(103 days)
No
The document 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 or ML.
Yes.
The device is a reverse total shoulder replacement system used to address severely painful, disabling, arthritic joints, and fractures of the humeral head, and revisions of previously failed shoulder joint replacements, which are all conditions that directly relate to therapy and treatment.
No
This device is a shoulder replacement system intended for surgical implantation, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components made of titanium alloy, cobalt-chromium, and UHMWPE, which are implanted into the patient.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a Reverse Total Shoulder Prosthesis, which is an implantable device used in surgery to replace a damaged shoulder joint.
- Intended Use: The intended use is for surgical procedures to address conditions like arthritis, fractures, and failed previous shoulder replacements. This involves implanting a device into the body, not testing samples outside the body.
- Lack of IVD Characteristics: The text does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes related to disease detection or monitoring through in vitro methods.
Therefore, the INHANCE SHOULDER SYSTEM Reverse Total Shoulder is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INHANCE™ SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- A severely painful, disabling, arthritic joint
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
- Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.
Product codes
PHX, MBF, PAO
Device Description
The INHANCE REVERSE SHOULDER SYSTEM with Glenoid Peripheral Posts is intended for use in reverse total replacement procedures.
The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), peripheral posts (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).
The INHANCE REVERSE SHOULDER SYSTEM includes Peripheral Posts that are offered in 4MM, 6MM and 8MM lengths. The Peripheral Posts can be simply prepared for, and placed through, one of the peripheral holes of the Baseplate to increase contact area and aid in stability. This versatile option allows for interoperative flexibility and simple preparation to address various glenoid morphologies.
Note(s):
- When using a Peripheral Post implant, the INHANCE Reverse Shoulder System is only indicated for use with a Central Screw and Peripheral Locking Screws that are 25mm or greater in length.
- The Peripheral Post implants are only indicated for use in anterior, posterior, and superior glenoid defects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (RoM) Evaluation: An evaluation was conducted to ensure the RoM of the worst-case subject device components meet established specifications per ASTM F1378. The RoM targets were met. The subject Peripheral Posts do not represent a new worst-case component within the construct as it relates to range of motion when compared to the compatible implants cleared in K212737 (INHANCE Reverse Shoulder System).
Construct Fatigue Testing: Construct fatigue testing was performed per ASTM F1378. The acceptance criteria were met.
Construct Loosening and Disassociation: The INHANCE™ Reverse Shoulder System was evaluated for loosening and disassociation per ASTM F2028-17. The acceptance criteria were met.
Biocompatibility Assessments: A Biocompatibility Assessments was completed and provided per ISO 10993-1 and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The devices were found to be biocompatible.
Porous Structure Characterization: The porous structure used for the subject device is identical to the porous structure that was applied to the implants cleared under K202716 (INHANCE Anatomic Shoulder System) and K212737 (INHANCE Reverse Shoulder System).
MRI Compatibility: Quantitative data was obtained to inform Magnetic Resonance Imaging (MRI) Conditional Labeling through the following evaluations:
- Force: Static Magnetic Field Induced Displacement Force per ASTM F2052-15
- Torque: Static Magnetic Field Induced Torque per ASTM F2213-17
- Heating: Radiofrequency field (RF) induced heating per ASTM F2182-19e2
- Image Quality: Susceptibility induced image artifacts per ASTM F2119-07
The subject Peripheral Posts do not represent a new worst-case component within the construct as it relates to force, torque, heating, or image quality in the MR environment when compared to the compatible implants cleared in K212737 (INHANCE Reverse Shoulder System).
Shelf Life Evaluation: A shelf-life evaluation per ISO 11607-1 and ISO 11607-2 was completed on the packaging materials that make up the sterile barrier. A five-year shelf life was established based on the resultant data.
Sterilization Validation: Sterilization validation was completed using the VDmax method specified in ISO 11137-1 and ISO 11137-2. The Sterility Assurance Level (SAL) was found to be 10-6.
Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Glenoid Peripheral Posts to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
August 31, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Depuy Ireland UC % Russ Parrott VP of Research and Development Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, Indiana 46590
Re: K221467
Trade/Device Name: INHANCE™ Reverse Glenoid Peripheral Posts Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, MBF, PAO Dated: August 24, 2022 Received: August 25, 2022
Dear Russ Parrott:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
For Victoria Lilling, M.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221467
Device Name INHANCE™ Reverse Glenoid Peripheral Posts
Indications for Use (Describe)
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- · A severely painful, disabling, arthritic joint
- · Fractures of the humeral head (with Short Humeral Stems)
- · Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
- · Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw 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: | August 30, 2022 |
| Submitter: | Ignite Orthopedics LLC |
| 700 Park Ave. | |
| Suite F | |
| Winona Lake, IN 46590 | |
| Contact: | Russ Parrott |
| Chief Technology Officer | |
| Phone: 574.527.2864 | |
| russ.parrott@igniteorthopedics.com | |
| Proprietary Name: | INHANCE TM Reverse Glenoid Peripheral Posts |
| Common Name: | Reverse Shoulder Arthroplasty System |
| Classification: | Shoulder joint metal/polymer semi-constrained cemented prosthesis; (21 |
| CFR §888.3660); Class II, Pro Code PHX |
Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-
Constrained, Porous Coated, Uncemented Prosthesis (21 CFR
§888.3670); Class II, Pro Code MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive,
Cemented (21 CFR §888.3660); Class II, Pro Code PAO |
| Product Codes: | PHX, MBF, PAO |
| Predicate Devices: | K212737 (Primary) - INHANCE Reverse Shoulder System,
DePuy Ireland UC
K202611 - Catalyst OrthoScience R1 Reverse Shoulder System;
Catalyst OrthoScience, Inc. |
4
Reference Devices: K202716 - Ignite Anatomic Shoulder System; Ignite Orthopedics LLC
K183077 - Delta XTEND Reverse Shoulder System; DePuy (Ireland)
Device Description:
The INHANCE REVERSE SHOULDER SYSTEM with Glenoid Peripheral Posts is intended for use in reverse total replacement procedures.
