(208 days)
No
The description focuses on mechanical and magnetic mechanisms for length adjustment and does not mention any AI/ML components or functions.
Yes
The device is intended for tibio-talo-calcaneal fusions and may be used for various conditions such as open/closed fracture fixation, pseudarthrosis, mal-unions, bone transport, and limb lengthening. These uses directly involve the treatment or management of medical conditions and injuries.
No
The device is described as a "tibio-talo-calcaneal fusion system" intended for surgical procedures like fracture fixation, pseudarthrosis, mal-unions, bone transport, and limb lengthening. It is an implantable medical device used for treatment and reconstruction, not for providing diagnostic information about a patient's condition.
No
The device description clearly outlines multiple hardware components including a nail, screws, end caps, and an external remote controller (ERC). While the ERC might contain software, the core device is a physical implantable system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for tibio-talo-calcaneal fusions, fracture fixation, pseudarthrosis, mal-unions, bone transport, and limb lengthening. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is an implantable system (nail, screws, end caps) used for structural support and adjustment within the body. It also includes an external remote controller for non-invasive adjustment.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for surgical treatment and structural support.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibio-talo-calcaneal joints
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Dynamic Compression Bending Strength
- Axial Pullout Strength
- Insertion Torque
- Torque Resistance
- Distraction and Retraction Force
Applicable standards included ASTM F1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices, and ASTM F543 - Standard Specification and Test Methods for Metallic Medical Bone Screws.
The results demonstrate that the subject Precice Ankle Salvage System is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
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
1
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)
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 tibiotalo-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 shows the 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 written in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in smaller letters below the name.
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
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.
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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, abstract shape on the left, which is partially purple and partially gray. To the right of the shape, the word "NUVASIVE" is written in gray, block letters. Below "NUVASIVE", the words "SPECIALIZED ORTHOPEDICS, INC." are written in a smaller, purple font.
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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Image /page/5/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized, abstract shape in purple and gray on the left. To the right of the shape is the company name, "NUVASIVE," in gray, block letters. Below the name, in smaller letters, is the phrase "SPECIALIZED ORTHOPEDICS, INC." also in gray.
| 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 site |
Similarities in Geometry:
similar implant design
similar screw length and style
(headed & headless) | Principle of Operation:
distraction osteogenesis
Material 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 nails
subject nail offers additional smaller and larger screw diameters of the same length
subject nail is offered with a threaded distal end
subject nail uses internal gears and magnetic coupling instead of nitinol compressive elements | Differences in Geometry:
subject nail is offered with a threaded distal end
subject nail offers additional larger screw diameter and lengths
subject 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 Compression | |
| Bending Strength | ASTM F1264 - Standard Specification and Test |
| Methods for Intramedullary Fixation Devices | |
| Axial Pullout Strength | |
| Insertion Torque | ASTM F543 - Standard Specification and Test |
| Methods for Metallic Medical Bone Screws | |
| Torque Resistance | |
| Distraction and | |
| Retraction 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.