The intended use/indications for use of the predicate devices identified remain the same as previously cleared in their respective 510(k)s. The respective 510(k)s for the devices can be referenced in the predicate device section above.

Device Description

The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.

AI/ML Overview

This is a 510(k) summary for a submission that adds MR Conditional information to the labeling of several existing medical devices. The submission does not introduce new devices or changes to the fundamental design, materials, or indications for use of the listed devices. Therefore, the "acceptance criteria" and "device performance" in this context relate to the MR compatibility of the devices according to established standards.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Reported Device Performance
Magnetically Induced Displacement Force (ASTM F2052)	The devices were tested and found to be MR conditional. (Specific force values or thresholds are not provided in this summary, but the conclusion states conditional MRI safety was established).
Magnetically Induced Torque (ASTM F2213)	The devices were tested and found to be MR conditional. (Specific torque values or thresholds are not provided in this summary, but the conclusion states conditional MRI safety was established).
RF-induced Heating (ASTM F2182)	The devices were tested and found to be MR conditional. (Specific temperature increases or thresholds are not provided in this summary, but the conclusion states conditional MRI safety was established).
Image Artifact (ASTM F2119)	The devices were tested and found to be MR conditional. (Specific artifact sizes or impacts are not provided in this summary, but the conclusion states conditional MRI safety was established).
Overall MR Compatibility (per ASTM F2503 and FDA Guidance)	The completed MR compatibility testing establishes the conditional safety and compatibility of the passive implant devices in the MR environment, and supports the addition of MR Conditional labeling.

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

Sample Size for Test Set: Not explicitly stated in the provided text. For MR compatibility testing, the "sample size" typically refers to the number of device models/configurations tested. It's implied that "the devices" (referring to the listed product lines and their components) were tested.
Data Provenance: The nature of this testing (MR compatibility) suggests it was conducted in a controlled environment as a prospective evaluation of the devices. The country of origin of the data is not specified but would likely have been where the testing laboratory is located, presumably in a country with recognized testing standards (e.g., USA or Europe).

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

This type of submission (MR compatibility of implants) does not typically involve human expert "ground truth" derived from clinical images. The "ground truth" here is objective measurements against engineering standards for MR safety and compatibility. The "experts" would be the engineers and physicists conducting the tests and interpreting the results according to ASTM standards and FDA guidance. Their qualifications would be expertise in MR safety testing and relevant engineering fields.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of human-interpreted data. The results are based on objective physical measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for device labeling updates based on physical properties (MR compatibility), not for evaluating the clinical effectiveness of a diagnostic or therapeutic algorithm with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is about the physical properties of medical implants in an MRI environment, not about an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" used is defined by internationally recognized engineering standards for MR compatibility: ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2182 (RF-induced heating), and ASTM F2119 (image artifact). The FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" also serves as a framework for the "ground truth" criteria.

8. The Sample Size for the Training Set

Not applicable. This submission is about MR compatibility testing of existing devices, not about developing or training an AI algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 27, 2021

Integra Lifesciences Corporation Blesson Abraham Senior Regulatory Affairs Specialist 11101 Metric Blvd Austin, Texas 78758

Re: K210016

Trade/Device Name: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw.NewDeal TIBIAXYS System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 18, 2021 Received: June 22, 2021

Dear Blesson Abraham:

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.

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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 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 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.

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K210016

Device Name

Integra DigiFuse Cannulated Intramedullary Fusion System,Integra CAPTURE Screw System & Integra Tí6 Internal Fixation System,Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System.

Indications for Use (Describe)

The DigiFuse® implant is indicated for the fixation

of osteotomies and reconstruction of the lesser

phalanges during procedures to correct deformities of the toes and fingers.

Indications include:

· Hammer toe deformity

· Claw toe deformity
· Mallet toe deformity

· Other deformities of the feet and hands

The DigiFuse® implants are intended for single use only.

Integra(r) total foot system is indicated for skeletally mature patients for the following:

-stabilization and fixation of fresh fractures

-intra and extra articular fractures, joint depression, and multi-fragmentary fractures

-revision procedures, joint fusion, and reconstruction of small bones of the feet.

The indications for use for the Integra® CAPTURE™ Screw System are as follows: "The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the hand and foot. The implants are intended for single use only.

The indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6® Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

The Subtalar MBA System is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.

*Severely pronated foot

*Walking intemperence

*Calcaneal stance position great than 5 degrees
*Manually correctable deformities

*Mid-tarsal breech (arch pain)

*Forefoot varus greater than 10 degrees

The metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and meical displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Indications include: severe pronation Calcaneal valgus deformity plantarflexed talus failed correction with long term orthotic treatment congenital and painful flatfoot deformity repair of tarsal coalitions subtalar instability

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posterior tibial tendon dysfunction

paralytic flat foot deformity

The metasurg subtalar implants are intended for single use only.

The "new" bold screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

fixation of small bone fragments, in long bones or small bones fractures.
arthrodesis in hand or foot surgery
mono or bi-cortical osteotomies in the foot or hand
distal or proximal metatarsal or metacarpal osteotomies
fixation of osteotomies for hallux valgus treatment (such as scarf, chevron, etc.)

