(141 days)
Not Found
No
The summary describes a system of mechanical shoulder replacement components and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a system for total and hemi-shoulder replacement, indicated for treating painful and/or disabled joints resulting from conditions like osteoarthritis or rheumatoid arthritis, and improving function in patients with massive, non-repairable rotator cuff tears. These indications directly relate to improving a patient's health condition and alleviating symptoms, which is the definition of a therapeutic device.
No
The device description indicates that the Humeris Shoulder System is a set of implants used for total and hemi-shoulder replacement, not for diagnostical purposes.
No
The device description clearly outlines various physical components made of different materials (Ti-6Al-4V alloy, UHMWPE, Co-Cr-Mo alloy, Tantalum) that are implanted into the body. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Humeris Shoulder System is a collection of implants (humeral stems, heads, glenoid components, screws, etc.) designed to be surgically implanted into the human body to replace or augment the shoulder joint.
- Intended Use: The intended use is for total and hemi-shoulder replacement to treat conditions like osteoarthritis, rheumatoid arthritis, and massive rotator cuff tears. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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 (comma separated list FDA assigned to the subject device)
PHX, KWT, HSD
Device Description
The Humeris Shoulder is a system of shoulder components that can be used in either an anatomic or a reverse configuration.
The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 8-16mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating.
The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-14mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface.
Both humeral stems incorporate a female taper for attachment of compatible components. The Humeris humeral stems can be used with a straight or angled double taper connector or a centered spacer, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.
The straight and angled double taper connectors and the centered spacers have a male taper on each end and are used to connect the humeral stem to the humeral head. The straight double taper connector and three options of angled double taper connectors allow the angle of the head to be changed from 135° to 132° or 138° and the offset of the humeral head to be increased from +0 to +3 or +5 mm. The centered spacers also allow the offset of the humeral head to be increased from +0 to +3 or +5 mm. All of the double taper connectors and centered spacers are compatible with all sizes of humeral stems and humeral heads. The double taper connectors and the centered spacers are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
The humeral heads are available in diameters of 39 – 54 mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem. The humeral heads are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12.
The 2 peg cemented glenoid component is available in sizes extra small, small, medium and large and features two pegs for cemented fixation to the glenoid bone. It is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The 3 or 4 peg cemented glenoid component is also available in sizes extra small, small, medium and large. Sizes extra small and small have three fixation pegs. Sizes medium and large have four fixation pegs. The 3 or 4 peg cemented glenoid component is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. The central peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The Humeris humeral stems can also be used with a humeral cup and 135/145 adapter or a 135/145 humeral cup, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate, post extensions and standard (compression) or locking bone screws for use in a reverse shoulder configuration.
The humeral cup and the 135/145 humeral cup are available in two sizes, Ø36 and Ø40 mm. Each size is available in two versions, standard and mobility. Each version is available in three heights: +3mm, +6mm, +9mm; and is compatible with all sizes of humeral stems. A 24mm male taper allows attachment of the 135/145 cup to the humeral stem. If the humeral cup is used, it must be used with a 135/145 adaptor. Male tapers allow attachment of the humeral cup to the 135/145 adaptor and of the 135/145 adaptor to the humeral stem. The humeral cup and 135/145 humeral cup are preassembled, one-piece components manufactured from UHMWPE conforming to ISO 5834-2 and Ti-6Al-4V alloy conforming to ISO 5832-3.
The glenosphere is also available in Ø36 and Ø40 mm sizes and in centered and eccentric styles. The eccentric glenospheres are designed to be offset from the center of the glenoid baseplate. All glenospheres have a 10° tilt, meaning that the curvature of the glenosphere extends 10° beyond the equator of a hemisphere. This additional articular surface lateralizes the center of rotation to help reduce the potential for scapular notching by the humeral cup. All glenospheres mate with the glenoid baseplate via a taper lock. The glenospheres are also available with an optional central, cannulated screw. This screw can be threaded through the central post of the baseplate for additional security. The glenosphere components are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12. The glenosphere screw is manufactured from Ti-6Al-4V allov conforming to ISO 5832-3.
