(145 days)
No
The document describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a shoulder arthroplasty system, indicated for relieving pain and improving function in patients with specific shoulder conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device described is a shoulder arthroplasty system (implants for joint replacement), not a device used to diagnose medical conditions. Its purpose is to treat conditions like massive and non-repairable rotator cuff tears and arthritis by replacing the shoulder joint.
No
The device description clearly states that the device is a physical component (Humeral Cup Stability and Humeral Cup 135 / 145° Stability) made of Ti-6Al-4V alloy and UHMWPE, intended to be added to existing shoulder replacement systems. It is a hardware implant, not 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 "Reversible Shoulder" system intended for "primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function." This describes a surgical implant used in vivo (within the body) to replace a joint.
- Device Description: The description details components like "Humeral Cup," "Humeral Stem," "Glenosphere," and "Glenoid Baseplate," which are all parts of a prosthetic joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
Therefore, the device described is a surgical implant, not an in vitro diagnostic device.
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 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 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 athroplasty 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 (comma separated list FDA assigned to the subject device)
PHX, HSD, KWT
Device Description
The Humeral Cup Stability and the Humeral Cup 135 / 145° Stability are components that are added to the Humelock II Reversible Shoulder System, the Humelock Reverse Shoulder and Humeris Shoulder, when used as a reverse shoulder replacement. The Humeral Cup and the Humeral Cup 135 / 145°. Mobility and Standard, were previously cleared for use in the U.S. in the Humelock II Reversible Shoulder System (K150488), and included as compatible components in the Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total shoulder construct. The 32mm Glenosphere and Cups were added to the reverse shoulder systems in K192206. These reverse total shoulder systems are used in patients with a non-functional rotator cuff and have an inverted articulation such that the ball of the articulation is on the glenoid side and the mating humeral cup is part of the humeral side of the construct, which includes either a cemented or cementless humeral stem. Depending on the humeral stem used, the humeral cup may be fixed to the humeral stem using a 135 / 145° Reverse Adapter. All mating components specific to each system are described in the respective cleared 510(k) submissions.
The predicate humeral cups, the Humeral Cup and the Humeral Cup 135 / 145°, are onepiece constructs consisting of a pre-assembled Ti-6Al-4V allov shell (ISO 5832-3) and a UHMWPE insert (ISO 5834-1 and ISO 5834-2). Both humeral cups are available in 32mm, 36mm and 40mm to articulate with the glenosphere of the same size (K150488) and come in heights of +3mm, +6mm, and +9mm.
The predicate humeral cups vary in depth providing different amounts of constraint and articulation. This submission is for the Stability variant of the Humelock Reverse Humeral Cup and 135 / 145° Humelock Reverse Humeral Cup and is a component added to the Humelock II Reversible Shoulder System (K150488), Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total 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: A comparison of the Stability variant of the Humeral Cup and the Humeral Cup 135 / 145° to the primary predicate humeral cups with respect to the designs, intended/indications for use, fundamental scientific technology of the device, material, function, manufacturing processes, shelf life, sterilization, packaging, Instructions for Use, and Surgical Technique. It is similar to the reference device. Mechanical testing to ASTM F2028-2017 and range of motion analysis in comparison to the legally marketed predicate devices demonstrates that the Stability variant of the Humeral Cup and Humeral Cup 135 / 145º is substantially equivalent and does not raise new questions of safety and effectiveness.
Clinical Testing: Not necessary to determine substantial equivalence.
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.
K150488, K162455, K163669, K192206
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
April 29, 2020
Image /page/0/Picture/1 description: The image shows 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.
