(33 days)
No
The document describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
This device is an implantable prosthesis designed to replace shoulder joints for patients suffering from various conditions like rheumatoid arthritis, osteoarthritis, and rotator cuff tears, aiming to alleviate pain and restore function. This direct therapeutic action classifies it as a therapeutic device.
No
Explanation: The Aequalis Ascend Modular Reverse Shoulder System is an orthopedic implant for replacing shoulder joints, not a device used to identify or diagnose medical conditions.
No
The device description clearly outlines physical components (Modular Reverse Metaphysis, Modular Reverse Inserts, etc.) that are assembled in the operating room, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a shoulder prosthesis intended for surgical implantation to replace a damaged shoulder joint. It is a physical implant used within the body, not a device used to test samples outside the body.
The information provided focuses on the surgical implantation, the components of the implant, and the conditions for which it is indicated for use as a replacement joint. This aligns with the definition of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
- The Acqualis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and nonrepairable 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 Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Acqualis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal 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 Diaphyscal stem is well fixed
- The patient has a functional deltoid muscle
- The arthropathy is associated with a massive and non-repairable rotator cuff-tear.
- Noles:
- All components are single use
- The humeral stem is intended for comented or cementless use
- The glenoid implant is anchored to the bone with 4 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 Modular Reverse shoulder prosthesis is a component of semiconstrained reverse shoulder prosthesis.
The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided are:
- The Modular Reverse Metaphysis and Modular Reverse Assembly Screw
- The Modular Reverse Inserts
- An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly Screw can be used when maximum insert thickness does not achieve sufficient tension.
- When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
The present device submission corresponds to changes made to the version of the : device cleared in 510(k) K110599.
- When the Modular Reverse Spacer is implanted, the Modular Reverse Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
Primary Reverse Shoulder:
The Aequalis Ascend Modular Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw will mate with the existing; FDA cleared Torniar Aequalis Ascend Modular Anatomic Distal Stem (K102924 and K110865) which, when assembled together with the Aequalis Ascend Modular Reverse Insert, form a complete reverse prostheses. The reverse assembly must be used in association, with the onalis Reversed or Aequalis Reversed II glenoid implants (K081059).
Conversion Reverse Shoulder:
The Aequalis Ascend Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw are designed to allow the transformation of the Aequalis Assend Anatomic shoulder (K102924 and K110865) into an Aequalis Ascend Modular Reverse Shoulder without removal of the Diaphyseal Stem, if the stem is well fived during revision surgery. The Aequalis Ascend Reverse Metaphysis is a metal ... a metal ... a metal ... a designed to articulate as a reverse prosthesis with a specific polyethylene insert. The metal metaphysis is impacted onto the taper of the Diaphyseal Stem and then secured with the Ascend Modular Reverse Assembly Screw. The screw is tightened until it is firmly seated on the Reverse Metaphysis. A Reverse Spacer can be used when the maximum insert thickness does not achieve sufficient tension. Do ins these situations, after impaction of the Reverse Metaphysis on the Diaphyseal stem, the metal spacer is impacted on the taper of the Reverse Metaphysis and then secured with the Ascend Modular Reverse Spacer Assembly Screw. The screw is tightened with it is firmly seated on the Reverse Spacer. ... ... ......................................................................................................................................................................
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)
The modified Tornier Aequalis Ascend Modular Reverse Shoulder System was subjected to non-clinical testing such as fatigue and insert disassembly testing. The results of those non-clinical tests allow us to conclude that the Tornier Aequalis Ascend Modular Reverse Shoulder System described in this submission is substantially equivalent and as safe and effective as the cited 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 and Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and the well-being of the nation. The logo is surrounded 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, Incorporated Mr. Brahim Hadri Senior Regulatory Affairs Specialist 7701 France Avenue South, Suite 600 Edina, Minnesota 55435
Re: K112615
Trade/Device Name: Aequalis Ascend Modular Reverse 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, KWT, HSD Dated: September 7, 2011 Received: September 8, 2011
Dear Mr. Hadri:
This letter corrects our substantially equivalent letter of October 11, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
Page 2 - Mr. Brahim Hadri
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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): Device Name: Acqualis® Ascend™ Modular Reverse Shoulder System Indications for Use
- . The Acqualis Ascend Modular Reverse Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid nuscle and with massive and nonrepairable rotator cuff-tear with pain disabled by:
- Rheumatoid arthritis 0
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular 0 necrosis)
- Correction of functional deformity o
- Fractures of the humeral head O
- Traumatic arthritis 0
- o Revision of the devices if sufficient bone stock remains
- The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, Reverse Spacer, o and Reverse Spacer Assembly Screw are indicated for use as components of the Acqualis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal 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 Diaphyscal stem is well fixed o
- The patient has a functional deltoid muscle 0
- The arthropathy is associated with a massive and non-repairable rotator cuff-tear. O
- Noles:
- All components are single use 0
- The humeral stem is intended for comented or cementless use o
- The glenoid implant is anchored to the bone with 4 screws and is for non-cemented o fixation.
