(115 days)
No
The description focuses on the mechanical components and materials of a shoulder implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a reverse shoulder system intended as a replacement for shoulder joints disabled by various conditions, including rheumatoid arthritis and osteoarthritis, which are therapeutic interventions.
No
The device is a modular reverse shoulder system indicated for replacing shoulder joints in patients with specific conditions. It is a prosthetic implant, not a tool for diagnosis.
No
The device description clearly outlines physical components (Metaphysis, Stem Spacers, Stems, Assembly Screw, Securitization System, glenosphere, polyethylene inserts, glenoid implants, screws, fracture inserts) that are assembled and implanted in the operating room. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a replacement for shoulder joints disabled by various conditions. This is a surgical implant used directly in the human body.
- Device Description: The description details the components of a shoulder prosthesis (metaphysis, stems, screws, etc.) which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples, while this device is implanted inside the body to replace a joint.
N/A
Intended Use / Indications for Use
The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:
- Rheumatoid arthritis with pain 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 0
- Revision of the devices if sufficient bone stock remains 0
Notes:
- All components are single use O
- The humeral stems: O
- The uncoated humeral stems are for cemented or cementless use; o
- The hydroxylapatite coated stems are for cementless use only o
- The glenoid implant is anchored to the bone with 4 screws and is for non-O cemented fixation.
Product codes
PHX, KWS, KWT, HSD
Device Description
The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder System (K100142, K081059).
The Aequalis Adjustable Reverse Shoulder system is supplied in separate, sterile packages which will be assembled in the operating room. The components provided will be:
- Metaphysis
- Stem Spacers
- Stems .
- Assembly Screw .
- Securitization System: Securitization Bracket and Screw .
Primary Reverse Shoulder:
The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis Ascend Modular Reverse Shoulder System K110599.
The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.
The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:
- Uncoated,
- Hydroxylapatite (HAP) coated, .
- HAP over titanium plasma spray (HAP/Ti PS) coated.
The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120).
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 Adjustable Reverse Shoulder System was subjected to non-clinical testing such as simulated use testing; fatigue testing; Galvanic Fretting Corrosion testing. Tornier concludes that its Aequalis Adjustable 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)
K102924, K110599, K081059, K100142, K082120
Reference Device(s)
K030941, K061439, K081059, K050316, K082120
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
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: K120739
Trade/Device Name: Aequalis Adjustable 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: June 27, 2012 Received: June 28, 2012
Dear Mr. Hadri:
This letter corrects our substantially equivalent letter of July 5, 2012.
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
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
KI20739 510(k) Number (if known):
Device Name: Aequalis Adjustable Reverse Shoulder System
Indications for Use
The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:
- Rheumatoid arthritis with pain 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 0
- Revision of the devices if sufficient bone stock remains 0
Notes:
- All components are single use O
- The humeral stems: O
- The uncoated humeral stems are for cemented or cementless use; o
- The hydroxylapatite coated stems are for cementless use only o
- The glenoid implant is anchored to the bone with 4 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)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K120739 |
- 510(k) Submission:
Tornier Inc. Aequalis Adjustable Reverse Shoulder System Page 11 of 81
3
K 120 7 3 9
SECTION 5
510(k) SUMMARY
Summary of Safety and Effectiveness information
Tornier Inc. Aequalis Adjustable Reverse Shoulder System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
-
- Device name
Trade name: Aequalis Adjustable Reverse Shoulder System Common name: Shoulder Prosthesis Classification Number/ Classification name/Product code:
- Device name
-
. 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 Telephone: 781-249-8030 952-426-7601 Fax: Email: bhadri@tornier.com
Page 12 of 81
4
-
- Classification
Device class: Classification panel: Product code:
- Classification
Class II Orthopedic KWT; KWS; HSD
5) Legally Marketed Device to which Equivalence is Claimed:
- Tornier Aequalis Ascend Modular Anatomic Shoulder, Prosthesis: K102924
- Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599
- Tornier Aequalis Reversed Shoulder Prosthesis: K081059
- Tornier Aequalis Reversed Shoulder Prosthesis (HAP Coated): K100142
- Tornier Aequalis Reversed Fracture Shoulder Prosthesis: K082120
6) Device description
The Aequalis Adjustable Reverse Shoulder system is a modular Reverse version of the Aequalis Shoulder System (K100142, K081059).
