(144 days)
No
The document describes a mechanical implant and its testing, with no mention of AI or ML capabilities.
Yes.
The device is a reverse shoulder prosthesis intended to replace shoulder joints for patients with specific conditions, aiming to restore functionality and alleviate pain, which are therapeutic goals.
No
Explanation: The device is a replacement shoulder joint component, not a tool for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium, including baseplates, screws, posts, and glenospheres, which are manufactured using additive manufacturing technology. This indicates a hardware medical device, not a software-only one.
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 physical implantable device (glenoid component assembly, baseplate, screws, glenosphere) designed to replace a part of the shoulder joint. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing and material properties of the implant, which are relevant for a surgical device, not an IVD.
Therefore, the Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are surgical implants, not In Vitro Diagnostic devices.
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
PHX, KWS
Device Description
The Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed Glenoid are intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed glenoid component assembly must be used in association with a Tornier humeral component:
- Humeral implants Aequalis Reversed, Aequalis Reversed Fracture or Aequalis Adjustable ● Reversed Shoulder
- . or Humeral implants Aequalis Ascend Flex Shoulder System in reverse configuration
- or humeral implants Aequalis Reversed FX2 ●
The glenoid component assembly includes a modular system including a baseplate with central screw or press-fit post, peripheral anchoring screws and a glenosphere. The baseplates are available in various design configurations including: standard, lateralized, half-wedge augment and full-wedge augment. The glenospheres are available in various design configurations including: standard, lateralized and eccentric. The press-fit post may be used with the standard baseplate in lieu of the central anchoring screw. The baseplates and the press-fit posts are manufactured using additive manufacturing technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, glenoid part of the scapulohumeral 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 performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate device.
- . Compressive Strength and Elastic Modulus Testing of Titanium Porous Metal Verification
- Titanium Porous Structure Stereological Evaluation ●
- Titanium Porous Structure Mechanical Verification
- PerFORM Reversed Fixation Pull-out Test
- Fatigue Test ●
- Range of Motion Analysis
- PerFORM Reversed Taper Pull-Off Test ●
- Glenoid Loosening Test (100,000 cycles)
- . PerFORM+ Reversed Augment Baseplate compared to the Exactech Equinoxe Reverse Augmented Baseplate Analysis
- . PerFORM Reversed Lateralization Comparison
- PerFORM Reversed and PerFORM+ Reversed Peripheral Screw Angulation ●
- Direct Metal Laser Sintering (DMLS) Process Validation
- Operational Qualification - Mechanical Validation & Microstructure Validation
- Performance Qualification - Mechanical Validation & Microstructure Validation
- . Powder Bed Position Validation
- . Powder Recycling Validation
- . Powder Removal Validation
- DMLS Device Powder Removal Cleaning ●
- DMLS Titanium Material Validation ●
- Endotoxin (
§ 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 the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right, layered on top of each other. The profiles are rendered in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
Tornier, Incorporated Ms. Laurie Lewandowski Regulatory Affairs Consultant 10801 Nesbitt Avenue South Bloomington, Minnesota 55340
Re: K161742
Trade/Device Name: Aequalis PerFORM Reversed, 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: October 14, 2016 Received: October 17, 2016
Dear Ms. Lewandowski:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Mark N. Melkerson -S
Mark 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: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161742
Device Name
Aequalis Perform Reversed 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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Image /page/3/Picture/1 description: The image shows the word "TORNIER" in a blue, sans-serif font. To the right of the word is a blue hexagon containing a stylized "T" logo. The logo consists of a "T" inside of an octagon. The overall design is clean and professional.
