The Precice Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

Device Description

The Precice Ankle Salvage System is a tibio-talo-calcaneal fusion system that consists of the Precice Ankle Salvage nail, locking screws, end caps, and associated general instruments. The Precice Ankle Salvage nail is compatible with an accessory External Remote Controller (ERC). The Precice Ankle Salvage nail, endcap, and locking screws are supplied sterile by gamma radiation. The Precice Ankle Salvage nail contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the nail to be adjusted non-invasively by the ERC. Retraction of the Precice Ankle Salvage nail can be utilized to maintain compression across the tibio-talo-calcaneal ioints post-operatively. The Precice Ankle Salvage nail can also be used to subsequentially correct a limb length discrepancy that may result after the tibio-talo-calcaneal fusion procedure. The subject device is manufactured from medical grade Titanium alloy (Ti-6Al-4V) per ASTM F136. The Precice Ankle Salvage nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Precice Ankle Salvage System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results of a device's performance against specific acceptance criteria in a human-in-the-loop or standalone AI context.

Therefore, most of the requested information regarding acceptance criteria, human reader improvement with AI assistance, sample size for test/training sets, expert qualifications, ground truth establishment, and adjudication methods cannot be extracted from the provided text because this document is a regulatory submission for a physical medical device (an intramedullary fixation rod system), not an AI/software as a medical device (SaMD).

The document describes non-clinical performance verification testing for the physical device's mechanical properties, not clinical performance for diagnostic or prognostic purposes typically associated with AI/SaMD.

Here's a breakdown of what can be extracted and what cannot:

Information that can be extracted:

Device Name: Precice Ankle Salvage System
Regulatory Class: Class II
Product Code: HSB (Intramedullary Fixation Rod), HWC (Smooth or threaded metallic bone fixation fastener)
Intended Use/Indications for Use: For tibio-talo-calcaneal fusions in adults, for fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. May be used for subsequent limb lengthening once fusion is achieved.
Predicate Devices: Precice Ankle Salvage System (K200430) and Precice Intramedullary Limb Lengthening System (K220234).
Material: Titanium alloy (Ti-6Al-4V) per ASTM F136.

Information that CANNOT be extracted from this document, as it pertains to AI/SaMD studies:

Acceptance Criteria Table and Reported Device Performance (as pertains to AI/SaMD): Not applicable. The document lists mechanical tests for the physical device, not AI-driven performance metrics.
Sample sizes used for the test set and data provenance: Not applicable for an AI study. The document refers to non-clinical mechanical testing, not a clinical study with patients/data.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI diagnostic device is not relevant here.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not for this type of device.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Study for the Physical Device (as present in the document):

The document defines acceptance criteria for the mechanical performance of the physical implant and demonstrates its substantial equivalence to predicate devices through non-clinical performance verification testing.

1. A table of acceptance criteria and the reported device performance

Testing Description	Applicable Standard	Acceptance Criteria (Implicit)	Reported Device Performance
Dynamic Compression Bending Strength	ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices	Device meets the requirements of ASTM F1264 for dynamic mechanical loads typical of intramedullary fixation devices.	Results demonstrate substantial equivalence to the primary predicate.
Static Compression Bending Strength	ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices	Device meets the requirements of ASTM F1264 for static mechanical loads typical of intramedullary fixation devices.	Results demonstrate substantial equivalence to the primary predicate.
Torsion	ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices	Device meets the requirements of ASTM F1264 for torsional strength typical of intramedullary fixation devices.	Results demonstrate substantial equivalence to the primary predicate.
Tensile Strength	ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices	Device meets the requirements of ASTM F1264 for tensile strength typical of intramedullary fixation devices.	Results demonstrate substantial equivalence to the primary predicate.
Axial Pullout Strength	ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws	Screws meet the requirements of ASTM F543 for axial pullout strength.	Results demonstrate substantial equivalence to the primary predicate.
Insertion Torque	ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws	Screws meet the requirements of ASTM F543 for insertion torque.	Results demonstrate substantial equivalence to the primary predicate.
Ultimate Torque	ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws	Screws meet the requirements of ASTM F543 for ultimate torque.	Results demonstrate substantial equivalence to the primary predicate.
Distraction and Retraction Force	N/A (Internal Test)	Mechanical forces required for distraction and retraction are within acceptable limits for the intended function of the device's lengthening mechanism.	Results demonstrate substantial equivalence to the primary predicate.
Wear Debris Testing	N/A (Internal Test)	Minimal and acceptable wear debris generation.	Results demonstrate substantial equivalence to the primary predicate.
Corrosion Assessment	N/A (Internal Test)	Device materials demonstrate acceptable corrosion resistance.	Results demonstrate substantial equivalence to the primary predicate.

