(116 days)
No
The document describes a mechanical shoulder implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are focused on mechanical and material properties.
Yes.
The device is a humeral implant system intended to provide increased mobility, stability, and relieve pain by replacing disabled shoulder joints due to various degenerative and traumatic conditions, explicitly stating its therapeutic purpose.
No
This device is a humeral system, an implantable prosthesis used for shoulder joint replacement, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it includes physical components such as titanium humeral stems, cobalt chrome and titanium humeral heads, and other hardware for shoulder arthroplasty.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a humeral system intended for surgical implantation as a replacement for shoulder joints. It is a physical implant used to restore function and relieve pain in patients with various shoulder conditions.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System - Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Correction of functional deformity
- Post-traumatic arthritis
- · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
The PERFORM Humeral System - Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Pseudoparalysis or anterior superior escape
- Rotator cuff tear arthropathy
- · Correction of functional deformity
- Post-traumatic arthritis
- · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System - Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
Product codes (comma separated list FDA assigned to the subject device)
PAO, KWT, KWS, HSD, PHX
Device Description
The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.
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 testing was performed to demonstrate substantial equivalence to the predicate device.
- Fatigue testing
- Static taper evaluation to ASTM F2009
- Static Reversed Insert testing
- Wear and range of motion evaluations
- Vitamin E material characterization testing
- MRI compatibility evaluation
- Biocompatibility evaluation to ISO 10993-1
- Packaging and shelf life evaluations to ISO 11607-1. ISO 11607-2, ASTM F1980
- Distribution testing to ISTA Procedure 3A, ASTM D4169, ASTM F2096
- Sterilization evaluation to ISO 11137-1 and ISO 11137-2
- Endotoxin testing to AAMI ST72
No clinical studies were performed.
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.
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2020
Tornier, Inc. Renee Stoffel Principal Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437 USA
Re: K201315
Trade/Device Name: PERFORM Humeral System - Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PAO, KWT, KWS, HSD, PHX Dated: August 7, 2020 Received: August 12, 2020
Dear Renee Stoffel:
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,
For 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) K201315
Device Name PERFORM™ Humeral System - Stem
Indications for Use (Describe)
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System - Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, and to relieve pain. The PERFORM Humeral System - Stem is indicated for use as a replacement of shoulder joints disabled by:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Correction of functional deformity
- Post-traumatic arthritis
- · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
The PERFORM Humeral System - Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
- · Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- · Pseudoparalysis or anterior superior escape
- Rotator cuff tear arthropathy
- · Correction of functional deformity
- Post-traumatic arthritis
- · Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cementless use. The PERFORM Humeral System - Stem is intended to be used with glenoid implants that are anchored to the bone with screws 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.
3
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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.
Date Prepared: August 7, 2020
Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Renee Stoffel |
| Title: | Principal Regulatory Affairs Specialist |
| Phone: | 952-683-7471 |
Device Information
| Name of Device: | PERFORM™ Humeral System – Stem |
|---|---|
| Common Name (s): | Shoulder Prosthesis |
| Regulatory Class: | II |
| Regulation: | 21 CFR 888.3650, Shoulder joint metal/polymer non-constrained cemented |
| prosthesis. | |
| 21 CFR 888.3660, Shoulder joint metal/polymer semi-constrained cemented | |
| prosthesis. | |
| 21 CFR 888.3690, Shoulder joint humeral (hemi-shoulder) metallic uncemented | |
| prosthesis. | |
| Product Codes: | KWT, KWS, HSD, PHX, PAO |
Predicate Device Information
| Predicate: | AEQUALIS ASCEND™ FLEX Shoulder System |
|---|---|
| 510(k) Number: | K190521 |
| Reference Device: | AEQUALIS™ REVERSED Shoulder System |
| 510(k) Number: | K151293 |
Device Description
The PERFORM Humeral System - Stem is an inlay convertible humeral system intended for anatomic, reverse, and hemiarthroplasty of the shoulder system also allows for conversion from an anatomic to a reverse shoulder prosthesis in the case of revision. The PERFORM Humeral System - Stem is implanted with existing Tornier glenoid systems for total anatomic and reverse shoulder arthroplasty.
The PERFORM Humeral System – Stem includes titanium humeral stems, cobalt chrome and titanium humeral heads, titanium humeral head couplers, conventional and Vitamin E UHMWPE reversed inserts, and titanium humeral spacers. The system also includes reusable instruments used to implant the shoulder prosthesis.
5
Image /page/5/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a hexagon shape, also in blue. Inside the hexagon is a stylized letter "T" with a smaller hexagon shape in the middle of the "T".
Indications for Use
In Anatomic:
The humeral stem, humeral head coupler and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with a glenoid implant, as a total replacement.
The PERFORM™ Humeral System – Stem is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility, stability, and to relieve pain. The PERFORM Humeral System – Stem is indicated for use as a replacement of shoulder joints disabled by:
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis .
- Correction of functional deformity
- Post-traumatic arthritis 0
- o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of titanium and titanium alloys are inferior to that of cobalt alloy. A titanium humeral head is not recommended for patients without a suspected material sensitivity to cobalt alloy.
All components are single use. The humeral stems are intended for cementless use.
The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
In Reverse:
The PERFORM™ Humeral System - Stem is indicated for use as a replacement of a shoulder joint for patients with a functional deltoid muscle, grossly deficient rotator cuff, and pain disabled by one or more of the following:
- o Non-inflammatory degenerative joint disease (i.e. osteoarthritis) and avascular necrosis
- Pseudoparalysis or anterior superior escape ●
- Rotator cuff tear arthropathy
- Correction of functional deformity
- Post-traumatic arthritis
- o Revisions or fractures of the humeral head where adequate fixation can be achieved and adequate bone stock remains
The reversed insert is indicated for use for the conversion from an anatomic to reverse shoulder prosthesis without the removal of a well fixed humeral stem for patients with a functional deltoid muscle.
All components are single use. The humeral stems are intended for cemented or cementless use. The PERFORM Humeral System – Stem is intended to be used with glenoid implants that are anchored to the bone with screws for non-cemented fixation.
6
Image /page/6/Picture/1 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a unique design, with a smaller "T" shape nested within the larger one.
Comparison to Predicate Device
The PERFORM Humeral System - Stem and the predicate AEQUALIS ASCEND FLEX Shoulder System have the same intended use, same principle of operation, and similar technological features. Differences for the subject PERFORM Humeral System – Stem include humeral stems with a modified connection mechanism, modular humeral heads, Vitamin E UHMWPE reverse inserts, and an optional humeral spacer instead of a required humeral tray.
Non-clinical Performance Testing
Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device.
- Fatigue testing
- Static taper evaluation to ASTM F2009 ●
- Static Reversed Insert testing
- Wear and range of motion evaluations
- Vitamin E material characterization testing
- MRI compatibility evaluation
- o Biocompatibility evaluation to ISO 10993-1
- Packaging and shelf life evaluations to ISO 11607-1. ISO 11607-2, ASTM F1980 ●
- Distribution testing to ISTA Procedure 3A, ASTM D4169, ASTM F2096 o
- Sterilization evaluation to ISO 11137-1 and ISO 11137-2 ●
- Endotoxin testing to AAMI ST72 ●
Clinical Testing
No clinical studies were performed.
Conclusions
The PERFORM™ Humeral System - Stem 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 PERFORM Humeral System - Stem support substantial equivalence to the predicate AEQUALIS ASCEND™ FLEX Shoulder System (K190521, cleared on June 12, 2019).