(265 days)
No
The document describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is an anatomical shoulder prosthesis used for total shoulder replacement to treat a severely painful and/or disabled joint resulting from osteoarthritis, which is a therapeutic purpose.
No
The device is a total shoulder replacement system designed to treat a severely painful and/or disabled joint. It is a prosthesis intended for implantation, not for diagnosing conditions.
No
The device description clearly details physical components made of materials like Ti-6AI-4V ELI alloy and UHMWPE, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a total shoulder replacement system used to treat a painful and/or disabled joint resulting from osteoarthritis. This is a surgical implant, not a diagnostic test performed on samples from the human body.
- Device Description: The description details the physical components of a shoulder prosthesis (humeral stemless, connector, humeral head, glenoid) and their materials. This aligns with a medical device for implantation, not a diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant used to replace a damaged joint, which falls under the category of a medical device, specifically a prosthetic implant.
N/A
Intended Use / Indications for Use
The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.
The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.
The patient's joint must be anatomically suited to receive the selected implants and a functional rotator cuff is necessary to use the device.
Product codes
PKC
Device Description
The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.
This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.
The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.
The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.
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:
Static testing includes lever out, pull out, and torque out testing of the Anchor base and static and dynamic testing of the humeral component of the Easytech® Anatomical Shoulder System includes construct fatique testing and post-fatigue pull off and torque out testing in accordance with ASTM F2009-00 (2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connection of Modular Prostheses. All samples reached 5,000,000 cvcles with no failure or disassociation observed. There was no significant mass loss of the specimen tapers. Fretting and corrosion analysis has also been completed to assess the taper interface for signs of fretting scars, fretting or pitting corrosion and presence of corrosion byproducts. Samples were evaluated via SEM and qualitative energy dispersive x-ray spectroscopy (EDS) analysis of any corrosion products observed. Fretting and corrosion results were compared to the literature and did not raise new questions of safety. Range of Motion analysis was also completed. Characterization of the Ti/HA plasma spray coating was submitted in previous submissions (K130759. K162455), is the same coating for the reference predicate (K163669), and is referenced to support the current submission. The results of these tests indicate that the performance of the Easytech® Anatomical Shoulder System is adequate for its intended use. Side-by-side mechanical testing vs reference predicate was completed for further characterization of the subject device.
Clinical Testing:
Study type: Retrospective study
Sample size: 141 patients implanted, 129 patients having a primary diagnosis of osteoarthritis were analyzed.
Data source: Multi-center study conducted at 5 sites in France as part of the manufacturer's postmarket surveillance.
Key results:
The percentage of subjects who met all four criteria (Adjusted Constant Score >54 and improved from baseline >10, no migration or subsidence, radiolucencies of the humeral or glenoid components and implant integrity was maintained, no revision surgery, no serious adverse device event) is 91.7% with a lower two-sided 90% confidence bound of 87.3%.
The average Month 24+ Adjusted Constant Score was 99.14 (SD 18.73) with a clinically significant improvement (p
§ 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
February 16, 2021
Image /page/0/Picture/1 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
FX Shoulder USA, Inc. Kathy Trier VP Regulatory, Quality, Clinical, Compliance 13465 Midway Road. Suite 101 Dallas. Texas 75244
Re: K201391
Trade/Device Name: Easytech® Anatomical Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PKC Dated: January 14, 2021 Received: January 15, 2021
Dear Kathy Trier:
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) K201391
Device Name Easytech® Anatomical Shoulder System
Indications for Use (Describe)
The Easytech® Anatomical Shoulder System is in total shoulder repacement to treat a severely painf il and/or disabled joint resulting from osteoarthritis.
The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glencid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.
The patient's joint must be anatomically suited to receive the selected implants and a functional rotator cuff is necessary to use the device.
| 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)
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3
| 510(k) Summary | |
|---|---|
| Applicant/Sponsor: | FX Shoulder USA, Inc. |
| 13465 Midway Road, Suite 101 | |
| Dallas, Texas 75244 | |
| Establishment Registration No: 3014128390 | |
| Manufacturer: | FX Solutions SAS |
| 1663 Rue de Majornas | |
| Viriat, France 01440 | |
| Establishment Registration No: 3009532798 | |
| Contact Person: | Kathy Trier, Ph.D. |
| VP Regulatory, Quality, Clinical and Compliance | |
| Date: | January 14, 2021 |
| Proprietary Name: | Easytech® Anatomical Shoulder System |
| Common Name: | Anatomic Shoulder Prosthesis |
| Product Code(s): | PKC |
| Classification Name: | 21 CFR 888.3660: shoulder joint metal/polymer |
| semi-constrained cemented prosthesis – Class II | |
| Substantially Equivalent | |
| Devices: | Primary Predicate: |
| Arthrex Eclipse (K183194) | |
| Reference Device: | |
| Tornier Simpliciti™ Shoulder System (K143552) | |
| Humeris® Shoulder System (K163669) |
Device Description
The Easytech® Anatomical Shoulder is an anatomical shoulder prothesis designed for use in patients with a functional rotator cuff. The Easytech® humeral stemless (Anchor base) is used with a connector, a centered or offset humeral head, and a glenoid for use in an anatomical shoulder configuration.
