(55 days)
No
The document describes a shoulder arthroplasty system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the mechanical aspects and compatibility of the implants.
Yes
The device, a total shoulder arthroplasty system, is indicated for the relief of pain and improvement of function in patients with chronic shoulder conditions, which are therapeutic benefits.
No
This device is a shoulder arthroplasty system, intended for surgical implantation to relieve pain and improve function in patients with specific shoulder conditions. It is a treatment device, not a diagnostic one.
No
The device description and intended use clearly describe physical implants (glenosphere, humeral cup, stems, baseplate, screws) used in surgical procedures, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes a surgical implant (shoulder prosthesis) intended to be surgically implanted into a patient's shoulder joint to relieve pain and improve function. It is a physical device used in vivo (within the body), not a test performed on a sample in vitro (outside the body).
The information provided focuses on the surgical procedure, the anatomical site, the components of the implant, and its intended use in treating specific shoulder conditions. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structuraly suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.
The Humelock Reversed Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
-
A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.
Product codes
PHX, HSD, KWT
Device Description
The 32mm Glenosphere and Humeral Cup are new components for Humelock II Reversible Shoulder System, Humelock Reversed, and Humeris Shoulder, when used for a reverse shoulder construct. Compatible components for use with the 32mm Glenosphere and Humeral Cup are the same as those previously cleared compatible components for use with the 36mm and 40mm glenospheres in the primary predicate device, K150488 Humelock II Reversible Shoulder System, K162455 Humelock Reversed Shoulder System, and K163669 Humeris Shoulder System, when used for a reverse shoulder construct.
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:
The 32mm Glenosphere and Humeral Cup are of the same design and materials as the previously cleared 36mm and 40mm glenospheres and humeral cups. Mechanical testing for the complete system was previously submitted with the cleared predicate device. Engineering analysis and range of motion analysis was also completed.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence of the 32mm Glenosphere and Humeral Cup to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Humelock II Reversible Shoulder System (K150488), Humelock Reversed Shoulder System (K162455), Humeris Shoulder System (K163669)
Reference Device(s)
DJO Surgical Reverse® Shoulder Prosthesis (RSP) (K092873)
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 8, 2019
Image /page/0/Picture/1 description: The image shows 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.
FX Shoulder USA, Inc. Kathy Trier VP Regulatory, Quality, Clinical, Compliance 13465 Midway Road, Suite 101 Dallas. Texas 75244
Re: K192206
Trade/Device Name: 32mm Glenosphere and Humeral Cup Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD, KWT Dated: August 12, 2019 Received: August 14, 2019
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
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,
Michael Owens Acting 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) K192206
Device Name 32mm Glenosphrere and Humeral Cup
Indications for Use (Describe)
The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically aud structuraly suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stems are intended for cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.
The Humelock Reversed Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.
The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
-
A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System
3
are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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7. 510(k) Summary
| Applicant/Sponsor: | FX Shoulder USA, Inc.
13465 Midway Road, Suite 101
Dallas, Texas 75244
Establishment Registration No: 3014128390 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | FX Solutions
1663 Rue de Majornas
Viriat, France 01440
Establishment Registration No: 3009532798 |
| Contact Person: | Kathy Trier, Ph.D.
VP Regulatory, Clinical, Quality, Compliance |
| Date: | August 12, 2019 |
| Proprietary Name: | 32mm Glenosphere and Humeral Cup |
| Common Name: | Reverse Shoulder Prosthesis |
| Product Code(s): | PHX, HSD, KWT |
| Classification Name: | 21 CFR 888.3660: shoulder joint metal/polymer
semi-constrained cemented prosthesis - Class II
21 CFR 888.3690 shoulder joint humeral (hemi-
shoulder) metallic uncemented prosthesis - Class II
21 CFR 888.3650: shoulder joint metal/polymer non-
constrained cemented prosthesis - Class II |
| Substantially Equivalent
Devices: | Primary Predicate:
Humelock II Reversible Shoulder System (K150488)
Humelock Reversed Shoulder System (K162455)
Humeris Shoulder System (K163669)
Reference Device:
DJO Surgical Reverse® Shoulder Prosthesis (RSP)
(K092873) |
5
Device Description
The 32mm Glenosphere and Humeral Cup are new components for Humelock II Reversible Shoulder System, Humelock Reversed, and Humeris Shoulder, when used for a reverse shoulder construct. Compatible components for use with the 32mm Glenosphere and Humeral Cup are the same as those previously cleared compatible components for use with the 36mm and 40mm glenospheres in the primary predicate device, K150488 Humelock II Reversible Shoulder System, K162455 Humelock Reversed Shoulder System, and K163669 Humeris Shoulder System, when used for a reverse shoulder construct.
Intended Use / Indications
The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structuraly suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.
The Humelock Reversed Shoulder System is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.
The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.
6
The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
-
A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
-
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).
In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.
The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.
Summary of Technologies / Substantial Equivalence
The 32mm Glenosphere and Humeral Cup are substantially equivalent to the primary predicate in that they are identical to the primary predicate on indications, design, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components, instrumentation and surgical technique. They are similar to the reference predicate in size of components and are a smaller sized components added to the product range for the primary predicate. The change, subject of this 510(k), is to add the 32mm Glenosphere and Humeral Cup to the product range. Differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness.
Non-Clinical Testing
7
The 32mm Glenosphere and Humeral Cup are of the same design and materials as the previously cleared 36mm and 40mm glenospheres and humeral cups. Mechanical testing for the complete system was previously submitted with the cleared predicate device. Engineering analysis and range of motion analysis was also completed.
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence of the 32mm Glenosphere and Humeral Cup to the predicate devices.