(30 days)
No
The document describes a mechanical shoulder arthroplasty system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a replacement for shoulder joints disabled by various conditions (e.g., arthritis, fractures) and is intended to provide increased mobility and relieve pain, which are therapeutic goals.
No.
Explanation: The device is a shoulder arthroplasty system intended for the replacement of shoulder joints. Its purpose is to provide increased mobility and relieve pain, not to diagnose a condition.
No
The device description clearly details physical components made of materials like Ti6A14V and CoCr, indicating it is a hardware-based implant system, not software.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The AEQUALIS™ FLEX REVIVE™ Shoulder System is described as a surgical implant used for the replacement of shoulder joints. It is a physical device implanted into the patient's body.
- Intended Use: The intended use clearly states it is for replacing shoulder joints disabled by various conditions, providing increased mobility and relieving pain. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The AEQUALIS™ FLEX REVIVE™ Shoulder System 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 AEQUALIS™ FLEX REVIVE™ Shoulder System 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 AEQUALIS™ FLEX REVIVE™ Shoulder System 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 the devices if sufficient bone stock remains
The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision 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 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 not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
Product codes (comma separated list FDA assigned to the subject device)
KWS, PHX, HSD
Device Description
AEQUALIS™ FLEX REVIVE™ Shoulder System (AFR) 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. AFR includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.
The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.
The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.
The proximal body, stem, and spacers are made from Ti6A14V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint / glenohumeral articulation
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device. These included:
- Packaging Validation Testing
- Biocompatibility Evaluation
- Press-Fit Analysis
- Simulated Use Test
The subject device passed all testing with the same acceptance criteria as the predicate device. No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 the FDA logo, which 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.
June 14, 2019
Tornier, Inc. Katie Molland, PhD, RAC Senior Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55340
Re: K191318
Trade/Device Name: AEQUALISTM FLEX REVIVE™ Shoulder System 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: May 14, 2019 Received: May 15, 2019
Dear Dr. Katie Molland:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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-regulatoryassistance/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,
For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191318
Device Name AEQUALISTM FLEX REVIVE™ Shoulder System
Indications for Use (Describe) IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The AEQUALIS™ FLEX REVIVE™ Shoulder System 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 AEQUALIS™ FLEX REVIVE™ Shoulder System 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 AEQUALIS™ FLEX REVIVE™ Shoulder System 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 the devices if sufficient bone stock remains
The reversed tray and polyethylene insert are in the conversion from an anatomic to reversed shoulder arthroplasty without the removal of the humeral assembly during revision 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 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 not recommended for patients who lack a suspected material sensitivity to cobalt alloy.
3
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)
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4
Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a hexagonal logo, also in blue, containing a stylized letter "T" within it. The logo appears to be a symbol or trademark associated with the word "TORNIER".
Date Prepared: June 12, 2019
Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Katie Molland, Ph.D. |
| Title: | Senior Regulatory Affairs Specialist |
| Phone: | 952-683-7446 |
| Fax: | 952-426-7601 |
Device Information
| Name of Device: | AEQUALIST™ FLEX REVIVE™ Shoulder System |
|---|---|
| Common Name (s): | Shoulder Prosthesis |
| Classification Name: | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 888.3660, 888.3690 |
| Product Codes: | KWS, PHX, HSD |
Predicate Device Information
AEQUALIS™ FLEX REVIVE™ Shoulder System Predicate: K181420 510(k) Number:
Reference Device Information
| Reference Device: | Biomet Comprehensive Segmental Revision System |
|---|---|
| 510(k) Number: | K173411 |
Device Description
AEQUALIS™ FLEX REVIVE™ Shoulder System (AFR) 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. AFR includes a proximal body (metaphysis), a stem, assembly screw, and locking cap. The proximal body has a female taper that is compatible with Ascend Flex Humeral Head and Ascend Flex reversed trays and poly inserts.
5
Image /page/5/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of a smaller hexagon. The logo is simple and modern, and the blue color gives it a professional look.
The AFR Shoulder System is implanted by a surgeon and is designed to allow the surgeon to select the components to size the shoulder system for the patient. It allows the shoulder to be constructed in an anatomical or reversed configuration using cleared Flex humeral heads or Ascend Flex reversed trays and inserts. In addition, the AFR Shoulder System can be transformed from anatomic to reverse shoulder prosthesis without the removal of the humeral implant assembly during revision surgery.
The humeral length is measured to determine the overall humeral implant construct length. The length is assembled from 120 mm (using the short proximal body and stem) to 300 mm (using the standard proximal body, spacers, and stem) in 10 mm increments with the spacers as needed and either of the two available lengths of the proximal body for patient specificity.
The proximal body, stem, and spacers are made from Ti6A14V per ASTM F-136. The proximal body and stem have a Titanium plasma spray coating. The assembly screw and locking cap are made of CoCr per ISO 5832-12. All implant parts are single use and packaged sterile, using gamma radiation at a minimum dose of 25 kGy to an SAL of 1x10-6.
Intended Use
The AEOUALIS™ FLEX REVIVE™ Shoulder System is intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
Indications for Use
IN ANATOMIC:
The proximal body, stem, assembly screw, locking cap, optional spacer(s), and humeral head may be used together, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The AEQUALIS™ FLEX REVIVE™ Shoulder System 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 AEQUALIS™ FLEX REVIVE™ Shoulder System 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) ●
- 0 Correction of functional deformity
- Fractures of the humeral head
- o Traumatic arthritis
Tornier, Inc.
6
Image /page/6/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of a smaller hexagon. The logo is simple and modern, and the blue color gives it a professional look.
-
Revision of other devices if sufficient bone stock remains . IN REVERSE:
The AEQUALIS™ FLEX REVIVE™ Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle with pain disabled by: -
Rheumatoid arthritis o
-
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
-
o Revision of the 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:
- o 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 o fixation.
- 0 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.
Comparison of Technological Characteristics with the Predicate Device
New Distal Stem components will be offered in additional lengths and a partially coated format for the same intended use as the predicate device. The new stems are compatible with all existing components of the predicate AFR Shoulder System. The design differences do not raise new issues of safety or effectiveness and are supported by performance testing and process validations.
7
Image /page/7/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also in blue.
Non-clinical Performance Testing
To demonstrate substantial equivalence to the predicate device, the following non-clinical bench testing and process validations were performed as indicated by risk analysis:
- Packaging Validation Testing o
- Biocompatibility Evaluation o
- Press-Fit Analysis ●
- o Simulated Use Test
The subject device passed all testing with the same acceptance criteria as the predicate device.
Clinical Testing
No clinical studies were performed.
Conclusions
The subject device is identical to the predicate device with respect to intended use, principles of operation, and conditions for use. The AEQUALIS™ FLEX REVIVE™ Shoulder System does not raise new questions of safety or effectiveness. Differences in technological characteristics that pose new potential risks as identified by risk analyses have been addressed with verification and validation testing. The results of testing for the modified AEQUALISTM FLEX REVIVE™ Shoulder System support substantial equivalence to the current AEQUALIS™ FLEX REVIVE™ Shoulder System (K181420).