The glenoid baseplate has a round base with a central, cannulated post and four peripheral, threaded screw holes. The outer edges of the baseplate are tapered to lock with the glenosphere component.
The glenoid baseplate is used with 4.5mm standard or locking bone screws for added stability. The bone screws are available in lengths from 20 - 50mm in 5mm increments. Each screw allows an angulation of +/- 12° around the axial axis of the screw hole.
Optional post extensions are available to extend the central post of the baseplate and provide additional anchoring in cases with poor bone quality. The post extensions are available in 6mm and 10mm lengths. When used, the post extensions screw into the baseplate post.
The glenoid baseplate, standard and locking screws, and post extensions are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxyapatite coating.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Range of motion analysis, stem / double taper connector / humeral head construct fatigue testing in an anatomic configuration, post-fatigue disassembly testing, stress analysis of the worst case stem in a reverse configuration and pyrogenicity testing were conducted. Characterization of the Ti/HA plasma spray coating and glenoid loosening testing per ASTM F2028 were submitted in previous submissions and were referenced to support the current submission. The results of these tests indicate that the performance of the Humeris Shoulder is adequate for its intended use. Bacterial endotoxin testing was conducted.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence of the Humeris Shoulder to the predicate devices.
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.
Fx Solutions Humelock II Reversible Shoulder, K150488, Tornier Aequalis Ascend Flex Shoulder System, K122698
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Fx Solutions Ratsamy Thevenin Regulatory Affairs Ouality Manager 1663 Rue de Maiornas Viriat. 01440 FRANCE
May 17, 2017
Re: K163669
Trade/Device Name: Humeris Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWT, HSD Dated: April 14, 2017 Received: April 17, 2017
Dear Ratsamy Thevenin:
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. 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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are all the same color.
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163669
Device Name Humeris Shoulder
Indications for Use (Describe)
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.
| 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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3
| 510(k) Summary | |
|---|---|
| Prepared: | May 12, 2017 |
| Submitter: | Fx Solutions |
| 1663 Rue de Majornas | |
| Viriat, France 01440 | |
| Contact: | Ratsamy Thevenin |
| Regulatory Affairs Quality Manager | |
| +33 4 74 55 35 55 | |
| www.fxsolutions.fr | |
| Proprietary Name: | Humeris Shoulder |
| Common Name: | Anatomic and Reverse Shoulder Prosthesis |
| Classification Names: | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis; Class II | |
| 21 CFR 888.3650: Shoulder joint metal/polymer non-constrained | |
| cemented prosthesis; Class II | |
| 21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder) metallic | |
| uncemented prosthesis; Class II | |
| Product Codes: | 87/PHX, 87/KWT, 87/HSD |
| Primary Predicate Device: | Fx Solutions Humelock II Reversible Shoulder, K150488 |
| Additional Predicate Devices: | Tornier Aequalis Ascend Flex Shoulder System, K122698 |
Device Description:
The Humeris Shoulder is a system of shoulder components that can be used in either an anatomic or a reverse configuration.
The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 8-16mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating.
4
The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 and is available in diameters of 6-14mm and a length of 100mm. The distal end of the humeral stem is trapezoidal with a polished surface.
Both humeral stems incorporate a female taper for attachment of compatible components. The Humeris humeral stems can be used with a straight or angled double taper connector or a centered spacer, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomical shoulder configuration.
The straight and angled double taper connectors and the centered spacers have a male taper on each end and are used to connect the humeral stem to the humeral head. The straight double taper connector and three options of angled double taper connectors allow the angle of the head to be changed from 135° to 132° or 138° and the offset of the humeral head to be increased from +0 to +3 or +5 mm. The centered spacers also allow the offset of the humeral head to be increased from +0 to +3 or +5 mm. All of the double taper connectors and centered spacers are compatible with all sizes of humeral stems and humeral heads. The double taper connectors and the centered spacers are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3.
The humeral heads are available in diameters of 39 – 54 mm in centered and offset styles. The offset of the taper allows the head to be rotated relative to the cut surface of the humerus to provide optimal coverage of the bone. A female taper allows attachment to the double taper connector, which connects to the humeral stem. The humeral heads are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12.