The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), peripheral posts (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).
The INHANCE REVERSE SHOULDER SYSTEM includes Peripheral Posts that are offered in 4MM, 6MM and 8MM lengths. The Peripheral Posts can be simply prepared for, and placed through, one of the peripheral holes of the Baseplate to increase contact area and aid in stability. This versatile option allows for interoperative flexibility and simple preparation to address various glenoid morphologies.
Note(s):
- . When using a Peripheral Post implant, the INHANCE Reverse Shoulder System is only indicated for use with a Central Screw and Peripheral Locking Screws that are 25mm or greater in length.
- . The Peripheral Post implants are only indicated for use in anterior, posterior, and superior glenoid defects.
5
Intended Use / Indications for Use:
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral
stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- · A severely painful, disabling, arthritic joint
- Fractures of the humeral head (with Short Humeral Stems)
- · Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
- · Revisions of previously failed shoulder joint replacements
Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.
Summary of Technologies/Substantial Equivalence:
The subject INHANCE Reverse Glenoid Peripheral Posts has the same indications for and intended use, material, sterilization, packaging, and bearing sizes as the previously cleared INHANCE Reverse Shoulder System, K212737. The difference between the subject and predicate device is that the subject glenoid has a modular peripheral post instead of a modular peripheral screw to aid in stability. Because of these similarities, the subject of this submission, the INHANCE Reverse Glenoid Peripheral Posts, is substantially equivalent to the predicate INHANCE Reverse Shoulder System, cleared in K212737 on April 21, 2022.
The subject INHANCE Reverse Glenoid Peripheral Posts has the same indications for and intended use, materials, fixation area, fixation options, and design intent as the previously cleared Catalyst OrthoScience R1 Reverse Shoulder System, K202611. Any noted differences do not raise different questions of safety or effectiveness.
6
Non-Clinical Testing:
The INHANCE™ Reverse Shoulder System with Peripheral Posts underwent non-clinical testing and analyses using well-established methods to evaluate the change and to support a determination of substantial equivalence to the predicate device.
The following were completed:
Range of Motion (RoM) Evaluation
An evaluation was conducted to ensure the RoM of the worst-case subject device components meet established specifications per ASTM F1378. The RoM targets were met. The subject Peripheral Posts do not represent a new worst-case component within the construct as it relates to range of motion when compared to the compatible implants cleared in K212737 (INHANCE Reverse Shoulder System).
Construct Fatigue Testing
Construct fatigue testing was performed per ASTM F1378. The acceptance criteria were met.
Construct Loosening and Disassociation
The INHANCETM Reverse Shoulder System was evaluated for loosening and disassociation per ASTM F2028-17. The acceptance criteria were met.
Biocompatibility Assessments
The contact classification for the subject devices is Implant, Bone/Tissue with permanent contact (>30 days). A Biocompatibility Assessments was completed and provided per ISO 10993-1 and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The devices were found to be biocompatible. The materials and processes used in the manufacture of the Peripheral Posts and accessory instruments are identical to those used on implants and accessory instruments cleared in K212737 (INHANCE Reverse Shoulder System).
Porous Structure Characterization
The porous structure used for the subject device is identical to the porous structure that was applied to the implants cleared under K202716 (INHANCE Anatomic Shoulder System) and K212737 (INHANCE Reverse Shoulder System).
7
MRI Compatibility
Quantitative data was obtained to inform Magnetic Resonance Imaging (MRI) Conditional Labeling through the following evaluations:
- . Force: Static Magnetic Field Induced Displacement Force per ASTM F2052-15
- Torque: Static Magnetic Field Induced Torque per ASTM F2213-17 .
- Heating: Radiofrequency field (RF) induced heating per ASTM F2182-19e2 .
- Image Quality: Susceptibility induced image artifacts per ASTM F2119-07 .
The subject Peripheral Posts do not represent a new worst-case component within the construct as it relates to force, torque, heating, or image quality in the MR environment when compared to the compatible implants cleared in K212737 (INHANCE Reverse Shoulder System).
Shelf Life Evaluation
A shelf-life evaluation per ISO 11607-1 and ISO 11607-2 was completed on the packaging materials that make up the sterile barrier. A five-year shelf life was established based on the resultant data.
The subject Peripheral Posts use the same material and sterile packaging as the predicate implants cleared in K212737 (INHANCE Reverse Shoulder System) and, therefore, do not raise different questions of safety and effectiveness as it relates to shelf-life.
Sterilization Validation
Sterilization validation was completed using the VDmax method specified in ISO 11137-1 and ISO 11137-2. The Sterility Assurance Level (SAL) was found to be 10-6.
The subject Peripheral Posts use the same material, manufacturing locations, and sterile packaging as the predicate implants cleared in K212737 (INHANCE Reverse Shoulder System) and, therefore, do not raise different questions of safety and effectiveness as it relates to device sterility.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Glenoid Peripheral Posts to the predicate devices.
8
Conclusion:
A comparison of the subject and predicate devices, including comparison of the intended use, technological characteristics, and non-clinical testing results has demonstrated that the subject device is substantially equivalent to the predicate device.