Prescription Usc ど (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 Dolice Eyaluation
Aluthenl. Ohes fn MyM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112615
Special 510(k) Submission: Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System
Page 11 of 79
3
SECTION 5
OCT 1 1 2011
Special 510(k) Premarket Notification
Summary of Safety and Effectiveness information
Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
-
- Device name
Aequalis Ascend Modular Reverse Shoulder System Tradc name: Shoulder Prosthesis Common name:
- 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 Inc. 7701 France Avenue South; Suite 600 Edina, MN 55435 Registration Number: 9100540
3) Company contact
Brahim Hadri
Sr. Regulatory affairs Specialist 7701 France Avenue South, Suite 600 Edina, MN 55435 USA Telephone: 781-249-8030 Fax: 952-426-7601 Email: bhadri@tornier.com
Special 510(k) Submission Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System
4
-
- Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | KWT; KWS; HSD |
5) Legally Marketed Device to which Equivalence is Claimed:
- Tornier Aequalis Ascend Modular Reverse Shoulder System: K110599
6) Device description
�
The Aequalis Ascend Modular Reverse shoulder prosthesis is a component of semiconstrained reverse shoulder prosthesis.
The Aequalis Ascend Modular Reverse Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The components provided are:
- The Modular Reverse Metaphysis and Modular Reverse Assembly Screw .
- The Modular Reverse Inserts ●
- An optional Modular Reverse Spacer and Modular Reverse Spacer Assembly . Screw can be used when maximum insert thickness does not achieve sufficient tension.
- When the Modular Reverse Spacer is implanted, the Modular Reverse O Spacer Assembly Screw will be used in place of the Modular Reverse Assembly Screw.
The present device submission corresponds to changes made to the version of the : device cleared in 510(k) K110599.
5
Primary Reverse Shoulder:
The Aequalis Ascend Modular Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw will mate with the existing; FDA cleared Torniar Aequalis Ascend Modular Anatomic Distal Stem (K102924 and K110865) which, when assembled together with the Aequalis Ascend Modular Reverse Insert, form a complete reverse prostheses. The reverse assembly must be used in association, with the onalis Reversed or Aequalis Reversed II glenoid implants (K081059).
Conversion Reverse Shoulder:
The Aequalis Ascend Reverse Metaphysis and Aequalis Ascend Modular Reverse Assembly Screw are designed to allow the transformation of the Aequalis Assend Anatomic shoulder (K102924 and K110865) into an Aequalis Ascend Modular Reverse Shoulder without removal of the Diaphyseal Stem, if the stem is well fived during revision surgery. The Aequalis Ascend Reverse Metaphysis is a metal ... a metal ... a metal ... a designed to articulate as a reverse prosthesis with a specific polyethylene insert. The metal metaphysis is impacted onto the taper of the Diaphyseal Stem and then secured with the Ascend Modular Reverse Assembly Screw. The screw is tightened until it is firmly seated on the Reverse Metaphysis. A Reverse Spacer can be used when the maximum insert thickness does not achieve sufficient tension. Do ins these situations, after impaction of the Reverse Metaphysis on the Diaphyseal stem, the metal spacer is impacted on the taper of the Reverse Metaphysis and then secured with the Ascend Modular Reverse Spacer Assembly Screw. The screw is tightened with it is firmly seated on the Reverse Spacer. ... ... ......................................................................................................................................................................
7) Materials
- The Modular Reverse Metaphysis and Modular Reverse Spacer components are . manufactured from Titanium according to ASTM F 136 Standard Specification for Wrought Titanium - 6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- The Modular Reverse Assembly Screw and Modular Reverse Spacer Assembly Screw ● are manufactured from Cobalt Chromium Molybdenum alloy according to ASTM Fl 537 Standard Specification for Wrought Coby Sconding to ASTN Ffor Surgical Implants
- The Modular Reverse Assembly Screw and Modular Reverse Spacer Assembly Screw ● include an Ultra High Molecular Weight Polyethylene (UHMWPE) plug. The material of the screws is accordance to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants or ISO-5834-2. Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded forms
6
8) Indications for Use
- The Aequalis Ascend Modular Reverse 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 O
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and O avascular necrosis)
- Correction of functional deformity O
- Fractures of the humeral head o
- Traumatic arthritis O
- Revision of the devices if sufficient bone stock remains O
- The Reverse Metaphysis and Assembly Screw or the Reverse Metaphysis, . Reverse Spacer, and Reverse Spacer Assembly Screw are indicated for use as components of the Aequalis Ascend Modular Reverse total shoulder replacement and for transformation of the Aequalis Ascend Anatomic shoulder into a reverse shoulder prosthesis without the removal of the Diaphyseal 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 Diaphyseal stem is well fixed o
- The patient has a functional deltoid muscle O
- The arthropathy is associated with a massive and non-repairable rotator o cuff-tear.
- Notes: ●
- All components are single use o
- The humeral stem is intended for cemented or cementless use O
- The glenoid implant is anchored to the bone with 4 screws and is for nono cemented fixation.
9) Summary of technologies
The modified Tornier Aequalis Ascend Modular Reverse Shoulder System was subjected to non-clinical testing such as fatigue and insert disassembly testing. The results of those non-clinical tests allow us to conclude that the Tornier Aequalis Ascend Modular Reverse Shoulder System described in this submission is substantially equivalent and as safe and effective as the cited predicate device.
Special 510(k) Submission Tornier Inc. Aequalis Ascend Modular Reverse Shoulder System