510(k) Summary
510(k) Number: K161742
Date Prepared: November 9, 2016
I. Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Laurie Lewandowski |
| Regulatory Affairs Consultant | |
| Phone: | 612-770-4038 |
| Fax: | 952-426-7601 |
II. Device Information
| Name of Device: | Aequalis Perform Reversed and Aequalis PerFORM+ Reversed Glenoid |
|---|---|
| Common Name: | Shoulder Prosthesis |
| Classification Name: | 21 CFR 888.3660, shoulder joint metal/polymer or semi-constrained |
| cemented prosthesis. | |
| Regulatory Class: | Class II |
| Primary Product Code: | PHX |
| Secondary Product Code: | KWS |
III. Predicate Device Information
| Primary Predicate: | Aequalis Reversed Shoulder Prosthesis, K081059 |
|---|---|
| Reference Device: | Zimmer Trabecular Metal Reverse, K052906 |
| Reference Device: | Exactech Equinoxe Reversed Augmented, K110708 |
IV. Device Description
The Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed Glenoid are intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis. Aequalis™ PerFORM Reversed and Aequalis™ PerFORM+ Reversed glenoid component assembly must be used in association with a Tornier humeral component:
- Humeral implants Aequalis Reversed, Aequalis Reversed Fracture or Aequalis Adjustable ● Reversed Shoulder
- . or Humeral implants Aequalis Ascend Flex Shoulder System in reverse configuration
- or humeral implants Aequalis Reversed FX2 ●
4
Image /page/4/Picture/1 description: The image shows the logo for Tornier. The logo consists of the word "TORNIER" in blue, followed by a blue hexagon containing a stylized "T" inside. The font of the wordmark is a serif typeface, and the overall design is clean and professional.
The glenoid component assembly includes a modular system including a baseplate with central screw or press-fit post, peripheral anchoring screws and a glenosphere. The baseplates are available in various design configurations including: standard, lateralized, half-wedge augment and full-wedge augment. The glenospheres are available in various design configurations including: standard, lateralized and eccentric. The press-fit post may be used with the standard baseplate in lieu of the central anchoring screw. The baseplates and the press-fit posts are manufactured using additive manufacturing technology.
V. Intended Use
The Aequalis PerFORM Reversed & Aequalis PerFORM+ Reversed Glenoid are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
VI. 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 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. ●
Notes:
- All components are single use.
- The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.
VII. Comparison of Technological Characteristics with the Predicate Device
The Aequalis PerFORM Reversed has the same intended use and the same fundamental scientific technology as the primary predicate and reference devices. The augment baseplates are similar to those of the reference device, Exactech Equinoxe (K110708), both of which accommodate varying glenoid bone geometry due to wear on the articular surface. The porous structure of the baseplate is similar to that of the reference device, Zimmer Trabecular Metal Reverse, K052906 Both are designed to minimize the bone reaming needed to preserved as much of the native bone as possible. The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.
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Image /page/5/Picture/1 description: The image shows the word "TORNIER" in blue, with a stylized blue logo to the right. The logo is a hexagon with a "T" inside of it. The font of the word "TORNIER" is a serif font.
VIII. Performance Data
Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate device.
- . Compressive Strength and Elastic Modulus Testing of Titanium Porous Metal Verification
- Titanium Porous Structure Stereological Evaluation ●
- Titanium Porous Structure Mechanical Verification
- PerFORM Reversed Fixation Pull-out Test
- Fatigue Test ●
- Range of Motion Analysis
- PerFORM Reversed Taper Pull-Off Test ●
- Glenoid Loosening Test (100,000 cycles)
- . PerFORM+ Reversed Augment Baseplate compared to the Exactech Equinoxe Reverse Augmented Baseplate Analysis
- . PerFORM Reversed Lateralization Comparison
- PerFORM Reversed and PerFORM+ Reversed Peripheral Screw Angulation ●
- Direct Metal Laser Sintering (DMLS) Process Validation
- Operational Qualification - Mechanical Validation & Microstructure Validation
- Performance Qualification - Mechanical Validation & Microstructure Validation
- . Powder Bed Position Validation
- . Powder Recycling Validation
- . Powder Removal Validation
- DMLS Device Powder Removal Cleaning ●
- DMLS Titanium Material Validation ●
- Endotoxin (