(30 days)
Not Found
No
The summary describes a modular shoulder implant system and associated surgical instruments, with no mention of AI or ML capabilities in its design, function, or performance testing.
Yes
The device is a replacement for shoulder joints intended to reduce pain and improve shoulder mobility, which are therapeutic goals.
No
This device is a modular system for total shoulder arthroplasty, intended for replacement of shoulder joints, not for diagnosing conditions.
No
The device description explicitly states it is a "modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty," which are physical implants, not software.
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 in patients with specific conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a modular system for total shoulder arthroplasty (joint replacement). This aligns with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The Aequalis™ PerFORM™ Reversed & Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS
Device Description
The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty. The associated shoulder surgical instruments are intended to facilitate proper implantation of this shoulder system. The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is designed and indicated for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
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 bench testing and process validations were performed to demonstrate substantial equivalence of the subject device to the predicate device.
Risk analyses and device testing were performed and demonstrated that:
-
- The addition of a short Press-fit Post to the Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system meets the device testing acceptance criteria described in the predicate submission (K161742), and is substantially equivalent to predicate long Press-fit Post.
-
- Both the short and the long Press-fit Posts can be configured with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate. These configurations meet the appropriate acceptance criteria.
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
- Both the short and the long Press-fit Posts can be configured with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate. These configurations meet the appropriate 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.
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
January 30, 2019
Tornier, Inc. Moyees Kamara Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington. Minnesota 55347
Re: K183696
Trade/Device Name: Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid 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 28, 2018 Received: December 31, 2018
Dear Moyees Kamara:
We have reviewed vour 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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Vesa Vesa Vunigi -S Date: 2019.01.30 Vuniai -S 17:08:35 -05'00'
For: Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid
Indications for Use (Describe)
The Aequalis™ PerFORM™ Reversed & Aequalis™ PerFORM™+ Reversed Glenoid are indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle 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
Notes:
- · All components are single use.
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/1 description: The image features the word "TORNIER" in a bold, blue serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and has a unique design with a smaller "T" shape nested within the larger one.
Date Prepared: December 28, 2018
Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Moyees Kamara, Jr. |
| Title: | Regulatory Affairs Specialist |
| Phone: | 952.426.7637 |
| Fax: | 952.426.7601 |
| Email: | movees.kamarair@wright.com |
Device Information
| Name of Device: | Aequalis™ PerFORMTM Reversed Glenoid and Aequalis™ PerFORMTM+
Reversed Glenoid |
|-------------------|------------------------------------------------------------------------------------------|
| Common Name (s): | Shoulder Prosthesis |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR § 888.3660, Shoulder joint metal/polymer semi-constrained
cemented prosthesis. |
| Product Codes: | PHX, KWS |
Predicate Device Information
Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Predicate: Reversed Glenoid K161742 510(k) Number:
Device Description
The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is a modular system consisting of a Glenoid Component Assembly and a Humeral Component Assembly for total shoulder arthroplasty. The associated shoulder surgical instruments are intended to facilitate proper implantation of this shoulder system. The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system is designed and indicated for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
4
Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif, blue font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and is made up of two smaller hexagons.
Intended Use
The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status. The subject device and predicate device have the same intended use.
Indications for Use
The Aequalis™ PerFORM™ Reversed & Aequalis™ PerFORM™+ Reversed Glenoid are 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
Notes:
- All components are single use. ●
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
Comparison of Technological Characteristics with the Predicate Device
The proposed changes to the predicate device include the addition of a short (7 mm) Press-fit Post; use of both the short and long (15 mm) Press-fit Post lengths with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate; and the inclusion of three additional drills. The subject device has the same intended use and the fundamental scientific technology as the predicate device. The design differences do not raise new issues of safety or effectiveness and are supported by performance testing and process validations.
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.
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Image /page/5/Picture/1 description: The image shows the word "TORNIER" in large, blue, sans-serif font, followed by a blue hexagon containing a stylized letter "T". The letter "T" inside the hexagon is also in blue and has a unique design. The logo appears to be for a company named Tornier.
Performance Data
Risk analyses and device testing were performed and demonstrated that:
-
- The addition of a short Press-fit Post to the Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system meets the device testing acceptance criteria described in the predicate submission (K161742), and is substantially equivalent to predicate long Press-fit Post.
-
- Both the short and the long Press-fit Posts can be configured with the Half-Wedge Augment Baseplate and Full-Wedge Augment Baseplate. These configurations meet the appropriate acceptance criteria.
Clinical Testing
Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.
Conclusions
The Aequalis™ PerFORM™ Reversed Glenoid and Aequalis™ PerFORM™+ Reversed Glenoid shoulder system does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the subject device support substantial equivalence to the current predicate device.