(177 days)
Not Found
No
The summary describes a mechanical implant system for shoulder replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes.
The device is a total shoulder replacement system designed to relieve pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: The Inset Reverse Total Shoulder System is described as a total shoulder replacement system, which is a medical implant used for treatment (replacing a joint), not for diagnosing a condition. Its intended use focuses on pain relief and disability reduction, not on identifying or characterizing a disease.
No
The device description clearly outlines various physical components made of titanium alloy, cobalt-chromium alloy, and UHMWPE, which are implanted into the patient. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant for replacing a shoulder joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the components of a shoulder prosthesis, including stems, baseplates, spheres, and bearings, all designed for surgical implantation.
- 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) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Inset Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.
Product codes
PHX, MBF
Device Description
The Inset Reverse Total Shoulder System is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint.
For the Inset Reverse Total Shoulder System, a Glenosphere Baseplate is attached to natural bone on the glenoid side of the joint with a Central Compression Screw and Peripheral Screws. The baseplate includes a female taper to mate with the chosen Glenosphere. Glenoid baseplate components are indicated for a press-fit cement-less application with the addition of screw fixation. The chosen Humeral Bearing is attached to the Humeral Tray and the assembly is attached to the Humeral Stem (K173824) to complete the humeral side of the joint. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.
The material used in the manufacture of the humeral stem, glenoid baseplate, modular tray, compression screw, and supplementary screws are titanium alloy according to ASTM F136.
The humeral stem and the glenoid baseplate have a proximal porous coating of commercially pure titanium according to ASTM F67. The glenosphere is available in cobalt-chromium (CoCr) alloy, per ASTM F1537. The humeral bearing is manufactured from ultrahigh molecular weight polyethylene (UHMWPE) according to ASTM F648. The instruments are manufactured from stainless steel and acetal copolymer.
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 has been performed on the Inset Reverse Total Shoulder System as follows:
- Glenoid Baseplate - Glenosphere Displacement and Cyclic Fatigue Test
- Glenoid Baseplate - Glenosphere Rotational Torque Test
- Glenoid Baseplate - Glenosphere Taper Axial Strength Test
- Glenosphere Modular Connection – Fretting Corrosion Test
- Humeral Stem – Tray - Bearing Cyclic Fatigue Test
- Humeral Stem Humeral Tray Taper Strength Test
- Humeral Bearing Humeral Tray Offset Pull Out Disassembly
- Humeral Bearing - Humeral Tray Axial Disassembly
- Humeral Bearing - Humeral Tray Torque Out Disassembly
- Driving Torque Testing
- Torsional Properties Testing
- Cadaver Study
- Range of Motion Analysis
Clinical testing was not necessary to demonstrate substantial equivalence of the Inset Reverse Total Shoulder System to the predicate device.
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.
Biomet Comprehensive Reverse Shoulder (K080642), Biomet Comprehensive Reverse Shoulder Humeral Tray (K113069), Biomet Comprehensive Reverse Shoulder Mini Baseplate (K120121), Biomet Comprehensive Reverse Shoulder – Titanium Glenosphere (K131353), Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502), Biomet Comprehensive Reverse Shoulder System (K181611)
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
August 20, 2021
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" in blue, with the word "ADMINISTRATION" underneath.
Shoulder Innovations, Inc. Don Running VP R&D 13827 Port Sheldon Street Holland, Michigan 49424
Re: K210533
Trade/Device Name: Inset Reverse Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, MBF Dated: July 23, 2021 Received: July 27, 2021
Dear Don Running:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210533
Device Name Inset Reverse Total Shoulder System
Indications for Use (Describe)
The Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator ouff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Inset Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement 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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510(k) Summary
| Date Prepared: | February 15, 2021 | |
|---|---|---|
| Submitter: | Shoulder Innovations, Inc. | |
| 13827 Port Sheldon St. | ||
| Holland, MI 49424 | ||
| Contact: | Don Running | |
| Vice President – R&D | ||
| Shoulder Innovations | ||
| (574) 253-1133 | ||
| don@genesisinnovationgroup.com | ||
| Proprietary Name: | Inset Reverse Total Shoulder System | |
| Common Name: | Shoulder Prosthesis | |
| Classifications: | 21 CFR Section 888.3660 – Shoulder joint metal/polymer | |
| semi-constrained cemented prosthesis; Class II | ||
| Product Code: PHX | ||
| 21 CFR Section 888.3670 - Shoulder joint metal/polymer/ | ||
| metal nonconstrained or semi-constrained porous-coated | ||
| uncemented prosthesis; Class II | ||
| Product Code MBF | ||
| Review Panel: | Orthopedic | |
| Primary | ||
| Predicate Device: | Biomet Comprehensive Reverse Shoulder (K080642) | |
| Secondary | ||
| Predicate Devices: | Biomet Comprehensive Reverse Shoulder Humeral Tray | |
| (K113069) | ||
| Biomet Comprehensive Reverse Shoulder Mini Baseplate | ||
| (K120121) | ||
| Biomet Comprehensive Reverse Shoulder – Titanium | ||
| Glenosphere (K131353) |
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K210533 2 of 5
Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (K172502)
Biomet Comprehensive Reverse Shoulder System (K181611)
Intended Use / Indications:
The Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Inset Reverse Total Shoulder System is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.
