(100 days)
Not Found
No
The document describes a mechanical shoulder replacement 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 and is intended to relieve pain and improve mobility, which are therapeutic actions.
No
The device description clearly states "The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints". This indicates it is a prosthetic device used for treatment, not for diagnosis.
No
The device description clearly outlines physical components made of titanium, CoCr, and UHMWPE, which are hardware implants for shoulder replacement.
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 replacement for shoulder joints to relieve pain and improve mobility in patients with various conditions affecting the shoulder joint. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The device description details the components of a shoulder prosthesis (stems, heads, glenoids, adapters, screws) which are all physical implants for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
Therefore, the Aequalis Ascend Flex Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IN ANATOMIC:
The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator ouff. where it is intended to provide increased mobility and to relieve pain. The Aequalis Ascend Flex 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 Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear 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
- Revision of the devices if sufficient bone stock remains.
The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.
Notes:
- all components are single use.
- the coated humeral stem is intended for cemented or cementless use,
- the non-coated humeral stem is for cemented use only.
- 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 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.
The Aequalis Ascend Flex Shoulder System is intended for use as:
- a replacement of shoulder joints in primary anatomic or in primary reverse
- a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
Product codes (comma separated list FDA assigned to the subject device)
KWS, KWT, HSD, PHX
Device Description
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.
The Aequalis Reversed Shoulder System is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthroplasty. It is a semi-constrained system composed of a humeral and a glenoid parts.
The Aequalis Ascend Flex Shoulder System consists of:
- In an Anatomic configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
- In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter with compatible Aequalis Reversed glenoid implants. The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert. The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere: made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.
This submission corresponds to the addition of 135° & 140° reversed final angle combinations and the Inlay technique, in addition to the existing 145° angle without any change in the implants design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Testing
Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence of the subject device to the predicate device.
- Fatigue test in anatomic and reversed configuration.
Clinical Testing
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
Conclusions
The AequalisTM AscendTM Flex Shoulder System does not raise new questions of safety or effectiveness. with performance testing. The results of performance testing for the new angle combinations of the Aequalis Ascend Flex Shoulder System support substantial equivalence to the current Aequalis Ascend Flex Shoulder System (K122698, K151293).
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.
Not Found
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
June 12, 2019
Tornier SAS Lamia Askri Regulatory Affairs Specialist 161 rue Lavoisier 38330 Montbonnot Saint Martin France
Re: K190521
Trade/Device Name: Aequalis™ Ascend™ Flex Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder ioint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD, PHX Dated: May 6, 2019 Received: May 13, 2019
Dear Lamia Askri:
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
1
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 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 (QS) 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 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-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,
CAPT Raquel Peat, PhD, MPH, USPHS For: Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190521
Device Name
Aequalis Ascend Flex Shoulder System
Indications for Use (Describe)
IN ANATOMIC:
The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator ouff. where it is intended to provide increased mobility and to relieve pain. The Aequalis Ascend Flex 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 Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear 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
- Revision of the devices if sufficient bone stock remains.
The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.
Notes:
-
all components are single use.
-
the coated humeral stem is intended for cemented or cementless use,
-
the non-coated humeral stem is for cemented use only.
-
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 sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
3
patients who lack a suspected material sensitivity to cobalt alloy.
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.
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Aequalis Ascend Flex Shoulder System
Section 4 - page 3 / page 3
4
Summary of Safety and Effectiveness information Special 510(k) Premarket - Aequalis Ascend Flex Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CFR 807.92 Date Prepared: February 28,2019
Administrative Information
| Name: | Tornier SAS |
|---|---|
| Address: | 161 rue Lavoisier |
| 38330 Montbonnot Saint Martin | |
| France |
| Contact Person: | Lamia ASKRI |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Phone: | +33476613540 |
| Fax: | +33476613533 |
| Email: | lamia.askri@wright.com |
Device Information
| Name of Device: | Aequalis TM Ascend TM Flex Shoulder System |
|---|---|
| Common Name (s): | Shoulder Prosthesis |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR § 888.3660, Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis. | |
| Product Codes: | KWS, KWT, HSD, PHX |
Predicate Device Information
| Predicate: | Aequalis™ Ascend™ Flex Shoulder System |
|---|---|
| 510(k) Number: | K122698, K151293 |
Device Description:
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear.
The Aequalis Reversed Shoulder System is intended to relieve pain and significant disability following massive and non repairable cuff-tear associated to arthropathy and following massive cuff-tear arthroplasty. It is a semi-constrained system composed of a humeral and a glenoid parts.
The Aequalis Ascend Flex Shoulder System consists of:
-
- In an Anatomic configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a compatible humeral head (CoCr) with a compatible UHMWPE Aequalis glenoid; or UHMWPE Affiniti Anatomic glenoid. The Aequalis Ascend Flex Shoulder System stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid, as a total shoulder joint replacement.
-
- In a Reversed configuration: a titanium humeral stem offered in Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a reversed adapter with compatible Aequalis
5
Reversed glenoid implants. The reversed adapter is comprised of two components: a titanium tray and a UHMWPE reversed insert. The Aequalis Reversed glenoid implants is comprised of four components: Baseplate: made from Titanium; Glenoid sphere: made from of CoCr; Screw (baseplate/to glenoid sphere): made from CoCr and Fixation screws: made from Titanium.
This submission corresponds to the addition of 135° & 140° reversed final angle combinations and the Inlay technique, in addition to the existing 145° angle without any change in the implants design.
Intended Use
The Aequalis Ascend Flex Shoulder System is intended for use as:
- a replacement of shoulder joints in primary anatomic or in primary reverse
- a replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.
The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision.
Indications For Use
IN ANATOMIC:
The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.
The Aequalis Ascend Flex 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 Ascend Flex 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 Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear 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 -
- Revision of the devices if sufficient bone stock remains -
The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a
Copyright Wright Medical CORP-FORM-2698 Rev A
Section 11 - page 2 / page 5
6
functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.
Notes:
- All components are single use. -
- -The coated humeral stem is intended for cemented or cementless use.
- = The non-coated humeral stem is intended for cemented use only.
- -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.
Comparison of Technological Characteristics with the Predicate Device
The proposed changes to the predicate device include the addition of 135° & 140° reversed final angle and an alternate surgical option (Inlay), in addition to the existing 145° angle. These changes consist of added stem/ insert combinations without any change in the implants design. The subject device has the same design of implants, the same materials, the same manufacturing principle, the same method of fixation, the same packaging and the same sterilization process as the predicate device.
The new combinations do not raise new issues of safety or effectiveness and are supported by performance testing.
Non-clinical Performance Testing
Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence of the subject device to the predicate device.
- Fatigue test in anatomic and reversed configuration .
Clinical Testing
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
Conclusions
The AequalisTM Ascend™ Flex Shoulder System does not raise new questions of safety or effectiveness. with performance testing. The results of performance testing for the new angle combinations of the Aequalis Ascend Flex Shoulder System support substantial equivalence to the current Aequalis Ascend Flex Shoulder System (K122698, K151293).
Copyright Wright Medical CORP-FORM-2698 Rev A
Section 11 - page 3 / page 5