A’TOMIC™ Nitinol Fixation System
Device Facts
| Record ID | K232990 |
|---|---|
| Device Name | A’TOMIC™ Nitinol Fixation System |
| Applicant | Rmr Ortho, LLC |
| Product Code | JDR · Orthopedic |
| Decision Date | Jan 12, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The A'TOMIC™ Nitinol Fixation System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The A'TOMIC Nitinol Fixation System is intended for single use only.
Device Story
Nitinol bone fixation staple system; provides compression across bone segments to enhance stability and promote fusion. Staples exhibit superelastic properties at room temperature; pre-loaded on single-use inserters. Used by surgeons in clinical settings for fracture, osteotomy, and arthrodesis. Implanted via surgical procedure; provides mechanical fixation of bone fragments. Benefits include long-term stability and fusion support. System includes various sizes and leg configurations; passivated surface oxide layer ensures biocompatibility.
Clinical Evidence
Bench testing only. Performed static four-point bend testing (ASTM F564-17), static pull-out testing (ASTM F564-17), cyclic corrosion testing (ASTM F2129-19a), and pyrogen/endotoxin testing (ANSI/AAMI ST72). Results demonstrate mechanical performance sufficient for intended use.
Technological Characteristics
Implant-grade Nitinol (ASTM F2063-18); passivated per ASTM F86. Superelastic properties at room temperature. Dimensions vary by bridge/leg length. Single-use disposable or reusable instrumentation (medical grade plastic/stainless steel). Sterile (gamma irradiation, SAL <10^-6).
Indications for Use
Indicated for fracture, osteotomy fixation, joint arthrodesis, and fixation of non-comminuted bone fragments in short, long, or flat bones. Contraindicated in patients with infection, mental/neurologic conditions preventing postoperative care, blood supply limitations, obesity, insufficient bone quality/quantity, or metal sensitivity.
Regulatory Classification
Identification
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- BME Speed™ Implant (K142292)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 12, 2024
RMR Ortho, LLC % Joe Ritz Official Correspondent 461 Private Road 4749 Castroville, Texas 78009
Re: K232990
Trade/Device Name: A'TOMICTM Nitinol Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: January 9, 2024 Received: January 9, 2024
Dear Joe Ritz:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
# Limin Sun -S
Limin Sun, Ph.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
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## Indications for Use
Submission Number (if known)
K232990
Device Name
A'TOMIC™ Nitinol Fixation System
Indications for Use (Describe)
The A'TOMIC™ Nitinol Fixation System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The A'TOMIC Nitinol Fixation System is intended for single use only.
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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Image /page/4/Picture/1 description: The image shows the logo for RMS Ortho. The logo consists of the letters "RMS" in a stylized font, with the "R" and "S" in black and the "M" in gray. Below the letters is the word "ORTHO" in a smaller font. A horizontal line extends from under the "R" to under the "S", visually connecting the letters and the word "ORTHO".
## 510(k) Summary
Date Prepared: September 21, 2023
The purpose of this submission is to seek clearance for a new device. This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
#### A. 510(k) Sponsor:
RMR Ortho, LLC 4600 Lockhill Selma Rd., Suite 107 San Antonio, TX 78249
#### B. Primary Correspondent:
Joe Ritz President joe.ritz(@blazebiotech.com
#### C. Premarket Notification:
| Trade Name: | A'TOMICTM Nitinol Fixation System |
|----------------------|-----------------------------------------------------------------------------|
| Common Name: | Staple, Fixation, Bone |
| Classification Name: | Single/Multiple component metallic bone fixation appliances and accessories |
| Regulation Number: | 21 CFR 888.3030 |
| Product Code: | JDR |
| Classification: | II |
## D. Indications for Use:
The A'TOMICTM Nitinol Fixation System is indicated for use in fracture, osteotomy fixation, and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The A TOMIC™ Nitinol Fixation System is intended for single use only.
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Image /page/5/Picture/1 description: The image shows the logo for RMS Ortho. The logo consists of the letters "RMS" in a stylized font, with the "R" and "S" in black and the "M" in gray. Below the letters is the word "ORTHO" in a smaller font, also in gray. The letters are connected by a horizontal line.
