(140 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 indicated for use as a shoulder replacement for various joint diseases, fractures, and revisions, which are conditions addressed by therapeutic interventions.
No
Explanation: The provided text describes the ReUnion RFX System as an orthopedic implant for shoulder replacement, including its components, indications for use (e.g., aseptic necrosis, arthritis, fractures), and design specifications. It is a therapeutic device, not one that performs diagnosis.
No
The device description clearly outlines physical components made of materials like Ti-6Al-4V, cobalt chrome, and polyethylene, which are implanted into the body. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a shoulder replacement system used for surgical implantation to treat various shoulder conditions like arthritis, fractures, and failed previous surgeries. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details the physical components of the shoulder replacement system (stems, cups, baseplates, screws, etc.) and the materials they are made from. This aligns with a surgical implant, not a device used to perform tests on biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening of diseases or conditions in vitro (outside the body)
The device is a medical device intended for surgical implantation to restore function and alleviate pain in the shoulder joint.
N/A
Intended Use / Indications for Use
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 and 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, rheumatoid arthritis, or post- traumatic arthritis.
- Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthrodesis or alternative reconstructive 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 and Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral and 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.
ReUnion Reverse 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 and structurally 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 cuff 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).
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 post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation.
- Clinical management problems where arthrodesis or alternative reconstructive 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, 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, HSD
Device Description
ReUnion Reversible Fracture System (RFX)
The ReUnion Reversible Fracture System consists of various length and diameter stems. The stems are made from Ti-6Al-4V according to ASTM F136 and have a Ti-plasma spray and hydroxyapatite (HA) coating on the proximal end of the shaft. 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 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, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. 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 (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 will be manufactured from titanium alloy according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and be offered in 7mm-17mm distal diameters in Imm increments. The cemented humeral stems will have no coating at the proximal end and offered in 6mm-15mm distal diameters in lmm increments and includes 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius humeral heads or the modular neck adapter. manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self-pressuring glenoids (SPG) will be manufactured from X3® polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm- 56mm spherical diameters in 4mm increments.
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
Not Found
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
Bench Testing: Bench testing according to ASTM F2028. This discussion is captured in Section 020 titled "Performance Testing - Bench" Testing to determine the compatibility of the system in an MR environment was also performed. These tests included an assessment of: . Magnetically Induced Displacement Force per ASTM F2052 ● Magnetically Induced Torque per ASTM F2213 ● Heating by RF Fields per ASTM F2182 . Image Artifacts per ASTM F 2119 Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of ≤ 20EU/Device. Animal Testing: Animal testing was not required for this submission. Clinical Testing: Clinical testing was not required for this submission.
Key Metrics
Not Found
Predicate Device(s)
Aequalis Reverse Fracture System (K112144), ReUnion Total Shoulder Arthroplasty (TSA) System (K103835)
Reference Device(s)
ReUnion RSA Shoulder System (K130895), Solar ReUnion Fracture Stem (K062113), Global Unite Shoulder System (K133834)
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 features a stylized eagle with three heads in profile, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2016
Stryker GmbH Mr. Saad Attiyah Senior Manager, Reg Affairs Bohnackerweg 1 2545 Selzach, Switzerland 2545 CH
Re: K161863
Trade/Device Name: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: October 20, 2016 Received: October 24, 2016
Dear Mr. Attiyah:
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 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
1
the quality systems (OS) 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" (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 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,
VincentJ. Devlin -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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161863
Device Name ReUnion 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 for cemented use only.
When used with ReUnion TSA Humeral and 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 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 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 and Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral and 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 and structurally 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) K161863
Device Name ReUnion Reverse 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 ) |
|---|
| ---------------------------------------------------------- |
|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.
5
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161863
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 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 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 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
7
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."
8
Section 7. 510(k) Summary
| Submitter: | Stryker GmbH
Bohnackerweg 1
2545 Selzach
Switzerland |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Saad Attiyah
Senior Regulatory Affairs Manager
Phone: 201-831-5655
Fax: 201-831-4691 |
| Establishment Number
Date Prepared: | 8031020
June 23, 2016 |
| Name of Devices: | 1. ReUnion Reversible Fracture System (RFX)
2. ReUnion Reverse Arthroplasty System (RSA)
3. ReUnion Total Shoulder Arthroplasty System (TSA) |
| Common or Usual Name | Shoulder Prosthesis |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cement prosthesis
21 CFR §888.3660 |
| | Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
21 CFR §888.3690 |
| Regulatory Class: | 1. ReUnion Reversible Fracture System, Class II
2. ReUnion Reverse Shoulder Arthroplasty, Class II
3. ReUnion Total Shoulder Arthroplasty, Class II |
| Product Codes: | 1. ReUnion Reversible Fracture System
KWS
HSD
2. ReUnion Reverse Shoulder Arthroplasty
KWS
3. ReUnion Total Shoulder Arthroplasty
KWS
HSD |
| | Aequalis Reverse Fracture System (K112144) |
| Additional Predicate Devices: | ReUnion Total Shoulder Arthroplasty (TSA)
System (K103835) |
9
Description:
ReUnion RSA Shoulder System (K130895) Solar ReUnion Fracture Stem (K062113) Global Unite Shoulder System (K133834)
1. ReUnion Reversible Fracture System (RFX)
The ReUnion Reversible Fracture System consists of various length and diameter stems. The stems are made from Ti-6Al-4V according to ASTM F136 and have a Ti-plasma spray and hydroxyapatite (HA) coating on the proximal end of the shaft. 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 Arthroplasty System (RSA) 2.
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, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. 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.
3. ReUnion Total Shoulder Arthroplasty (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 will be manufactured from titanium alloy according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and be offered in 7mm-17mm distal diameters in Imm increments. The cemented humeral stems will have no coating at the proximal end and offered in 6mm-15mm distal diameters in lmm increments and includes 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed
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to mate with the subject single radius humeral heads or the modular neck adapter. manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self-pressuring glenoids (SPG) will be manufactured from X3® polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm- 56mm spherical diameters in 4mm increments.
Intended Use/Indications For Use:
1. Reversible Fracture System
Indications 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 and 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, rheumatoid arthritis, or post- traumatic arthritis.
• Proximal humeral fractures and/or dislocation.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
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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 and Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral and 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
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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.
2. Reverse Shoulder Arthroplasty (RSA)
The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically and structurally 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 cuff with sever arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be
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anatomically and structurally suited to receive the implant(s).
3. Total Shoulder Arthroplasty (TSA)
Indications
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 fracture and/or dislocation.
• Clinical management problems where arthrodesis or alternative reconstructive 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.
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Bench Testing: Bench testing according to ASTM F2028. This discussion is captured in Section 020 titled "Performance Testing - Bench" Testing to determine the compatibility of the system in an MR environment was also performed. These tests included an assessment of: . Magnetically Induced Displacement Force per ASTM F2052 ● Magnetically Induced Torque per ASTM F2213 ● Heating by RF Fields per ASTM F2182 . Image Artifacts per ASTM F 2119 Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of ≤ 20EU/Device. Animal Testing: Animal testing was not required for this submission. Clinical Testing: Clinical testing was not required for this submission. Substantial Equivalence Statement: Documentation is provided which demonstrates that the ReUnion Reversible Fracture Stem, ReUnion Reverse Shoulder Arthroplasty and ReUnion Total Shoulder Arthroplasty is substantially equivalent to the predicate and reference devices in terms of its material, design, and indications for use, and performance characteristics. The documentation supports the use of ReUnion Reversible Fracture Stem (RFX) with the previously cleared RSA and TSA shoulder systems.