This system is designed to articulate with a glenoid component for total shoulder arthroplasty. Subject of this submission is the cementless, stemless Humeral Anchor base that is part of the Easytech® Anatomical Shoulder System. The compatible components to complete the system have been cleared previously in K111097, K123814, and K163669.
The Easytech® Anchor base is a stemless prosthesis. The cementless Anchor base is available in diameters of 30 to 38 mm. The Anchor base has a main central post with striaes. In the periphery of the Anchor base, five retentives striaes are positioned to
4
help with the primary fixation. The undersurface of the Anchor base, including the central post and retentive striaes, has a plasma sprayed CPTitanium and Hydroxyapatite coating without the superior surface and the female taper. The Anchor base incorporates a female taper for attachment of compatible components. This component is manufactured in Ti-6AI-4V ELI allov conforming to ISO 5832-3.
The Anchor base can be used with a straight taper connector or a centered spacer manufactured from Ti-6Al-4V ELI alloy conforming to ISO 5832-3, a centered or offset humeral head manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12 and a 2 pegs or 3 or 4 pegs cemented glenoid manufactured from ultra high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2 for use in an anatomical shoulder configuration.
Intended Use / Indications
The Easytech® Anatomical Shoulder System is indicated for use in total shoulder replacement to treat a severely painful and/or disabled joint resulting from osteoarthritis.
The humeral stemless of the Easytech® Anatomical Shoulder is intended for cementless use only. The glenoid components of the Easytech® Anatomical Shoulder System are intended for cemented use only.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional rotator cuff is necessary to use the device.
Summary of Technologies / Substantial Equivalence
The Easytech® Anatomical Shoulder System is substantially equivalent to the primary predicate in that it has the same indications, comprised of the same materials, is similar in design and sizes. Both are provided sterile for single use using gamma irradiation. The subject device, primary predicate and reference devices conform to recognized performance standards for total shoulder devices. The design differences do not affect safety or effectiveness as demonstrated via mechanical testing to characterize the device (vs reference device K143552) and clinically via the Easytech Anatomic Retrospective Cinical Study. The coating of the subject device is identical to the coating of the reference device K163669. Differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness.
Non-Clinical Testing
Static testing includes lever out, pull out, and torque out testing of the Anchor base and static and dynamic testing of the humeral component of the Easytech® Anatomical Shoulder System includes construct fatique testing and post-fatigue pull off and torque out testing in accordance with ASTM F2009-00 (2011) Standard Test Method for Determining the Axial Disassembly Force of Taper Connection of Modular Prostheses. All samples reached 5,000,000 cvcles with no failure or disassociation observed. There was no significant mass loss of the specimen tapers. Fretting and corrosion analysis has also been completed to assess the taper interface for signs of fretting scars, fretting or pitting corrosion and presence of corrosion byproducts. Samples were evaluated via SEM and qualitative energy dispersive x-ray spectroscopy (EDS) analysis of any corrosion products observed. Fretting and corrosion results were compared to the literature and did not raise new questions of safety. Range of Motion analysis was also completed. Characterization of the Ti/HA plasma spray coating was submitted in
5
previous submissions (K130759. K162455), is the same coating for the reference predicate (K163669), and is referenced to support the current submission. The results of these tests indicate that the performance of the Easytech® Anatomical Shoulder System is adequate for its intended use. Side-by-side mechanical testing vs reference predicate was completed for further characterization of the subject device.
Clinical Testing
The Easytech Anatomical Shoulder System Retrospective study was a single arm, multi-center study conducted at 5 sites in France as part of the manufacturer's postmarket surveillance for its shoulder devices. A total of 141 patients were implanted with the study device during the period January 2015 to December 2016, seven (7) patients refused to share their data and five (5) had a diagnosis other than osteoarthritis. The purpose of the retrospective study was to demonstrate safety and effectiveness of the Easytech Anatomical Shoulder System for total shoulder arthroplasty at Month 24. This data is real world evidence and reflects clinical experience with the Easytech stemless anatomic shoulder as it is used by orthopaedic surgeons who have community and clinic based practices and who implanted osteoarthritic patients who are representative of their broad patient population.
One hundred twenty-nine (129) patients having a primary diagnosis of osteoarthritis were analyzed and had an average length of follow-up of 3 years. A subject was a success at 24+ months if: the Adjusted Constant Score was >54 and improved from baseline >10, there was no migration or subsidence, radiolucencies of the humeral or glenoid components and implant integrity was maintained. Adjusted Constant Scorethey did not have revision surgery, and they did not have a serious adverse device event. Secondary objectives included range of motion, radiograph review for osteolysis,anatomic fracture and other observations, other adverse event and device survival. Patient outcomes were compared to the performance goal based upon the primary predicate device clinical trial.
The percentage of subjects who met all four criteria is 91.7% with a lower two-sided 90% confidence bound of 87.3%. As the lower bound is greater than the percentage of success observed in the performance goal of the predicate IDE (92.3% and the reference margin (10%), the null hypothesis is rejected in favor of the alternative hypothesis, that the Easytech Anatomical Shoulder System meets the performance goal and is a study clinical success.
The average Month 24+ Adjusted Constant Score was 99.14 (SD 18.73) with a clinically significant improvement (p