(57 days)
No
The 510(k) summary describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an orthopedic implant (shoulder replacement system) intended to treat various conditions of the shoulder joint, which qualifies it as a therapeutic device.
No
Explanation: The device is an implantable medical device (shoulder system) used for joint replacement rather than for diagnosing a condition.
No
The device description clearly outlines physical components like stems, spacers, and implants, and the performance studies involve physical testing of these components. There is no mention of software as the primary or sole component.
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 disabled by various conditions. This is a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details the components of a shoulder implant (stems, spacers, glenosphere, inserts). This aligns with a surgical device, not an IVD.
- Anatomical Site: The anatomical site is the "Shoulder joints," which is a part of the human body where a surgical implant is placed, not a source of specimens for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes associated with in vitro testing.
The device is a surgical implant intended for the treatment of shoulder joint conditions.
N/A
Intended Use / Indications for Use
The Aequalis Adjustable Reversed 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
- 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
Notes:
All components are single use
The humeral stems:
- The uncoated humeral stems are for cemented or cementless use;
- The titanium plasma spray coated stems are for cemented or cementless use;
- The hydroxylapatite coated stems are for cementless use only
- The hydroxylapatite over titanium plasma spray coated stems are for cementless use only
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
Device Description
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 AscendTM 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):
The purpose of this 510(k) is to add an additional stem configuration that does not have HAP Coating and that has plasma titanium spray coating on a portion of the stem (20mm proximal portion of stem), and has a fluted surface on a portion of the stem instead of the full length of the stem (i.e., the HAP coating and fluted surface on 20mm proximal portion of stem. In addition, an alternate plasma titanium spray coating supplier has been validated to perform this manufacturing operation.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 laboratory assessment/testing was performed to evaluate the device performance per design requirements and risk analysis, including demonstration of design equivalence, fatigue testing, shear fatigue strength, static shear strength per ASTM F1044, static tensile strength per ASTM F1147, abrasion resistance per ASTM F1978, thickness per ASTM F1854, mean void intercept length per ASTM F1854, and mean volume percent of void per ASTM F1854. All testing results met pre-established acceptance criteria.
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.
K110599, K030941, K061439, K081059, K050316, K082120
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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Tornier, Incorporated Ms. Kristine Tucker Regulatory Affairs Director 10801 Nesbitt Avenue South Bloomington, Minnesota 55437
Re: K141029
Trade/Device Name: Aequalis Adjustable Reversed 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: May 22, 2014 Received: May 27, 2014
Dear Ms. Tucker:
This letter corrects our substantially equivalent letter of June 18, 2014.
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 - Ms. Kristine Tucker
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/Resourcesfor You/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) K141029
Device Name Aequalis Adjustable Reversed Shoulder System
Indications for Use (Describe)
The Aequalis Adjustable Reversed 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
- · 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
Notes:
All components are single use
The humeral stems:
- · The uncoated humeral stems are for cemented or cementless use;
- · The titanium plasma spray coated stems are for cemented or cementless use;
- · The hydroxylapatite coated stems are for cementless use only
- · The hydroxylapatite over titanium plasma spray coated stems are for cementless use only
The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Image /page/3/Picture/1 description: The image shows the word "TORNIER" in a bold, sans-serif font. To the right of the word is a hexagonal shape containing a stylized letter "T" inside. The logo appears to be a company logo or brand name.
410728717 ₪11
4 510(k) Summary
| 510(K) Owner's Name: | Tornier Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, Minnesota 55437 | |
| Phone and Fax Numbers: | Phone: 952.426.7600 |
| Cell Phone: 952.491.1451 | |
| Fax: 952.426.7601 | |
| Name of Contact Person: | Kristine Tucker |
| Date Prepared: | June 16, 2014 |
| Trade or Proprietary Name: | Tornier Aequalis Adjustable Reverse Shoulder System |
| Common or Usual Name: | Shoulder joint metal/polymer prosthesis |
| Classification Name: | 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 | |
| Legally Marketed Device to | |
| Which Your Firm Is Claiming | |
| Equivalence: | Tornier Aequalis Adjustable Reverse Shoulder System, K120739, |
| cleared on July 5, 2012. | |
| Description of The Device: | 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 AscendTM 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):
The purpose of this 510(k) is to add an additional stem
configuration that does not have HAP Coating and that has plasma
titanium spray coating on a portion of the stem (20mm proximal
portion of stem), and has a fluted surface on a portion of the stem
instead of the full length of the stem (i.e., the HAP coating and
fluted surface on 20mm proximal portion of stem. In addition, an
alternate plasma titanium spray coating supplier has been validated
to perform this manufacturing operation. |
| Intended Use of the Device: | The Aequalis Adjustable Reversed 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 |
10801 Nesbitt Avenue South
Phone: (952) 426-7600
Fax: (952) 426-7601
4
| 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 the devices if sufficient bone stock remains | |
| Notes: | |
| All components are single use | |
| The humeral stems: | |
| The uncoated humeral stems are for cemented or cementless usc; The titanium plasma spray coated stems are for cemented or cementless use; The hydroxylapatite coated stems are for cementless use only The hydroxylapatite over titanium plasma spray coated stems are for cementless use only | |
| The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation. | |
| Technological Characteristics | |
| Compared To Predicate Device: | The technological characteristics (material, design, sizing, indications, sterilization, and failure strength) of the Tornier |
| Aequalis Adjustable Reverse Shoulder System are substantially equivalent to the predicate device. | |
| Summary of the Nonclinical | |
| Tests Submitted: | Non-clinical laboratory assessment/testing was performed to evaluate the device performance per design requirements and risk analysis, including demonstration of design equivalence, fatigue testing, shear fatigue strength, static shear strength per ASTM F1044, static tensile strength per ASTM F1147, abrasion resistance per ASTM F1978, thickness per ASTM F1854, mean void intercept length per ASTM F1854, and mean volume percent of void per ASTM F1854. All testing results met pre-established acceptance criteria. |
| Conclusions Drawn From the | |
| Nonclinical and Clinical Tests: | Based on risk analysis and acceptable results from testing, the Tornier Aequalis Adjustable Reverse Shoulder System was found to be substantially equivalent to the predicate device. |
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