(245 days)
The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Revision where other devices or treatments have failed.
- · Correction of functional deformity.
- · Fracture of the humeral head
- · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.
The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).
The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.
The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.
The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.
The provided FDA 510(k) document is for the Ignite Anatomic Shoulder System, a medical device. This document describes the device itself and its equivalence to previously cleared devices. It does not contain information about an AI/ML powered device or a study involving acceptance criteria for such a device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices." This indicates that the regulatory clearance was based on non-clinical testing and comparison to predicate devices, not on a clinical study evaluating its performance against specific acceptance criteria in patient populations.
The "Non-Clinical Testing" section lists various mechanical and material-related tests (e.g., Range of Motion, Biocompatibility, Wear Testing, Fatigue Testing) conducted to demonstrate the device's substantial equivalence to predicate devices, but these are for the physical implant itself, not an AI/ML component.
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Ignite Orthopedics LLC Russ Parrott VP of Research and Development 700 Park Avenue Suite F Winona Lake, Indiana 46590
Re: K202716
Trade/Device Name: Ignite Anatomic Shoulder System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, PAO, HSD Dated: April 19, 2021 Received: April 20, 2021
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
May 20, 2021
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K202716
Device Name Ignite Anatomic Shoulder System
Indications for Use (Describe)
The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures the following:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Revision where other devices or treatments have failed.
- · Correction of functional deformity.
- · Fracture of the humeral head
· Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.
| 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 | |
|---|---|
| Prepared: | May 19, 2021 |
| Submitter: | Ignite Orthopedics LLC700 Park Ave.Suite FWinona Lake, IN 46590 |
| Contact: | Russ ParrottVP of Research and DevelopmentPhone: 574.527.2864russ.parrott@igniteorthopedics.com |
| Proprietary Nameof Subject Device: | Ignite Anatomic Shoulder System |
| Common Name: | Shoulder Arthroplasty System |
| Classification: | Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-Constrained, Porous Coated, Uncemented Prosthesis (21 CFR §888.3670); Class IIProsthesis, Shoulder, Non-Constrained, Metal/Polymer, Cemented (21 CFR §888.3650); Class IIProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Cemented (21 CER §888.3660); Class IIProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (21 CER §888.3660); Class IIProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (21 CER §888.3690); Class II |
| Product Codes: | MBF, KWT, KWS, PAO, HSD |
| SubstantiallyEquivalent PredicateDevices: | K060692 (Primary) - Comprehensive Primary Shoulder Stems, BiometManufacturing Corp. |
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K060694 - Modular Hybrid Glenoid, Biomet Manufacturing Corp.
K060716 - Versa-Dial Humeral Head Prosthesis, Biomet Manufacturing Corp.
K162024 - Altivate Anatomic Shoulder System, Encore Medical, L.P.
K111596 - Total Shoulder System, Shoulder Innovations, LLC
K091196 - Arthrosurface GRS™ Glenoid Resurfacing System, Arthrosurface, Inc.
K122698 - Aequalis Ascend Flex Shoulder System, Tornier SAS
K905786 - Global Total Shoulder, DePuy Inc.
K052472 – DePuy Global Shoulder Crosslink Glenoid, DePuy Orthopedics, Inc.
K121183 – Comprehensive Reverse Shoulder – E1 Polyethylene Claims, Biomet Manufacturing
Device Description:
The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).
The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.
The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.
The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.
Intended Use / Indications:
The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures to address the following:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. ●
- Revision where other devices or treatments have failed. ●
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- Correction of functional deformity.
- Fracture of the humeral head.
- Difficult clinical management problems, including cuff arthropathy, where other methods . of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.
Summary of Technologies:
The Ignite Anatomic Shoulder System is substantially equivalent to the predicate devices in terms of its intended use and indications, material, size ranges, and design intent. While there are minor differences, the non-clinical testing described in the next section demonstrated that the differences do not raise new types of safety and effectiveness questions.
Non-Clinical Testing:
The following performance data were provided in support of a substantial equivalence determination of the subject device:
- Range of Motion Evaluation (ASTM F1378)
- Biocompatibility Assessments (ISO 10993-1) ●
- Porous Structure Characterization (ASTM F1044, ASTM F1147, ASTM F1160, ASTM . F1978, ASTM F1854)
- Polyethylene Characterization ●
- Wear Testing (pristine and abrasive)
- Taper Pullout Testing (ASTM F2009)
- Construct Fatigue Testing ●
- Glenoid Loosening Testing (rocking horse - ASTM F2028)
- Glenoid Loosening Testing (static and cyclic torsional resistance) ●
- Glenoid Pullout Testing ●
- Shelf-Life Testing (ISO 11607-1 and ISO 11607-2) ●
- Sterilization Validation (ISO 11137-1 and ISO 11137-2)
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices.
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 devices have a safety and effectiveness profile equivalent to that of the predicate devices. Thus, the subject devices are substantially equivalent to the predicate devices.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”