## E. Predicate Devices:
The A'TOMICTM Nitinol Fixation System implant is substantially equivalent to the following devices:
| 510(k) | Trade Name | Manufacturer |
|--------------------------|--------------------|-------------------------------------------------|
| Primary Predicate Device | | |
| K142292 | BME Speed™ Implant | BioMedical Enterprises, Inc.<br>(DePuy Synthes) |
#### F. Device Description:
The A TOMICTM Nitinol Fixation System, which consists of the A TOMIC™ Nitinol Fixation System implant and associated instruments, is intended for use for fixation and compression and supports several surgical techniques (e.g., fracture, osteotomy, joint arthrodesis, and fixation of bone fragments). The staples are made of implant-grade Nitinol (ASTM F2063-18) and are designed to exhibit superelastic properties at room temperature. This allows for continued compression to be applied across bone segments, thus enhancing long-term stability, and promoting fusion. Implants are passivated per ASTM F86 following machining to create a surface oxide layer that is resistant to corrosion which ensures the biocompatibility of the implant. Each staple is pre-loaded on an inserter for implantation and sterile packed. The staples are available in multiple sizes, varying by bridge length and leg length, to accommodate individual patient anatomy. Single-use disposable instrumentation is provided to assist in the surgical placement of the A TOMICTM Nitinol Fixation System implant. Reusable instrumentation will also be available as an option for the surgeon and facility.
| Catalog No. | Description |
|----------------|----------------------------------------------------|
| 07.20.1010.21A | A'TOMIC™ 2.0mm NITI IMPLANT 10X10mm 2-LEG, STERILE |
| 07.27.1515.21A | A'TOMIC™ 2.7mm NITI IMPLANT 15X15mm 2-LEG, STERILE |
| 07.27.1818.21A | A'TOMIC™ 2.7mm NITI IMPLANT 18X18mm 2-LEG, STERILE |
| 07.27.2118.21A | A'TOMIC™ 2.7mm NITI IMPLANT 21X18mm 2-LEG, STERILE |
| 07.27.2518.41A | A'TOMIC™ 2.7mm NITI IMPLANT 25X18mm 4-LEG, STERILE |
| 07.32.1518.21A | A'TOMIC™ 3.2mm NITI IMPLANT 15X18mm 2-LEG, STERILE |
| 07.32.1820.21A | A'TOMIC™ 3.2mm NITI IMPLANT 18X20mm 2-LEG, STERILE |
| 07.32.2120.21A | A'TOMIC™ 3.2mm NITI IMPLANT 21X20mm 2-LEG, STERILE |
| 07.32.2520.41A | A'TOMIC™ 3.2mm NITI IMPLANT 25X20mm 4-LEG, STERILE |
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Image /page/6/Picture/1 description: The image shows the logo for RMS Ortho. The logo consists of the letters "RMS" in a stylized font, with the "R" and "S" in black and the "M" in gray. Below the letters is the word "ORTHO" in a smaller font. The logo is simple and modern, and the use of black and gray gives it a professional look.
#### G. Comparison of Characteristics:
The proposed A'TOMIC™ Nitinol Fixation System implant is substantially equivalent to the predicate, BME Speed™ Implant in material, design, intended use, technological characteristics, product features, and mechanical performance.
| | Proposed<br>A'TOMIC™ Nitinol<br>Fixation System Implant | Primary<br>BME Speed™ Implant<br>(Predicate cleared under<br>K142292) | Proposed vs<br>Primary |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Product Code | JDR | JDR | Same |
| Regulation # | 888.3030 | 888.3030 | Same |
| Class | II | II | Same |
| Classification<br>Name | Staple, Fixation, Bone | Staple, Fixation, Bone | Same |
| Indications for<br>Use | The A'TOMIC™ Nitinol<br>Fixation System is indicated<br>for use in fracture, osteotomy<br>fixation and joint arthrodesis<br>as well as fixation of bone<br>fragments (i.e., small<br>fragments of bone which are<br>not comminuted to the extent<br>that precludes staple<br>placement). The device is<br>intended for use in short, long, or<br>flat bones. The<br>A'TOMIC™ Nitinol Fixation<br>System is intended for single<br>use only. | The Speed™, Speed Shift™,<br>Speed Titan™ and Speed<br>Arc™ are indicated for:<br>Fracture and osteotomy<br>fixation and joint<br>arthrodesis of the hand<br>and foot.Fixation of proximal tibial<br>metaphysis osteotomy.Hand and foot bone<br>fragments, osteotomy<br>fixation and joint<br>arthrodesis.Fixation of small<br>fragments of bone (i.e.,<br>small fragments of bone<br>which are not<br>comminuted to the extent<br>to preclude staple<br>placement). These<br>fragments may be located<br>in long bones such as the<br>femur, fibula and tibia in<br>the lower extremities; the<br>humerus, ulna or radius in<br>the upper extremities; the<br>clavicle and ribs; and in<br>flat bone such as the<br>pelvis, scapula and<br>sternum. | No significant<br>difference. |
| | Proposed<br>A'TOMICTM Nitinol<br>Fixation System Implant | Primary<br>BME Speed™ Implant<br>(Predicate cleared under<br>K142292) | Proposed vs<br>Primary |
