Class: Class II Product Code: KWS, PHX, HSD Dated: July 20, 2017
Received: July 24, 2017
Dear Tina Mornak:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
1
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 devicerelated 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 (DICE) 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" (21 CFR 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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172210
Device Name Reversible Fracture System (RFX)
Indications for Use (Describe)
The ReUnion RFX System includes a Reversible Fracture Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended use only.
When used with ReUnion TSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement:
- · Aseptic necrosis of the humeral head.
- · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, or posttraumatic arthritis.
- · Proximal humeral fractures and/or dislocation.
- · Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
- · Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
The glenoid components are intended for cemented use only.
When used with ReUnion RSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
· Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
- Proximal humeral fractures
- · Revisions of previously failed shoulder joint replacements
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a
3
grossly deficient rotator cuff with severe arthropathy failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically suited to receive the implant(s).
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
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)
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172210
Device Name
ReUnion Reverse Shoulder Arthroplasty System (RSA)
Indications for Use (Describe)
The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).
- · Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
- Proximal humeral fracture.
- · Revision of previously failed shoulder joint replacement.
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
The Humeral Stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.
In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator ouff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ReUnion Total Shoulder Arthroplasty System (TSA)
Indications for Use (Describe) For use as a Hemi or Total Shoulder Replacement
· Aseptic necrosis of the humeral head.
· Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis.
• Proximal humeral fracture and/or dislocation.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
· Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural grovides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
K172210 Page 1/5
510(k) Summary Proprietary Name: ReUnion Reversible Fracture System ReUnion Reverse Shoulder Arthroplasty System ReUnion Total Shoulder Arthroplasty System Common Name: Prosthesis, shoulder, semi-constrained, metal/polymer cemented (21 CFR 888.3660) Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690) Regulation Description: Shoulder joint metal/polymer semi-constrained cement prosthesis (21 CFR 888.3660) Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690) Regulation Number: 21 CFR 888.3660 21 CFR 888.3690 Product Code: KWS, PHX, HSD Class II Device Class: Sponsor: Stryker GmbH Bohnackerweg l 2545 Selzach / Switzerland Contact Person: Tina Mornak Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430 Phone: 201-831-6365 Fax: 201-831-6500 Date Prepared: July 20, 2017 Primary Predicate: Stryker ReUnion Reversible Fracture System, ReUnion Reverse Shoulder Arthroplasty System and ReUnion Total
Shoulder Arthroplasty System: K161863
7
Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components to the ReUnion RSA, TSA and RFX Systems, previously cleared via K161863.
ReUnion Reversible Fracture System (RFX)
The ReUnion Reversible Fracture System consists of a humeral fracture stem component which may be used in conjunction with TSA or RSA humeral and glenoid components for conventional total shoulder arthroplasty or reverse shoulder arthroplasty. It may also be used in conjunction with TSA humeral components to articulate directly with the anatomic glenoid in a hemi-shoulder application. The device contains various number of suture holes. The stems have a female taper on the proximal end of the shaft to accept TSA and RSA Gleno-humeral components. It is designed to be used in cemented applications only.
ReUnion Reverse Shoulder Arthroplasty System (RSA)
The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a humeral cup, humeral insert, glenosphere, glenoid baseplate and screws. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.
ReUnion Total Shoulder Arthroplasty System (TSA)
The Reunion Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular humeral neck adapter, single radius humeral heads, and self-pressurizing glenoids (SPG). The humeral stem is offered in both cemented and cementless designs. The cementless humeral stem design features a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and the cemented humeral stems have no coating at the proximal end. These humeral stems were designed to mate with the subject single radius humeral heads or the modular neck adapter, for compatibility with other marketed humeral heads. The self-pressuring glenoids (SPG) mate with the single radius heads. The SPGs are offered in both pegged and keeled configurations.
Indications for Use
ReUnion Reverse Shoulder Arthroplasty System (RSA)
The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).
• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
- Proximal humeral fracture.
- · Revision of previously failed shoulder joint replacement.
8
K172210 Page 3/5
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
The Humeral Stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.
In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthroplasty failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
ReUnion Total Shoulder Arthroplasty System (TSA)
For use as a Hemi or Total Shoulder Replacement
- · Aseptic necrosis of the humeral head.
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis.
- Proximal humeral fracture and/or dislocation.
• Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.
In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
ReUnion Reversible Fracture System (RFX)
The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
When used with ReUnion TSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement:
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· Aseptic necrosis of the humeral head.
• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
· Proximal humeral fractures and/or dislocation.
• Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty to a
hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
The glenoid components are intended for cemented use only.
When used with ReUnion RSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
• Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
- Proximal humeral fractures
- · Revisions of previously failed shoulder joint replacements
In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
Summary of Technologies
A comparison of the systems demonstrated that the subject ReUnion RFX, RSA and TSA Systems are substantially equivalent to the previously cleared ReUnion RFX, RSA and TSA Systems (K161863) in regards to intended use, material, design, and operational principles.
Non-Clinical Testing
Non-clinical laboratory testing was not required for this submission.
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K172210 Page 5/5
Traditional 510(k) Premarket Notification
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The subject ReUnion RFX, RSA and TSA Systems are substantially equivalent to the predicate ReUnion RFX, RSA and TSA Systems previously cleared via K161863.