(161 days)
Not Found
No
The document describes a mechanical shoulder arthroplasty system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a system for shoulder joint replacement, intended to provide increased mobility and stability, and relieve pain caused by various conditions like arthritis, fractures, and degenerative joint disease. These are therapeutic goals, aiming to treat or alleviate a medical condition.
No
The device is a shoulder arthroplasty system intended for the replacement of shoulder joints. Its purpose is therapeutic (to provide increased mobility, stability, and relieve pain), not diagnostic.
No
The device description clearly indicates it is a system of physical implants (stems, heads, couplers, inserts) for shoulder arthroplasty, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Tornier Humeral Reconstruction System and Tornier Perform Humeral System - Stem are used as replacements for shoulder joints. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description confirms that these are arthroplasty systems (joint replacement systems).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on in vitro analysis.
Therefore, the Tornier Humeral Reconstruction System and Tornier Perform Humeral System - Stem are medical devices, specifically surgical implants, and do not fall under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Tornier Humeral Reconstruction System (Tornier HRS)
IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tomier HRS is indicated for use as a replacement of shoulder joints disabled by:
- Rheumatoid arthritis with pain
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:
- Rheumatoid arthritis
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- Correction of functional deformity
- Fractures of the humeral head
- Traumatic arthritis
- Massive and non-repairable rotator cuff tear
- Revision of other devices if sufficient bone stock remains
The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notes:
- All components are single use.
- The coated humeral stem is intended for cemented or cementless use.
- The all-poly glenoid components are intended for cemented use only
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- Proximal humeral malunions
- Post-traumatic arthritis
- Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- Pseudoparalysis or anterior superior escape
- Rotator cuff tear arthropathy
- Proximal humeral malunions
- Post-traumatic arthritis
- Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
Product codes
KWS, PHX, HSD
Device Description
Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation.
The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components.
The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joints, glenohumeral articulation
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
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device.
- Fatigue testing with corrosion evaluation
- Locking mechanism fatigue testing
- Pull-out and torque-out testing
- Wear and range of motion testing
- Material characterization testing
- Biocompatibility evaluation
- Packaging and shelf-life evaluations
- Distribution testing
- Sterilization evaluation
- Endotoxin testing
- MRI compatibility evaluation
- System Compatibility Testing
No clinical studies were performed.
The Tornier HRS does not raise different guestions of safety or effectiveness in technological characteristics have been addressed with performance testing. The results of performance testing for the Tornier HRS support substantial equivalence to the predicate Aequalis Flex Revive Shoulder System (K191318, cleared on June 14, 2019).
Key Metrics
Not Found
Predicate Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 6, 2024
Stryker Corporation (Tornier, Inc.) Stefanie Tarara Principal Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K241878
Trade/Device Name: Tornier Humeral Reconstruction System (Tornier HRS): Tornier Perform Humeral System - Stem (Tornier PHS-Stem) 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: November 7, 2024 Received: November 8, 2024
Dear Stefanie Tarara:
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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph P. Russell Digitally signed by Joseph P.
-S Russell -S
Date: 2024.12.06 14:34:32 -05'00'
for: Farzana Sharmin, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Tornier Humeral Reconstruction System (Tornier HRS);
Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Indications for Use (Describe)
Tornier Humeral Reconstruction System (Tornier HRS)
IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain. The Tornier HRS is indicated for use as a replacement of shoulder joints disabled by:
- · Rheumatoid arthritis with pain
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:
- · Rheumatoid arthritis
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Massive and non-repairable rotator cuff tear
- · Revision of other devices if sufficient bone stock remains
The reversed tray and polyethylene insert are indicated for use in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notes:
- · All components are single use.
- · The coated humeral stem is intended for cemented or cementless use.
- · The all-poly glenoid components are intended for cemented use only
- · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- · Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt allov.
Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
4
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System - Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder ioints disabled by:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Proximal humeral malunions
- · Post-traumatic arthritis
· Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
The PERFORM Humeral System - Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Pseudoparalysis or anterior superior escape
- · Rotator cuff tear arthropathy
- · Proximal humeral malunions
- · Post-traumatic arthritis
· Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System - Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
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.