Study that proves the device meets the acceptance criteria:

The study proving the device meets its acceptance criteria is the "Nonclinical performance verification testing" conducted by NuVasive Specialized Orthopedics, Inc.

Type of Study: Non-clinical (benchtop) mechanical and material testing.
Purpose: To demonstrate that the subject Precice Ankle Salvage System, with its new titanium material and minor design changes, is substantially equivalent in terms of mechanical performance to its predicate devices.
Methodology: The device components were subjected to various mechanical tests (dynamic/static compression bending, torsion, tensile, axial pullout, insertion/ultimate torque) according to recognized ASTM standards (F1264, F543) and internal methods (Distraction and Retraction Force, Wear Debris Testing, Corrosion Assessment).
Results/Conclusion: "The results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the primary predicate." This implies that the device's performance metrics in these tests were comparable to or better than the predicate device, thereby meeting the necessary performance benchmarks for regulatory clearance.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

August 29, 2023

NuVasive Specialized Orthopedics, Inc. Miriam Cervantes Senior Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656

Re: K230765

Trade/Device Name: Precice Ankle Salvage System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: July 28, 2023 Received: July 31, 2023

Dear Miriam Cervantes:

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.

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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 (QS) 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,

Farzana	Digitally signed byFarzana Sharmin -S
Sharmin -S	Date: 2023.08.2917:48:49 -04'00'

Farzana Sharmin, 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

510(k) Number (if known) K230765

Device Name Precice Ankle Salvage System

Indications for Use (Describe)

The Precice Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talocalcaneal fusion, the Precice Ankle Salvage System may be used fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

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/3/Picture/0 description: The image is a logo for "NUVASIVE SPECIALIZED ORTHOPEDICS, INC." The logo features a stylized leaf-like shape in purple and gray on the left. To the right of the leaf is the word "NUVASIVE" in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in purple underneath.

Precice Ankle Salvage System 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:

A. Submitted by:

Miriam Cervantes mcervantes@nuvasive.com Senior Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (909) 229-7836

Date Prepared: August 23, 2023

B. Device Name

Trade or Proprietary Name:	Precice Ankle Salvage System
Common or Usual Name:	Rod, Fixation, Intramedullary and Accessories
Classification Name:	Intramedullary Fixation Rod
Device Class:	Class II
Classification:	21 CFR § 888.3020
Product Code:	HSB
Common or Usual Name:	Screw, Fixation, Bone
Classification Name:	Smooth or threaded metallic bone fixation fastener
Device Class:	Class II
Classification:	21 CFR § 888.3040
Product Code:	HWC

C. Predicate Devices

The subject Precice Ankle Salvage System is substantially equivalent to the primary predicate device Precice Ankle Salvage System (K200430). The Precice Intramedullary Limb Lengthening System (K220234) served as an additional predicate.

D. Device Description

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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic to the left of the company name. The company name is in silver, with the words "SPECIALIZED ORTHOPEDICS, INC." in purple below.

invasively by the ERC. Retraction of the Precice Ankle Salvage nail can be utilized to maintain compression across the tibio-talo-calcaneal ioints post-operatively. The Precice Ankle Salvage nail can also be used to subsequentially correct a limb length discrepancy that may result after the tibio-talo-calcaneal fusion procedure.

The purpose of this submission is to implement material and design changes to the predicate Precice Ankle Salvage System (K200430) to create a product line extension which includes the Precice Ankle Salvage nail, end caps, and locking screws in titanium. The subject device is manufactured from medical grade Titanium alloy (Ti-6Al-4V) per ASTM F136. The Precice Ankle Salvage nail is available in various nail styles, diameters, and lengths to accommodate a variety of patient anatomies and surgeon preference. The locking screws are available in a variety of diameters, lengths, and thread styles. The ERC is available in several compatible models. These modifications do not change the indications for use or intended use of the device, nor do they change the fundamental scientific technology of the device.

E. Indications for Use

The Precice Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibiotalo-calcaneal fusion has been achieved.

F. Comparison of Indications for use with the Predicate Device

The Precice Ankle Salvage System has the same intended use as the predicate device Precice Ankle Salvage System (K200430). Both the subject and predicate device achieve tibio-talocalcaneal fusion by providing sustained compression across the fusion site post-operatively. The subject device indications for use differ from the predicate device Precice Ankle Salvage System (K200430) indications by specifying that it is for adults. This difference in indications does not change the intended use or fundamental scientific technology of the device so it does not affect the intended surgical use or the safety and effectiveness of the device.