Device Description:
The Inset Reverse Total Shoulder System is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint.
For the Inset Reverse Total Shoulder System, a Glenosphere Baseplate is attached to natural bone on the glenoid side of the joint with a Central Compression Screw and Peripheral Screws. The baseplate includes a female taper to mate with the chosen Glenosphere. Glenoid baseplate components are indicated for a press-fit cement-less application with the addition of screw fixation. The chosen Humeral Bearing is attached
5
K210533 3 of 5
to the Humeral Tray and the assembly is attached to the Humeral Stem (K173824) to complete the humeral side of the joint. Humeral stems are indicated for press-fit uncemented use or for use with bone cement.
The material used in the manufacture of the humeral stem, glenoid baseplate, modular tray, compression screw, and supplementary screws are titanium alloy according to ASTM F136.
The humeral stem and the glenoid baseplate have a proximal porous coating of commercially pure titanium according to ASTM F67. The glenosphere is available in cobalt-chromium (CoCr) alloy, per ASTM F1537. The humeral bearing is manufactured from ultrahigh molecular weight polyethylene (UHMWPE) according to ASTM F648. The instruments are manufactured from stainless steel and acetal copolymer.
Summary of Technological Characteristics and Substantial Equivalence to the Predicate Device:
The Inset Reverse Total Shoulder System is substantially equivalent to the predicate device in that both are total shoulder systems intended for a reverse configuration, both are indicated for use in primary or revision total shoulder replacement, and both are indicated for use with grossly rotator cuff deficient joints with severe arthropathy. Both the Inset Reverse Total Shoulder System and the predicate device are manufactured from Ti6Al4V alloy, CoCrMo alloy, and UHMWPE. Both the Inset Reverse Total Shoulder System and the predicate device glenoid baseplates are intended for cementless application with the addition of screw fixation. Both the Inset Reverse Total Shoulder System and the predicate device humeral stems are intended for press-fit or cement fixation.
Both the Inset Reverse Total Shoulder System and the predicate device implant components are similarly implanted; both humeral stems, press-fit or cemented, are assembled to trays with polyethylene liners that articulate with a metal glenosphere attached to a glenoid baseplate that is fixed to the glenoid with bone screws. The
6
baseplate of the predicate device is positioned off the bone when implanted, whereas the Inset Reverse Total Shoulder System Glenoid Baseplate is inset in the bone. The implant components are offered in comparable sizes.
The design differences do not raise new issues of safety or effectiveness and are supported by performance testing.
Non-Clinical Testing:
Non-clinical testing has been performed on the Inset Reverse Total Shoulder System as follows:
- . Glenoid Baseplate - Glenosphere Displacement and Cyclic Fatigue Test
- . Glenoid Baseplate - Glenosphere Rotational Torque Test
- . Glenoid Baseplate - Glenosphere Taper Axial Strength Test
- . Glenosphere Modular Connection – Fretting Corrosion Test
- . Humeral Stem – Tray - Bearing Cyclic Fatigue Test
- Humeral Stem Humeral Tray Taper Strength Test .
- Humeral Bearing Humeral Tray Offset Pull Out Disassembly .
- . Humeral Bearing - Humeral Tray Axial Disassembly
- . Humeral Bearing - Humeral Tray Torque Out Disassembly
- . Driving Torque Testing
- . Torsional Properties Testing
- . Cadaver Study
- Range of Motion Analysis .
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Inset Reverse Total Shoulder System to the predicate device.
Summary of Technologies / Substantial Equivalence:
Based on the information presented in this submission, Shoulder Innovations concludes that the Inset Reverse Total Shoulder System is substantially equivalent to the predicate
7
device in regard to indications, materials and design and does not raise new questions in regard to safety and effectiveness of the device.