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
| 510(k) #: K241878 | 510(k) Summary | Prepared on: 2024-12-06 | |
|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Stryker Corporation (Tornier, Inc.) | ||
| Applicant Address | 10801 Nesbitt Avenue South Bloomington MN 55437 United States | ||
| Applicant Contact Telephone | 1-269-800-2754 | ||
| Applicant Contact | Mrs. Stefanie Tarara | ||
| Applicant Contact Email | stefanie.tarara@stryker.com | ||
| Correspondent Name | Stryker Corporation (Tornier, Inc.) | ||
| Correspondent Address | 10801 Nesbitt Avenue South Bloomington MN 55437 United States | ||
| Correspondent Contact Telephone | 1-269-800-2754 | ||
| Correspondent Contact | Mrs. Stefanie Tarara | ||
| Correspondent Contact Email | stefanie.tarara@stryker.com | ||
| Device Name | |||
| 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Tornier Humeral Reconstruction System (Tornier HRS); | ||
| Tornier Perform Humeral System - Stem (Tornier PHS-Stem) | |||
| Common Name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | ||
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis | ||
| Regulation Number | 888.3660 | ||
| Product Code(s) | KWS, PHX, HSD | ||
| Legally Marketed Predicate Devices | |||
| 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K191318 | Aequalis Flex Revive Shoulder System | KWS | |
| K201315 | Perform Humeral System - Stem (PHS-Stem) | KWS | |
| Device Description Summary | 21 CFR 807.92(a)(4) |
Tornier HRS (formerly branded Aequalis Flex Revive Shoulder System) is a fully convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier implant systems. It is a non-constrained system intended for total or partial replacement of the glenohumeral articulation.
The Tornier Humeral Reconstruction System (Tornier HRS) is a line existing Aequalis™ Flex Revive™ Shoulder System (AFR) (K191318, cleared June 14, 2019) that builds upon the AFR system with additional sized distal stems, proximal bodies, and reversed insert trays, new monoblock stems, humeral head couplers and MR Conditional labeling for Tornier HRS line extension components.
7
The Tornier Perform Humeral System (Tornier PHS-Stem) (K2013 15) is also being expanded to include additional sized Vitamin E UHMWPE reversed inserts and a renaming of these inserts for clarity.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Tornier Humeral Reconstruction System (Tornier HRS)
IN ANATOMIC:
The Tornier HRS is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Tomier HRS is indicated for use as a replacement of shoulder joints disabled by:
- · Rheumatoid arthritis with pain
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Revision of other devices if sufficient bone stock remains
IN REVERSE:
The Tornier HRS is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by:
- · Rheumatoid arthritis
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
- · Correction of functional deformity
- · Fractures of the humeral head
- · Traumatic arthritis
- · Massive and non-repairable rotator cuff tear
- · Revision of other devices if sufficient bone stock remains
The reversed tray and polyethyiene inset are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision surgery for patients with a functional deltoid muscle.
Notes:
- · All components are single use.
- · The coated humeral stem is intended for cemented or cementless use.
- · The all-poly glenoid components are intended for cemented use only
- · The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
- · Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity.
- The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
Tornier Perform Humeral System - Stem (Tornier PHS-Stem)
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Proximal humeral malunions
- · Post-traumatic arthritis
- · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intents with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is recommended for patients with a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
8
The PERFORM Humeral System – Stem is intended to be used with cemented components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System – Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
· Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Pseudoparalysis or anterior superior escape
- · Rotator cuff tear arthropathy
- · Proximal humeral malunions
- · Post-traumatic arthritis
· Revisions or fractures of the humere adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
Indications for Use Comparison
The subject device does not raise different questions of safety or effectiveness since the indications for use are identical to the predicate devices.
Technological Comparison
The Tornier HRS and the predicate Aequalis Flex Revive System have the same intended use, same principle of operation, and similar technological features. Differences for the HRS include: Even sized distal stem diameters, smaller monoblock stems, proximal body with 135 degree neck angle, humeral head couplers in three offset options, reversed tray sizes, and the addition of MR Conditional labeling.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b)
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device.
- · Fatigue testing with corrosion evaluation
- · Locking mechanism fatigue testing
- · Pull-out and torque-out testing
- · Wear and range of motion testing
- · Material characterization testing
- · Biocompatibility evaluation
- · Packaging and shelf-life evaluations
- · Distribution testing
- · Sterilization evaluation
- · Endotoxin testing
- · MRI compatibility evaluation
- · System Compatibility Testing
No clinical studies were performed.
The Tornier HRS does not raise different guestions of safety or effectiveness in technological characteristics have been addressed with performance testing. The results of performance testing for the Tornier HRS support substantial equivalence to the predicate Aequalis Flex Revive Shoulder System (K191318, cleared on June 14, 2019).
21 CFR 807.92(a)(5)
21 CER 807 92(a)(6)