The 2 peg cemented glenoid component is available in sizes extra small, small, medium and large and features two pegs for cemented fixation to the glenoid bone. It is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. Each peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The 3 or 4 peg cemented glenoid component is also available in sizes extra small, small, medium and large. Sizes extra small and small have three fixation pegs. Sizes medium and large have four fixation pegs. The 3 or 4 peg cemented glenoid component is manufactured from ultra-high molecular weight polyethylene (UHMWPE) conforming to ISO 5834-2. The central peg contains a radiopaque marker manufactured from tantalum conforming to ASTM F560.
The Humeris humeral stems can also be used with a humeral cup and 135/145 adapter or a 135/145 humeral cup, a centered or eccentric glenosphere with or without a central screw, a glenoid baseplate, post extensions and standard (compression) or locking bone screws for use in a reverse shoulder configuration.
5
The humeral cup and the 135/145 humeral cup are available in two sizes, Ø36 and Ø40 mm. Each size is available in two versions, standard and mobility. Each version is available in three heights: +3mm, +6mm, +9mm; and is compatible with all sizes of humeral stems. A 24mm male taper allows attachment of the 135/145 cup to the humeral stem. If the humeral cup is used, it must be used with a 135/145 adaptor. Male tapers allow attachment of the humeral cup to the 135/145 adaptor and of the 135/145 adaptor to the humeral stem. The humeral cup and 135/145 humeral cup are preassembled, one-piece components manufactured from UHMWPE conforming to ISO 5834-2 and Ti-6Al-4V alloy conforming to ISO 5832-3.
The glenosphere is also available in Ø36 and Ø40 mm sizes and in centered and eccentric styles. The eccentric glenospheres are designed to be offset from the center of the glenoid baseplate. All glenospheres have a 10° tilt, meaning that the curvature of the glenosphere extends 10° beyond the equator of a hemisphere. This additional articular surface lateralizes the center of rotation to help reduce the potential for scapular notching by the humeral cup. All glenospheres mate with the glenoid baseplate via a taper lock. The glenospheres are also available with an optional central, cannulated screw. This screw can be threaded through the central post of the baseplate for additional security. The glenosphere components are manufactured from wrought Co-Cr-Mo alloy conforming to ISO 5832-12. The glenosphere screw is manufactured from Ti-6Al-4V allov conforming to ISO 5832-3.
The glenoid baseplate has a round base with a central, cannulated post and four peripheral, threaded screw holes. The outer edges of the baseplate are tapered to lock with the glenosphere component.
The glenoid baseplate is used with 4.5mm standard or locking bone screws for added stability. The bone screws are available in lengths from 20 - 50mm in 5mm increments. Each screw allows an angulation of +/- 12° around the axial axis of the screw hole.
Optional post extensions are available to extend the central post of the baseplate and provide additional anchoring in cases with poor bone quality. The post extensions are available in 6mm and 10mm lengths. When used, the post extensions screw into the baseplate post.
The glenoid baseplate, standard and locking screws, and post extensions are manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3. The backside of the baseplate and the post extensions are coated with a plasma sprayed CP Titanium and Hydroxyapatite coating.
6
Intended Use / Indications:
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 Humeris Shoulder is substantially equivalent to the predicate device in regards to its intended use and indications, materials, design and sizes. Differences between the subject device systems and the predicate device systems do not raise new types of safety and effectiveness questions.
Non-Clinical Testing:
Range of motion analysis, stem / double taper connector / humeral head construct fatigue testing in an anatomic configuration, post-fatigue disassembly testing, stress analysis of the worst case stem in a reverse configuration and pyrogenicity testing were conducted. Characterization of the Ti/HA plasma spray coating and glenoid loosening testing per ASTM F2028 were submitted in previous submissions and were referenced to support the current submission. The results of these tests indicate that the performance of the Humeris Shoulder is adequate for its intended use. Bacterial endotoxin testing was conducted.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence of the Humeris Shoulder to the predicate devices.