The Precice Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC 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 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 external remote controller (ERC). The Precice Ankle Salvage Nail and endcap are supplied sterile by gamma radiation. The locking screws are offered either sterile or non-sterile. 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 joints post-operatively. The Precice Ankle Salvage Nail can also be used to correct a limb length discrepancy that may result after the TTC fusion procedure. The subject device is manufactured from medical grade Biodur 108 alloy per ASTM F2229. 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

I am sorry, but the provided text does not contain the information necessary to describe the acceptance criteria and the study proving the device meets those criteria, as requested in your prompt.

The document is a 510(k) premarket notification summary from the FDA, which focuses on establishing "substantial equivalence" of a new medical device (Precice® Ankle Salvage System) to already legally marketed predicate devices.

Here's why the requested information is absent:

No Acceptance Criteria or Performance Data: The document states that "Nonclinical performance verification testing was performed to demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicate devices." It lists types of testing performed (Dynamic Compression, Bending Strength, Axial Pullout Strength, Insertion Torque, Torque Resistance, Distraction and Retraction Force) and applicable ASTM standards. However, it does not provide any specific acceptance criteria (e.g., "must achieve X MPa bending strength") nor does it report the device's actual performance results against any such criteria. It only states that the "results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicates."
No Clinical Study Details: The document mentions a "cadaver lab was performed to address creation of osteotomy around the nail," but this is a pre-clinical, non-human study. There is no mention of a human clinical study, MRMC study, or any details about test set size, data provenance, expert ground truth, adjudication methods, or training set details. This type of information is typically found in clinical study reports, which are not part of this 510(k) summary.
Focus on Substantial Equivalence, Not De Novo Performance: The core purpose of a 510(k) submission is to argue that a new device is "substantially equivalent" to a predicate device. This means demonstrating that it's as safe and effective as a device already on the market, rather than proving its absolute performance against predefined metrics in a clinical setting like a PMA de novo submission often requires.

Therefore, I cannot populate the table or answer the specific questions about the study design, experts, ground truth, or sample sizes because that information is not present in the provided text.

Summary

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

Re: K200430

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: August 17, 2020 Received: August 19, 2020

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.

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

September 16, 2020

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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 mediation-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,

For Michael Owens 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) K200430

Device Name Precice® Ankle Salvage 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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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 Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (909) 229-7836

Date Prepared: September 15, 2020

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 and 888.3040
Product Code:	HSB, HWC

C. Predicate Devices

The subject Precice Ankle Salvage System is substantially equivalent to the following predicate devices:

For tibio-talo-calcaneal fusion the Precice Ankle Salvage System is substantially equivalent to the predicate device DynaNail TTC Fusion System (K171376).

For fracture fixation, including opened and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site, and for subsequent limb lengthening the Precice Ankle Salvage System is substantially equivalent to the predicate device Precice Stryde System (K180503).

In addition, the following reference device was used to establish substantial equivalence, Precice System (K173129).

D. Device Description

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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 joints post-operatively. The Precice Ankle Salvage Nail can also be used to correct a limb length discrepancy that may result after the TTC fusion procedure.

The subject device is manufactured from medical grade Biodur 108 alloy per ASTM F2229. 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.

Indications for Use E.

The Precice Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC 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.

F. Comparison of Indications for use with the Predicate Device

The Precice Ankle Salvage System has the same intended use as the predicate device DynaNail TTC Fusion System (K171376) for tibio-talo-calcaneal fusion. Both the subject and predicate device achieve TTC fusion by providing sustained compression across the fusion site postoperatively.

Additionally, the Precice® Ankle Salvage System has the same intended use as the Precice System (K173129) for fracture fixation and limb lengthening.

Therefore, the differences in indications for use between the predicate devices and subject device do 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 predicates, DynaNail TTC Fusion System (K171376), Precice Stryde System (K180503), and Precice System (K173129), which were 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.

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

Predicate	DynaNail TTC Fusion System (K171376)	Precice Stryde System (K180503)
-----------	---------------------------------------------	----------------------------------------

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Intended Use	TTC Fusion	Fracture Fixation and Limb Lengthening
Summary of the subject device technology similarities to the predicate device	Principle of Operation:sustained compression across the fusion siteSimilarities in Geometry:similar implant designsimilar screw length and style(headed & headless)	Principle of Operation:distraction osteogenesisMaterial Composition:Stainless Steel
Summary of the subject device technology differences to the predicate device	Differences in Geometry:subject nail offered in larger diameter of 13mm and longer length nailssubject nail offers additional smaller and larger screw diameters of the same lengthsubject nail is offered with a threaded distal endsubject nail uses internal gears and magnetic coupling instead of nitinol compressive elements	Differences in Geometry:subject nail is offered with a threaded distal endsubject nail offers additional larger screw diameter and lengthssubject nail offers a shorter total stroke length for limb lengthening

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. Additionally, a cadaver lab was performed to address creation of osteotomy around the nail.

The following testing was performed:

Testing Description	Applicable Standard
Dynamic CompressionBending Strength	ASTM F1264 - Standard Specification and TestMethods for Intramedullary Fixation Devices
Axial Pullout Strength
Insertion Torque	ASTM F543 - Standard Specification and TestMethods for Metallic Medical Bone Screws
Torque Resistance
Distraction andRetraction Force	N/A

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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 gray graphic to the left of the company name. The company name is in a sans-serif font, with "NUVASIVE" in a larger font size than "SPECIALIZED ORTHOPEDICS, INC."

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

I. Conclusions

The subject device, the Precice Ankle Salvage System, has been shown to be substantially equivalent to the legally marketed predicate devices 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.