(162 days)
K16742, K183696
No
The 510(k) summary describes a mechanical shoulder implant system and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the physical components and their mechanical performance.
Yes
The device is a component of shoulder arthroplasty systems intended to relieve pain and improve function, which are therapeutic outcomes.
No
The device description clearly states that these are components for a shoulder system used in total shoulder arthroplasty, which is a surgical procedure to replace a joint, not to diagnose a condition. The intended use also describes treating conditions rather than diagnosing them.
No
The device description clearly states that the device consists of physical components (Lateralized and Augmented Baseplates) for a shoulder arthroplasty system. It does not describe software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly states the device is a shoulder arthroplasty system used for surgical implantation to relieve pain and improve function in patients with specific shoulder conditions. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details components like baseplates, stems, and screws, which are parts of a surgical implant.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used in the Humelock II Reversible Shoulder System: 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 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.
When used in the Humelock Reversed Shoulder System:
The Humelock Reversed 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 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 Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cemented stems.
The clenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
When used in the Humeris Shoulder System:
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 ioint 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 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
Device Description
The Lateralized and Augmented Baseplates are new components for the Humelock II Reversible Shoulder System. They are also components added to the Humelock Reversed (K162455) and Humeris Shoulder (K163669), when used for a reverse construct. The Lateralized Baseplate can be used to increase the offset and as needed the Lateralized baseplate with augmentation has an added wedge and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.
Compatible components for use with the Lateralized and Augmented Baseplates are the same as those previously cleared compatible components for use as a component in the primary predicate devices. Humelock II Reversible K150488 and Baseplate with Screw K192799, and in the K162455 Humelock Reversed Shoulder System and K163669 Humeris Shoulder, 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
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
Non-Clinical Testing:
Previous bench testing has been submitted in the cleared 510(k) submissions for K150488 and K192799. Range of Motion analysis has been completed based upon the same parameters and assumptions as the ROM analysis previously submitted for the primary predicates and demonstrates substantial equivalence as well as exceeding ASTM F-1378-18. Glenoid loosening per ASTM F2028 met acceptance criteria and all samples ran to 100,000 cycles with no loosening of glenosphere or baseplate.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence of the Lateralized and Augmented Baseplates to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Humelock II Reversible Shoulder System (K150488), Baseplate with Screw (K192799)
Reference Device(s)
K16742, K183696
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
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.
August 25, 2021
FX Shoulder USA, Inc. Kathy Trier VP Regulatory, Quality, Clinical, Compliance 13465 Midway Road, Suite 101 Dallas, Texas 75244
Re: K210790
Trade/Device Name: Lateralized and Augmented Baseplates Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD Dated: August 4, 2021 Received: August 5, 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
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
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Indications for Use
510(k) Number (if known)
Device Name
Lateralized and Augmented Baseplates
When used in the Humelock II Reversible Shoulder System:
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 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.
When used in the Humelock Reversed Shoulder System:
The Humelock Reversed 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 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 Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cemented stems.
The clenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.
When used in the Humeris Shoulder System:
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 ioint 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 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.
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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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| 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 | |
| 574.551.1368 | |
| Date: | August 17, 2021 |
| Proprietary Name: | Lateralized and Augmented Baseplates |
| Common Name: | Reverse Shoulder Prosthesis |
| Product Code(s): | PHX, HSD |
| 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 | |
| Substantially Equivalent | |
| Devices: | Primary Predicates: |
| Humelock II Reversible Shoulder System (K150488) | |
| Baseplate with Screw (K192799) | |
| Reference Device: | |
| Aequalis PerFORM Reversed, PerFORM+ Reversed | |
| Glenoid (K16742, K183696) |
Device Description
The Lateralized and Augmented Baseplates are new components for the Humelock II Reversible Shoulder System. They are also components added to the Humelock
5
Reversed (K162455) and Humeris Shoulder (K163669), when used for a reverse construct. The Lateralized Baseplate can be used to increase the offset and as needed the Lateralized baseplate with augmentation has an added wedge and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.
Compatible components for use with the Lateralized and Augmented Baseplates are the same as those previously cleared compatible components for use as a component in the primary predicate devices. Humelock II Reversible K150488 and Baseplate with Screw K192799, and in the K162455 Humelock Reversed Shoulder System and K163669 Humeris Shoulder, when used for a reverse shoulder construct.
Intended Use / Indications
When used in the Humelock II Reversible Shoulder System: 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 ioint must be anatomically and structurally 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.
When used in the Humelock Reversed Shoulder System:
The Humelock Reversed 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 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 Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation 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.
6
When used in the Humeris Shoulder System:
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 new components, Lateralized and Augmented Baseplates, are identical to the primary predicates on indications, material, manufacturing, packaging, single use, sterilization, shelf life, biocompatibility, compatible components. The subject device is a design modification of the primary predicates. The lateralization and augmentation of the subject devices are similar to the reference device. The offset of lateralization is the same as the reference device and the augmentation of the subject device is within the degree of version correction with augmentation of the reference device. The central screw for that variant of the Baseplate options and the peripheral screws of the subject device are within the range of screws available in the reference device system. Any differences between the subject device and the primary predicate device and reference device do not raise new questions of safety and effectiveness; the FX Shoulder Lateralized and Augmented Baseplates are substantially equivalent to the primary predicate and reference device.
Non-Clinical Testing
Previous bench testing has been submitted in the cleared 510(k) submissions for K150488 and K192799. Range of Motion analysis has been completed based upon the same parameters and assumptions as the ROM analysis previously submitted for the primary predicates and demonstrates substantial equivalence as well as exceeding
7
ASTM F-1378-18. Glenoid loosening per ASTM F2028 met acceptance criteria and all samples ran to 100,000 cycles with no loosening of glenosphere or baseplate.
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence of the Lateralized and Augmented Baseplates to the predicate devices.
Summary
Based upon the assessment of substantial equivalence regarding the indications, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, and the nonclinical testing and assessment of the risk associated with the design modification of the primary predicates submitted here, the Lateralized and Augmented Baseplates are expected to be as safe, as effective, and perform as well as the legally marketed device predicates.