FX Shoulder USA, Inc. Kathy Trier VP Regulatory, Quality, Clinical, Compliance 13465 Midway Road. Suite 101 DALLAS, Texas 75244
Re: K193394
Trade/Device Name: Humeral Cup Stability & Humeral Cup 135/145° Stability 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: March 27, 2020 Received: March 30, 2020
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 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or
1
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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Humeral Cup Stability & Humeral Cup 135 / 145° Stability
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 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 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 athroplasty 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
3
screws for 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)
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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, Quality, Clinical, Compliance |
| Date: | March 27, 2020 |
| Proprietary Name: | Humeral Cup Stability & Humeral Cup 135/145° Stability |
| Common Name: | Shoulder Prosthesis, Reverse Configuration |
| 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
(hemishoulder) metallic uncemented prosthesis – Class II
21 CFR 888.3650: shoulder joint metal/polymer
nonconstrained cemented prosthesis – Class II |
| Substantially Equivalent
Devices: | Primary Predicate:
Humelock II Reversible Shoulder System (K150488)
Humelock Reversed Shoulder System (K162455)
Humeris Shoulder System (K163669)
32mm Glenosphere and Cups (K192206)
Reference Device:
Delta Xtend™ Shoulder System (K062250). |
Device Description
The Humeral Cup Stability and the Humeral Cup 135 / 145° Stability are components that are added to the Humelock II Reversible Shoulder System, the Humelock Reverse Shoulder and Humeris Shoulder, when used as a reverse shoulder replacement. The Humeral Cup and the
5
Humeral Cup 135 / 145°. Mobility and Standard, were previously cleared for use in the U.S. in the Humelock II Reversible Shoulder System (K150488), and included as compatible components in the Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total shoulder construct. The 32mm Glenosphere and Cups were added to the reverse shoulder systems in K192206. These reverse total shoulder systems are used in patients with a non-functional rotator cuff and have an inverted articulation such that the ball of the articulation is on the glenoid side and the mating humeral cup is part of the humeral side of the construct, which includes either a cemented or cementless humeral stem. Depending on the humeral stem used, the humeral cup may be fixed to the humeral stem using a 135 / 145° Reverse Adapter. All mating components specific to each system are described in the respective cleared 510(k) submissions.
The predicate humeral cups, the Humeral Cup and the Humeral Cup 135 / 145°, are onepiece constructs consisting of a pre-assembled Ti-6Al-4V allov shell (ISO 5832-3) and a UHMWPE insert (ISO 5834-1 and ISO 5834-2). Both humeral cups are available in 32mm, 36mm and 40mm to articulate with the glenosphere of the same size (K150488) and come in heights of +3mm, +6mm, and +9mm.
The predicate humeral cups vary in depth providing different amounts of constraint and articulation. This submission is for the Stability variant of the Humelock Reverse Humeral Cup and 135 / 145° Humelock Reverse Humeral Cup and is a component added to the Humelock II Reversible Shoulder System (K150488), Humelock Reversed Shoulder System (K162455) and the Humeris Shoulder (K163669), when used for a reversed total 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 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 metadene baseblate 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
6
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.
Summary of Technologies / Substantial Equivalence
The Stability variant of the Humeral Cup and Humeral Cup 135 / 145º is identical to the primary predicate humeral cups, Mobility and Standard, in intended/indications for use, fundamental scientific technology of the device, material, function, manufacturing processes, shelf life, sterilization, packaging, Instructions for Use, and Surgical Technique. The Stability variant of the humeral cups is similar in design to the predicate humeral cups in that the only modification is in the depth of the cup. The Stability cup variant is similar in depth to the retentive cup included as the reference device. Based upon these similarities, the Stability variant of the Humeral Cup and Humeral Cup 135 / 145° is substantially equivalent to the predicates.
Non-Clinical Testing
Non-clinical evidence reviewed to demonstrate substantial equivalence includes a comparison of the Stability variant of the Humeral Cup and the Humeral Cup 135 / 145° to the primary predicate humeral cups with respect to the designs, intended/indications for use, fundamental scientific technology of the device, material, function, manufacturing processes, shelf life, sterilization, packaging, Instructions for Use, and Surgical Technique. It is similar to the reference device.
Mechanical testing to ASTM F2028-2017 and range of motion analysis in comparison to the legally marketed predicate devices demonstrates that the Stability variant of the Humeral Cup
7
and Humeral Cup 135 / 145º is substantially equivalent and does not raise new questions of safety and effectiveness.
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence of the Humeral Cup Stability 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 predicate submitted here, the Humeral Cup Stability and the Humeral Cup 135 / 145o Stability are expected to be as safe, as effective, and perform as well as the legally marketed device predicate.