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 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.

AI/ML Overview

This FDA 510(k) premarket notification describes the A'TOMIC™ Nitinol Fixation System, a medical device for bone fixation. However, it does not contain a study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical performance with human readers and AI.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (BME Speed™ Implant) through a comparison of technological characteristics and non-clinical mechanical performance testing.

Therefore, many of the requested details such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets are not applicable to this type of regulatory submission. The information provided is primarily related to the device's physical and mechanical properties.

Here's an breakdown of the information that is available in the document, tailored to your request, with an emphasis on what is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) and "reported device performance" are not directly addressed in this 510(k) for a fixation system. Instead, the "acceptance criteria" are implied by the standards and the performance of the predicate device for mechanical and material properties. The "reported device performance" refers to the results of the non-clinical mechanical tests demonstrating it meets these standards and is comparable to the predicate.

Performance Metric (Acceptance Criteria)	Reported Device Performance (A'TOMIC™ Nitinol Fixation System)
Mechanical Performance:
Static Four Point Bend (per ASTM F564-17)	Results demonstrate sufficient mechanical performance for intended use and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.)
Static Pull-out (per ASTM F564-17)	Results demonstrate sufficient mechanical performance for intended use and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.)
Corrosion Resistance:
Cyclic Corrosion (per ASTM F2129-19a)	Results demonstrate sufficient performance and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.)
Biocompatibility/Safety (Implied):
Pyrogen and Endotoxins Testing (per ANSI/AAMI ST72)	Results demonstrate sufficient performance and no new questions of safety or efficacy compared to the predicate. (Quantitative values not provided in this summary.)
Material Composition (Substantial Equivalence):
Implant Material: Nitinol	Same as predicate. (ASTM F2063-18 grade in device description)
Sterility Assurance Level (SAL):
<10-6	<10-6 (Same as predicate)
General Safety & Efficacy:	No new questions of safety or efficacy were identified based on the non-clinical testing and comparison to the predicate device, supporting substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This document describes non-clinical mechanical and material testing, not a study involving a test set of data (e.g., medical images) to assess diagnostic accuracy or clinical outcomes. The "test set" here refers to the samples of the device used for mechanical and material tests. The specific number of devices tested for each mechanical test is not provided in this summary.
Data Provenance: Not applicable. The data is generated from laboratory mechanical and material tests performed on the physical device. Country of origin of data is not relevant in this context. The study is a non-clinical, prospective testing of prototypes or production samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this type of device and submission. The tests are mechanical and material property assessments against established standards.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for comparing the performance of diagnostic tools (e.g., AI systems) with and without human assistance, which is not the purpose of this 510(k) submission for a bone fixation system.

6. Standalone Performance

Not applicable in the context of an "algorithm only without human-in-the-loop performance." This device is a physical implant. Its "standalone performance" refers to its mechanical and material integrity as an implant. The non-clinical tests assess this.

7. Type of Ground Truth Used

Not applicable in the sense of expert consensus, pathology, or outcomes data for diagnostic accuracy. For the mechanical and material tests, the "ground truth" is defined by the objective physical and chemical properties and performance as measured against recognized industry standards (e.g., ASTM F564-17, ASTM F2129-19a, ANSI/AAMI ST72).

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device requiring data for algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated above.

Summary

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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)

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.(DePuy Synthes)

F. Device Description:

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.

	ProposedA'TOMIC™ NitinolFixation System Implant	PrimaryBME Speed™ Implant(Predicate cleared underK142292)	Proposed vsPrimary
Product Code	JDR	JDR	Same
Regulation #	888.3030	888.3030	Same
Class	II	II	Same
ClassificationName	Staple, Fixation, Bone	Staple, Fixation, Bone	Same
Indications forUse	The A'TOMIC™ NitinolFixation System is indicatedfor use in fracture, osteotomyfixation and joint arthrodesisas well as fixation of bonefragments (i.e., smallfragments of bone which arenot comminuted to the extentthat precludes stapleplacement). The device isintended for use in short, long, orflat bones. TheA'TOMIC™ Nitinol FixationSystem is intended for singleuse only.	The Speed™, Speed Shift™,Speed Titan™ and SpeedArc™ are indicated for:Fracture and osteotomyfixation and jointarthrodesis of the handand foot.Fixation of proximal tibialmetaphysis osteotomy.Hand and foot bonefragments, osteotomyfixation and jointarthrodesis.Fixation of smallfragments of bone (i.e.,small fragments of bonewhich are notcomminuted to the extentto preclude stapleplacement). Thesefragments may be locatedin long bones such as thefemur, fibula and tibia inthe lower extremities; thehumerus, ulna or radius inthe upper extremities; theclavicle and ribs; and inflat bone such as thepelvis, scapula andsternum.	No significantdifference.
	ProposedA'TOMICTM NitinolFixation System Implant	PrimaryBME Speed™ Implant(Predicate cleared underK142292)	Proposed vsPrimary
Contraindications	Infection Patients with mental orneurologic conditionswho are unwilling orincapable of followingpostoperative careinstructions. Patient conditionsincluding blood supplylimitations, obesity, andinsufficient quantity orquality of bone thatwould impair the abilityto securely fix theimplant. Comminuted bonesurface that would hinderstaple placement. Foreign body sensitivityto metals. Where materialsensitivity is suspected,appropriate tests shouldbe made prior toimplantation.	Comminuted bone surfacethat would militateagainst staple placement Pathologic conditions ofbone such as osteopeniathat would impair theability to securely fix theimplant Foreign body sensitivityto metals includingnickel. Where materialsensitivity is suspected,appropriate tests shouldbe made prior toimplantation	No significantdifference.
Prescription orOTC?	Prescription	Prescription	Same
Sterility Method	Device Provided Sterile,Sterilized with GammaIrradiation	Device Provided Sterile,Sterilized with GammaIrradiation	Same
SterilityAssurance Level(SAL)	<10-6	<10-6	Same
Packaging ofImplant Kits	Packaged withinserter/retention deviceinside a single sterile barrierpouch.	Packaged with inserter inside asingle sterile barrier pouch	No significantdifference.
	ProposedA'TOMICTM NitinolFixation System Implant	PrimaryBME Speed™ Implant(Predicate cleared underK142292)	Proposed vsPrimary
Implant Material	Nitinol	Nitinol	Same
AdditionalInstrumentsMaterial	Medical Grade Plastic andStainless Steel	Medical Grade Plastic andStainless Steel	No significantdifference.
Design/PhysicalCharacteristics	Natural arc on the bridge tomatch the contour of bones,round legs to match profile ofdrill holes, barbs on legs toincrease pullout strength. Thestaple is constrained in theopen position before releaseinto the surgical site.	Natural arc on the bridge tomatch the contour of bones,squared legs, and barbs on legsto increase pullout strength.The staple is constrained in theopen position before releaseinto the surgical site.	No significantdifference.

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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.

Regulation Number and Section

§ 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.