(29 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a prosthesis intended to replace shoulder joints and alleviate pain, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as a replacement for shoulder joints, indicating it is an implant used in treatment, not for diagnosis.
No
The device description clearly states it is a physical implant (glenospheres made of cobalt chromium and titanium alloy) and includes ancillary instruments for implantation.
Based on the provided text, the Tornier Perform Reversed Glenospheres are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Tornier Perform Reversed Glenospheres are implants used for the replacement of shoulder joints. They are surgically implanted into the body to restore function and reduce pain.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres 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.
Product codes
PHX, KWS
Device Description
The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres are part of a reverse shoulder prosthesis consisting of cannulated cobalt chromium and titanium alloy glenospheres. The Tornier Perform Reversed Glenoid Cannulated Glenospheres are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres must be used in association with a compatible Tornier reversed glenoid and humeral component. The cannulated glenosphere can be used as part of the glenoid implant. The glenoid implant is composed of a baseplate with central and peripheral anchoring screws and a glenosphere. An optional press-fit post is available that can be used in lieu of the central anchoring screw.
Ancillary instruments are also provided for the implantation of the prosthesis.
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)
Non-clinical bench testing and process validations were performed to demonstrate substantial equivalence to the predicate device.
- Mechanical Bench Testing
- Glenosphere Loosening
- Taper Disassembly
- Glenosphere Fatigue
- Simulated Use
Biocompatibility, packaging, cleaning and sterilization for the Tornier Perform™ Reversed Glenoid Cannulated Glenospheres were also assessed in accordance with recognized consensus standards.
No clinical studies were performed.
Conclusions: The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres do 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 added Tornier Perform™ Reversed Glenoid Cannulated Glenosphere cobalt chromium and titanium alloy components support substantial equivalence to the current Aequalis PerFORM™ Reversed, Aequalis PerFORM+ Reversed Glenoid (K161742).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
October 26, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Tornier, Inc. % Lisa Stahl Principal Specialist, Regulatory Affairs 10801 Nesbitt Ave. South Bloomington, Minnesota 55437
Re: K213124
Trade/Device Name: Tornier Perform™ Reversed Glenoid Cannulated Glenospheres 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: September 24, 2021 Received: September 27, 2021
Dear Lisa Stahl:
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. 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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213124
Device Name
Tornier Perform™ Reversed Glenoid Cannulated Glenospheres
Indications for Use (Describe)
The Tornier Perform Reversed Glenospheres 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the word "TORNIER" in a blue serif font, followed by a blue hexagon containing a stylized letter "T". The font is a classic serif, with a medium weight and a clean, professional appearance. The hexagon is a geometric shape with six equal sides and angles, and the stylized "T" inside it is also blue.
Date Prepared: October 25, 2021
Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Lisa Stahl |
| Title: | Principal Specialist, Regulatory Affairs |
| Phone: | 612-849-9970 |
Device Information
| Name of Device: | Tornier Perform™ Reversed Glenoid Cannulated Glenospheres |
|---|---|
| Common Name (s): | Reverse Shoulder Prosthesis |
| Regulatory Class: | II |
| Regulation: | 21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis. | |
| Product Codes: | PHX, KWS |
Predicate Device Information
| Predicate: | Aequalis PerFORM™ Reversed, Aequalis PerFORM+ Reversed Glenoid |
|---|---|
| 510(k) Number: | K161742 |
| Reference Device: | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis |
| 510(k) Number: | K151293 |
Device Description
The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres are part of a reverse shoulder prosthesis consisting of cannulated cobalt chromium and titanium alloy glenospheres. The Tornier Perform Reversed Glenoid Cannulated Glenospheres are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.
The Tornier Perform Reversed Glenoid Cannulated Glenospheres must be used in association with a compatible Tornier reversed glenoid and humeral component. The cannulated glenosphere can be used as part of the glenoid implant. The glenoid implant is composed of a baseplate with central and peripheral anchoring screws and a glenosphere. An optional press-fit post is available that can be used in lieu of the central anchoring screw.
Ancillary instruments are also provided for the implantation of the prosthesis.
4
Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a serif font, with each letter in blue. 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 smaller hexagon inside of it.
Indications for Use
The Tornier Perform Reversed Glenoid Cannulated Glenospheres 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 ioint 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
New cannulated cobalt chromium and titanium glenospheres with the same intended use as the predicate system. The new glenospheres will be compatible with all existing components of the predicate Perform Reversed Glenoid Shoulder System. 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 to the predicate device.
- . Mechanical Bench Testing
- Glenosphere Loosening o
- Taper Disassembly O
- Glenosphere Fatigue O
- . Simulated Use
Biocompatibility, packaging, cleaning and sterilization for the Tornier Perform™ Reversed Glenoid Cannulated Glenospheres were also assessed in accordance with recognized consensus standards.
Clinical Testing
No clinical studies were performed.
Conclusions
The Tornier Perform™ Reversed Glenoid Cannulated Glenospheres do 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 added Tornier Perform™ Reversed Glenoid Cannulated Glenosphere cobalt chromium and titanium alloy components support substantial equivalence to the current Aequalis PerFORM™ Reversed, Aequalis PerFORM+ Reversed Glenoid (K161742).
Tornier Perform™ Reversed Glenoid Cannulated Glenospheres