Additionally, the Precice Ankle Salvage System has the same intended use as both the predicate Precice Ankle Salvage System (K200430) and Precice Intramedullary Limb Lengthening System (K220234) for fracture fixation and limb lengthening.

Therefore, the subject device does not create a new intended use.

G. Comparison of Technological Characteristics with the Predicate Device

As was established in this submission, the subject Precice Ankle Salvage System is substantially equivalent to the primary precice Ankle Salvage System (K200430), which was previously cleared by the FDA for commercial distribution in the United States. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to the predicates through comparison in areas including design, principles of operation, labeling/intended use, material composition, and function.

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The following table describes the summary comparison of technological characteristics of the subject device with the predicate devices.

Predicate	Subject Device	Precice Ankle SalvageSystem (K200430)	Precice Intramedullary LimbLengthening System (K220234)
Indicationsfor Use	The Precice Ankle SalvageSystem is indicated fortibio-talo-calcaneal fusionsin adults. When used fortibio-talo-calcaneal fusion,the Precice Ankle SalvageSystem may be used foropen and closed fracturefixation, pseudarthrosis,mal-unions, non-unions, orbone transport of longbones adjacent to thefusion site. The device maybe used for subsequentlimb lengthening oncetibio-talo-calcaneal fusionhas been achieved.	The Precice Ankle SalvageSystem is intended for tibio-talo-calcaneal fusions. Whenused TTC fusion, the PreciceAnkle Salvage System maybe used for open and closedfracture fixation,pseudarthrosis, mal-unions,non-unions, or bone transportof long bones adjacent to thefusion site. The device maybe used for subsequent limblengthening once tibio-talo-calcaneal fusion has beenachieved.	The Precice IntramedullaryLimb Lengthening System isindicated for limb lengthening.open and closed fracturefixation, pseudarthrosis,malunions, nonunions, or bonetransport of long bones inpatients age 18 years and olderand indicated for limblengthening of the femur andtibia in pediatric patients(greater than 12 years old).
Summary ofthe subjectdevicetechnologysimilaritiescompared tothe predicatedevice	Principle of Operation:sustained compressionacross the fusion site &distraction osteogenesisGeometry: similar implantdesign and identicaldiameters and lengths forthe nailMaterial Composition:Titanium alloy (Ti-6A1-4V)Similar screw diametersand styles	Principle of Operation:sustained compression acrossthe fusion site & distractionosteogenesisGeometry: similar implantdesign and identicaldiameters and lengths for thenailSimilar screw diameters andstyles	Principle of Operation:distraction osteogenesisMaterial Composition:Titanium alloy (Ti-6A1-4V)Similar screw diameters andstyles
Summary ofthe subjectdevicetechnologydifferencescompared tothe predicatedevice	Similar to K200430 butoffered in the samematerial as K220234	Device offers screwdiameters in longer lengthsthan the subject device	Device nail is not offered with athreaded distal end like thesubject deviceDevice nail offers a longer totalstroke length for limblengthening than the subjectdeviceDevice screws not offered in alarger screw diameter like thesubject device

H. Performance Data

Nonclinical performance verification testing was performed to demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicate devices.

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Image /page/6/Picture/0 description: The image is a logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized purple and silver graphic on the left, followed by the word "NUVASIVE" in silver, and the words "SPECIALIZED ORTHOPEDICS, INC." in purple below it. The logo is clean and modern, with a focus on the company's name and specialization.

The following testing was performed:

Testing Description	Applicable Standard
Dynamic CompressionBending Strength	ASTM F1264 - Standard Specification and TestMethods for Intramedullary Fixation Devices
Static CompressionBending Strength	ASTM F1264 - Standard Specification and TestMethods for Intramedullary Fixation Devices
Torsion	ASTM F1264 - Standard Specification and TestMethods for Intramedullary Fixation Devices
Tensile Strength	ASTM F1264 - Standard Specification and TestMethods for Intramedullary Fixation Devices
Axial Pullout Strength	ASTM F543 - Standard Specification and TestMethods for Metallic Medical Bone Screws
Insertion Torque	ASTM F543 - Standard Specification and TestMethods for Metallic Medical Bone Screws
Ultimate Torque	ASTM F543 - Standard Specification and TestMethods for Metallic Medical Bone Screws
Distraction andRetraction Force	N/A
Wear Debris Testing	N/A
Corrosion Assessment	N/A

The results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the primary predicate.

I. Conclusions

The subject device, the Precice Ankle Salvage System, has been shown to be substantially equivalent to the legally marketed primary predicate device for its intended use.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.