(126 days)
No
The 510(k) summary describes a mechanical shoulder implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing.
Yes
The device is described as a replacement for shoulder joints to provide increased mobility, stability, and relieve pain, which are therapeutic outcomes.
No
Explanation: The Aequalis Ascend Flex Shoulder System is described as a replacement for shoulder joints, indicating it is an orthopedic implant for treatment, not a device used to identify or analyze a condition.
No
The device description explicitly details 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 states that the device is a replacement of shoulder joints for various conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the components of a shoulder prosthesis (stems, heads, glenoids, adapters, screws), which are all physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
The device is a medical device used for surgical intervention to replace damaged shoulder joints.
N/A
Intended Use / Indications for 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.
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 intect or reconstructable rotator cuff, where it is intended to provide increased mobility and stability 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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, KWT, HSD
Device Description
The Aequalis Ascend Flex Shoulder System consists of:
- In a 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 UHM WPE 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joints
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)
The Aequalis Ascend Flex Shoulder System was subjected to non-clinical testing such as stem strength evaluation in Anatomic/Reverse configurations; taper evaluation; reverse adapter evaluation; head glenoids mismatch evaluation; system range of motion evaluation; and Titanium Plasma Spray coating validation per FDA guidance. The results of these nonclinical tests allow us to conclude that the Aequalis Ascend Flex Shoulder System described in this submission is substantially equivalent and as safe and effective as the predicate device.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier, SAS Mr. Brahim Hadri Senior Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K122698
Trade/Device Name: Aequalis™ Ascend™ FlexFlex Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: December 7, 2012 Received: December 10, 2012
Dear Mr. Hadri:
This letter corrects our substantially equivalent letter of January 8, 2013.
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. Iisting 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
1
Page 2 - Mr. Brahim Hadri
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (21CFR 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 yours,
Lori A. Wiggins -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
510(k) Number (if known): Aequalis™ Ascend™ FlexFlex Shoulder System Device Name:
SYSTEM 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.
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 intect or reconstructable rotator cuff, where it is intended to provide increased mobility and stability 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 .
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints IN REVERSE: for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled bv:
- 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 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 functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cufftear.
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
2013.01.03 15:20:56 -05'00'
510(k) Submission: Tornier SAS. Aequalis™ Ascend™ Flex Shoulder System
Page 10 of 124
3
K122698 1 of 4
JAN 0 8 2013
SECTION 5: 510(K) PREMARKET NOTIFICATION
Summary of Safety and Effectiveness information
Tornier Aequalis™ Ascend™ Flex Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
-
- Device name
Aequalis™ Ascend™ Flex Shoulder System Trade name: Common name: Shoulder Prosthesis
- Device name
Classification Number/ Classification name/Product code:
- · Shoulder joint metal/polymer non-constrained cemented prosthesis are class II devices under 21 CFR 888.3650 (product code KWT) and are classified by the Orthopedic Devices Panel
- · Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code KWS) and are classified by the Orthopedic Devices Panel
- · Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis are class II devices under CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel
2) Submitter
TORNIER SAS 161 rue Lavoisier 38330 Montbonnot Saint Martin- France Registration Number: 3000931034
3) Company contact
Brahim Hadri Sr. Regulatory affairs Specialist 10801 Nesbitt Avenue South Bloomington, MN 55437
Telephone: 781-249-8030 Fax: 952-426-7601 Email: bhadri@tornier.com
Page 11 of 124
4
-
- Classification
| Device class: | |
|---|---|
| Classification panel: | |
| Product code: |
Class II Orthopedic KWT; KWS; HSD;
5) Legally Marketed Device to which Equivalence is Claimed:
Primary Predicates:
- Tornier Inc. Ascend Shoulder System (K121493; most recent) .
- Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System (K112615)
Reference Predicate:
- Tornier Inc. Aequalis® Adjustable Reverse Shoulder System (K120739) .
6} Device description
The Aequalis Ascend Flex Shoulder System consists of:
- In a 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 UHM WPE 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.
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 present device submission corresponds to modifications made to the version of the device cleared in 510(k) K121493 (most recent) and K112615.
Page 12 of 124
5
3.84
7) Intended and Indications for Use
SYSTEM 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.
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 stability 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 ●
The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of IN REVERSE: 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 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.
Page 13 of 124
6
8) Summary of technologies
The Aequalis Ascend Flex Shoulder System was subjected to non-clinical testing such as stem strength evaluation in Anatomic/Reverse configurations; taper evaluation; reverse adapter evaluation; head glenoids mismatch evaluation; system range of motion evaluation; and Titanium Plasma Spray coating validation per FDA guidance. The results of these nonclinical tests allow us to conclude that the Aequalis Ascend Flex Shoulder System described in this submission is substantially equivalent and as safe and effective as the predicate device.
510(k) Submission Tornier SAS. Aequalis Ascend™ Flex Shoulder System
Page 14 of 124