The hallu lock plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of:

hallux rigidus

severe hallux valgus (im angle>20 degrees and hv angle >40 degrees)

deformity from rheumatoid arthritis

failed previous surgical procedures

traumatic arthritis

neuromuscular instability

the hallu lock plates must be fixed with tixed angle locking system and with the surfix-alpha variable angle locking system of 2.7mm or 3.0mm diameter (scews and lock-screws). Addition of a newdeal quix screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

The hallu plates are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarsophalangeal joint, including cases of:

hallux rigidus

severe hallux valgus (im angle > 20 degree and hv angle >40 degree)

deformity from rheumatoid arthritis

failed previous surgical procedure

traumatic arthritis

neuromuscluar instability

The plates have to be fixed with the snap-off screws. Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

The quix positioning screw is indicated for fixation of bone reconstruction. Examples include:

- mono or bi-cortical osteotomies in the foot or hand (including hallux valgus treatment)
- fractures management in the foot or hand
- fixation of bone fragments in long bones or small bones fractures
*arthrodesis in hand, foot and ankle surgery

The size of the chosen screw should be adapted to the specific indication.

The "new" spin" snap-off screw is indicated for fixation of bone fractures of for bone reconstruction. Examples include:

fixation of small bone fragments
weil osteomy
mono-cortical fixation
osteotomies and fractures fixation in the foot and hand.

The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS Plates have to be fixed with the SURFIX and SURFIX ALPHA 3.5mm

diameter Locking System (screws and Lock screws).

Anterior plates for ankle Arthrodesis have to be fixed with the TIBIAXYS 4.0mm diameter cortical

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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

Sponsor	Ascension Orthopedics, Inc.11101 Metric Blvd.Austin, TX 78758
Establishment Number	3014207283
Point of Contact	Blesson Abraham11101 Metric Blvd.Austin, TX 78758
Date	June 18, 2021
Trade Name	This 510(k) applies to multiple product lines, as identified below, as this is abundled 510(k) per FDA Guidance Document, Bundling Multiple Devices orMultiple Indications in a Single Submission .1. Integra DigiFuse Cannulated Intramedullary Fusion System2. Integra Total Foot System3. Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System4. Subtalar MBA System5. MetaSurg Subtalar Implant6. NewDeal BOLD Screw7. New HALLU Lock Plate System8. NewDeal HALLU Plates9. QWIX Positioning Screw10. SPIN Snap-Off Screw11. NewDeal TIBIAXYS System
Common Name	1. Cannulated Intramedullary Fusion System2. Plate, Fixation, Bone3. Bone Screw4. Subtalar Arthrorisis Implant5. Subtalar Arthrorisis Implant6. Bone Fixation Screw, Cannulated Compression Screw7. Plate, Fixation, Bone8. Plate, Fixation, Bone9. Bone Fixation Screw10. Bone Fixation Screw, Self-Drilling and Self-Tapping Snap-Off Screw11. Plate, Fixation, Bone
Classification Name	1. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)2. HRS – Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030)3. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)4. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)5. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)6. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)7. HRS – Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030)8. HRS – Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030)9. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
	10. HWC - Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)11. HRS - Single/multiple component metallic bone fixation appliances andaccessories (21 CFR 888.3030)
Classification	Class II
PredicateDevice	Primary Predicate1. K152527 - Integra DigiFuse Cannulated Intramedullary Fusion SystemAdditional predicates are as follows and identified with the corresponding referencefrom the previous sections of this 510(k) summary.2. K123000 - Integra Total Foot System3. K162153 – Integra Capture Internal Fixation System & Integra Ti6 InternalFixation System4. K960692 – Subtalar MBA System5. K111265 – MetaSurg Subtalar Implant6. K011262 - NewDeal BOLD Screw7. K083154 - NewDeal HALLU Lock Plate System8. K093781 - NewDeal HALLU Plates9. K071639 – QWIX Positioning Screw10. K011946 - SPIN Snap-Off Screw11. K073375 - NewDeal TIBIAXYS System
ClassificationPanel	Orthopedic
DeviceDescription	The purpose of this submission is the addition of MR Conditional information to thelabeling for the predicate devices. The addition of MR labeling to the subjectdevices does not impact indications, materials, design features or dimensions,packaging or sterilization.
Intended Use/Indications forUse	The intended use/indications for use of the predicate devices identified remain thesame as previously cleared in their respective 510(k)s. The respective 510(k)s forthe devices can be referenced in the predicate device section above.
NonclinicalPerformanceData	Non-clinical Magnetic Resonance Imaging (MRI) testing performed on the devicesdetermined the devices are MR conditional in accordance with ASTM F2503(Standard Practice for Marking Medical Devices and Other Items for Safety in theMagnetic Resonance Environment) and FDA Guidance (Establishing Safety andCompatibility of Passive Implants in the Magnetic Resonance (MR) Environment).MR Testing addressed the following:1. Magnetically Induced Displacement Force (ASTM F2052)2. Magnetically Induced Toque (ASTM F2213)3. RF-induced heating (ASTM F2182)4. Image Artifact (ASTM F2119)
Conclusion	The completed MR compatibility testing establishes the conditional safety andcompatibility of the passive implant devices in the MR environment, and theaddition of MR Conditional labeling.

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K210016 Page 2 of 2

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.