| Contraindications | Infection Patients with mental or<br>neurologic conditions<br>who are unwilling or<br>incapable of following<br>postoperative care<br>instructions. Patient conditions<br>including blood supply<br>limitations, obesity, and<br>insufficient quantity or<br>quality of bone that<br>would impair the ability<br>to securely fix the<br>implant. Comminuted bone<br>surface that would hinder<br>staple placement. Foreign body sensitivity<br>to metals. Where material<br>sensitivity is suspected,<br>appropriate tests should<br>be made prior to<br>implantation. | Comminuted bone surface<br>that would militate<br>against staple placement Pathologic conditions of<br>bone such as osteopenia<br>that would impair the<br>ability to securely fix the<br>implant Foreign body sensitivity<br>to metals including<br>nickel. Where material<br>sensitivity is suspected,<br>appropriate tests should<br>be made prior to<br>implantation | No significant<br>difference. |
| Prescription or<br>OTC? | Prescription | Prescription | Same |
| Sterility Method | Device Provided Sterile,<br>Sterilized with Gamma<br>Irradiation | Device Provided Sterile,<br>Sterilized with Gamma<br>Irradiation | Same |
| Sterility<br>Assurance Level<br>(SAL) | <10-6 | <10-6 | Same |
| Packaging of<br>Implant Kits | Packaged with<br>inserter/retention device<br>inside a single sterile barrier<br>pouch. | Packaged with inserter inside a<br>single sterile barrier pouch | No significant<br>difference. |
| | Proposed<br>A'TOMICTM Nitinol<br>Fixation System Implant | Primary<br>BME Speed™ Implant<br>(Predicate cleared under<br>K142292) | Proposed vs<br>Primary |
| Implant Material | Nitinol | Nitinol | Same |
| Additional<br>Instruments<br>Material | Medical Grade Plastic and<br>Stainless Steel | Medical Grade Plastic and<br>Stainless Steel | No significant<br>difference. |
| Design/Physical<br>Characteristics | Natural arc on the bridge to<br>match the contour of bones,<br>round legs to match profile of<br>drill holes, barbs on legs to<br>increase pullout strength. The<br>staple is constrained in the<br>open position before release<br>into the surgical site. | Natural arc on the bridge to<br>match the contour of bones,<br>squared legs, and barbs on legs<br>to increase pullout strength.<br>The staple is constrained in the<br>open position before release<br>into the surgical site. | No significant<br>difference. |
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Image /page/7/Picture/1 description: The image shows the logo for RMS Ortho. The logo consists of the letters "RMS" in a stylized font, with the "R" and "S" in black and the "M" in gray. The word "ORTHO" is written in smaller letters below the "RMS" letters. There is a horizontal line below the letters.
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Image /page/8/Picture/1 description: The image shows a logo with the letters "RMR" in a stylized font. The letters are arranged horizontally, with the "R" on the left, the "M" in the center, and the "R" on the right. The first and last letters are black, while the middle letter is gray. Below the letters, the word "ORTHO" is written in a smaller font.
#### H. Performance Testing:
The proposed A TOMIC™ Nitinol Fixation System implant was subjected to the following mechanical performance tests to support the assertion of substantial equivalence:
- Static Four Point Bend Testing per ASTM F564-17 (FDA Recognition Number ● #11-325).
- Static Pull-out Testing per ASTM F564-17 (FDA Recognition Number #11-325). ●
- Cyclic Corrosion Testing per ASTM F2129-19a (FDA Recognition Number #8-● 522).
- Pyrogen and Endotoxins Testing per ANSI/AAMI ST72 (FDA Recognition Number #14-541).
The results of this non-clinical testing demonstrate that the mechanical performance of the A 'TOMIC™ Nitinol Fixation System implant is sufficient for its intended use and no new questions of safety or efficacy were identified during device testing; therefore, the A 'TOMIC™ Nitinol Fixation System implant is considered substantially equivalent to the BME Speed™ predicate device.
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Image /page/9/Picture/1 description: The image shows a logo with the letters "RMR" in a stylized font. The "R" on the left is black, the "M" in the middle is gray, and the "R" on the right is black. Below the letters, there is a horizontal line, and below that, the word "ORTHO" is written in a smaller, gray font. The logo appears to be for a company or organization related to orthopedics.
#### I. Conclusions:
The A TOMIC™ Nitinol Fixation System implant was shown to be substantially equivalent in performance and has the same technological characteristics as the BME Speed 11 predicate through comparison in areas including design, intended use, implant materials, product features, mechanical performance, and function. Based on the data submitted, the A'TOMIC™ Nitinol Fixation System implant does not raise any new questions about safety or efficacy. Therefore, it can be concluded that the A'TOMIC™ Nitinol Fixation System implant is substantially equivalent to the predicate device.
