(112 days)
Not Found
No
The summary describes a mechanical fixation system made of Nitinol. There is no mention of AI, ML, image processing, or any software component that would suggest the use of such technologies. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described for use in fracture and osteotomy fixation, as well as joint arthrodesis, which are therapeutic medical procedures.
No
Explanation: The device is a system for fracture, osteotomy, and joint arthrodesis fixation, which are treatment procedures, not diagnostic ones. It is designed to provide mechanical support and promote fusion, not to identify or assess a medical condition.
No
The device description explicitly states that the system consists of an implant made of Nitinol and associated instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical fixation of bone fragments, fractures, osteotomies, and joint arthrodesis. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (staples) made of Nitinol, designed for mechanical support and compression of bone.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / 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.
Product codes
JDR
Device Description
The A'TOMIC™ 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'TOMIC™ Nitinol Fixation System implant. Reusable instrumentation will also be available as an option for the surgeon and facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
short, long, or flat bones.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
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"
1
(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.
2
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)
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.
5
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. |
| (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
A'TOMIC™ Nitinol
Fixation System Implant | Primary
BME Speed™ Implant
(Predicate cleared under
K142292) | Proposed vs
Primary |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Product Code | JDR | JDR | Same |
| Regulation # | 888.3030 | 888.3030 | Same |
| Class | II | II | Same |
| Classification
Name | Staple, Fixation, Bone | Staple, Fixation, Bone | Same |
| 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 precludes 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. | The Speed™, Speed Shift™,
Speed Titan™ and Speed
Arc™ are indicated for:
Fracture and osteotomy
fixation and joint
arthrodesis of the hand
and foot.Fixation of proximal tibial
metaphysis osteotomy.Hand and foot bone
fragments, osteotomy
fixation and joint
arthrodesis.Fixation of small
fragments of bone (i.e.,
small fragments of bone
which are not
comminuted to the extent
to preclude staple
placement). These
fragments may be located
in long bones such as the
femur, fibula and tibia in
the lower extremities; the
humerus, ulna or radius in
the upper extremities; the
clavicle and ribs; and in
flat bone such as the
pelvis, scapula and
sternum. | No significant
difference. |
| | Proposed
A'TOMICTM Nitinol
Fixation System Implant | Primary
BME Speed™ Implant
(Predicate cleared under
K142292) | Proposed vs
Primary |
| Contraindications | Infection Patients with mental or
neurologic conditions
who are unwilling or
incapable of following
postoperative care
instructions. Patient conditions
including blood supply
limitations, obesity, and
insufficient quantity or
quality of bone that
would impair the ability
to securely fix the
implant. Comminuted bone
surface that would hinder
staple placement. Foreign body sensitivity
to metals. Where material
sensitivity is suspected,
appropriate tests should
be made prior to
implantation. | Comminuted bone surface
that would militate
against staple placement Pathologic conditions of
bone such as osteopenia
that would impair the
ability to securely fix the
implant Foreign body sensitivity
to metals including
nickel. Where material
sensitivity is suspected,
appropriate tests should
be made prior to
implantation | No significant
difference. |
| Prescription or
OTC? | Prescription | Prescription | Same |
| Sterility Method | Device Provided Sterile,
Sterilized with Gamma
Irradiation | Device Provided Sterile,
Sterilized with Gamma
Irradiation | Same |
| Sterility
Assurance Level
(SAL) |