The Aequalis Adjustable Reverse Shoulder system is supplied in separate, sterile packages which will be assembled in the operating room. The components provided will be:
- Metaphysis
- Stem Spacers
- Stems .
- Assembly Screw .
- Securitization System: Securitization Bracket and Screw .
Primary Reverse Shoulder:
The Aequalis Adjustable Reverse Shoulder is a modular version of the Aequalis Reverse shoulder system. The Aequalis Adjustable Reverse Shoulder system has the same indications as Tornier Aequalis® Ascend™ Modular Reverse Shoulder System K110599.
The Aequalis Adjustable Reverse Shoulder system contains a set of anatomically sized metaphyseal, spacers, and tapered stems that will be used in conjunction with the existing Aequalis Reverse glenosphere and polyethylene inserts for reversed total shoulder arthroplasty.
Page 13 of 81
5
!
『
The device will have a series of modular stems and spacers to accommodate a varied patient population. The system will include 10 stems: Five 90mm length (9, 11, 13, 15, 17mm diameter) and five 110mm length stems with 3 options:
- Uncoated, ●
- Hydroxylapatite (HAP) coated, .
- HAP over titanium plasma spray (HAP/Ti PS) coated. ●
The Aequalis Adjustable Reverse Shoulder assembly must be used in association with the Aequalis Reversed or Aequalis Reversed II glenoid implants, screws and fracture inserts (K030941, K061439, K081059, K050316, and K082120).
7) Materials
The material used in the composition of the Aequalis Adjustable Reverse Shoulder implants is as follows:
- Humeral stems are manufactured from titanium alloy (Ti6Al4V) according to ISO � 5832-3 and are available in 3 options:
- o 1) Uncoated,
-
- Hydroxylapatite (HAP) coated according to ASTM F-1185 o
-
- HAP coated over titanium plasma spray (HAP/Ti PS) according to 0 ASTM F-1185 and ASTM F-1580
- Metaphysis components are manufactured from titanium alloy (Ti6Al4V) . according to ISO 5832-3
- Spacers are manufactured from titanium alloy (Ti6Al4V) according to ISO 5832-3 -●
- Assembly screws are manufactured from chromium cobalt alloy (CoCr) according . to ISO 5832-7
- The Secularization System Screw and Bracket are manufactured from titanium . alloy (Ti6Al4V) according to ISO 5832-3 and chromium cobalt alloy (CoCr) according to ISO 5832-7 respectively
Page 14 of 81
6
8) Indications for Use
The Aequalis Adjustable Reverse Shoulder System is indicated for patients with a functional deltoid muscle and a massive and non-repairable rotator cuff tear as a replacement of Shoulder joints disabled by:
20739
- Rheumatoid arthritis with pain O
- 0 Non-inflammatory degenerative joint disease (i.e. osteoarthritis and 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 0
Notes:
- All components are single use 0
- O The humeral stems:
- O The uncoated humeral stems are for cemented or cementless use:
- The hydroxylapatite coated stems are for cementless use only O
- O The glenoid implant is anchored to the bone with 4 screws and is for noncemented fixation.
9) Summary of technologies
In addition to the technological characteristics (material, design, sizing, indications) of the Tornier Aequalis Adjustable Reverse Shoulder System being similar or identical to the cited predicate devices; the Aequalis Adjustable Reverse Shoulder System was subjected to non-clinical testing such as simulated use testing; fatigue testing; Galvanic Fretting Corrosion testing. Tornier concludes that its Aequalis Adjustable Reverse Shoulder System described in this submission is substantially equivalent and as safe and effective as the cited predicate device.