(87 days)
No
The description focuses on mechanical and magnetic components for gradual lengthening/compression and fixation, with no mention of AI or ML terms or functionalities.
Yes
The device is indicated for limb lengthening and the fixation of fractures, pseudoarthrosis, mal-unions, and non-unions of long bones, which are all therapeutic interventions for medical conditions.
No
The device description clearly states its purpose is for limb lengthening and fracture fixation, which are therapeutic interventions, not diagnostic processes.
No
The device description clearly outlines multiple hardware components including the plate, screws, surgical instruments, and an external remote controller (ERC).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones". This describes a surgical implant and system used to physically manipulate and stabilize bones within the body.
- Device Description: The description details a plate, screws, instruments, and an external controller used for implantation and adjustment of the plate. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is implanted inside the body to treat musculoskeletal conditions.
N/A
Intended Use / Indications for Use
The PRECICE® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.
Product codes
KTT, HRS, HWC
Device Description
The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments.
The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.
The purpose of this premarket notification is to market the new device PRECICE Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
Indicated Patient Age Range
pediatrics and small stature adult patients
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
Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicate devices.
The PRECICE Plate System is substantially equivalent to perform limb lengthening demonstrated by preclinical testing. Safety and effectiveness was also demonstrated by engineering analysis to support substantial equivalence of the subject device to the Inter-Os Limb Lengthener (K031875), Orthofix Modulsystem (K955848) and clinical literature.
The PRECICE Plate System is substantially equivalent to perform fracture fixation demonstrated by predicate device testing of Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086) to ASTM F384 and ASTM F543.
Summary testing performed and incorporated by reference from predicate devices:
- Static Compression Bending Strength per ASTM F384: Comparison to Orthofix Modulsystem (K955848) and Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086). Explanation of Substantial Equivalence: Bending load on construct of subject device performs substantially equivalent under the same loading conditions as predicate devices.
- Dynamic Compression Bending strength per ASTM F384: Comparison to Orthofix Modulsystem (K955848) and Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086).
- Engineering Analysis of Bending Construct: Comparison to Orthofix Modulsystem (K955848). Explanation of Substantial Equivalence: Characterization of an offset bending load of the subject device was demonstrated to perform substantially equivalent to the predicate device.
- Torque Resistance per ASTM F543: Comparison to Orthofix Modulsystem (K955848) and Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086). Explanation of Substantial Equivalence: Characterization of torque resistance of subject device is substantially equivalent to the predicate devices.
- Axial Pullout per ASTM F543: Comparison to Orthofix Modulsystem (K955848) and Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086). Explanation of Substantial Equivalence: Characterization of screw pullout force is substantially equivalent to the predicate devices.
- Torsion: Comparison to Orthofix Modulsystem (K955848) and PRECICE STRYDE (K180503). Explanation of Substantial Equivalence: Characterization of torsional strength of subject device is substantially equivalent to the predicate devices.
- Tensile and Collapse Strength: Comparison to Inter-Os Limb Lengthener (K031875) and Orthofix Modulsystem (K955848). Explanation of Substantial Equivalence: Subject device resists tensile loads substantially equivalent to the predicate devices.
- Distraction Force: Comparison to PRECICE STRYDE (K180503) and clinical literature. Explanation of Substantial Equivalence: Distraction force is substantially equivalent to the predicate device.
The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.
Key Metrics
Not Found
Predicate Device(s)
Inter-Os Limb Lengthener (K031875), Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086)
Reference Device(s)
PRECICE STRYDE (K180503), Orthofix Modulsystem (K955848)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
November 7, 2019
Image /page/0/Picture/1 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-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
NuVasive Specialized Orthopedics, Inc. Madison Heffron Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K192181
Trade/Device Name: PRECICE Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, HRS, HWC Dated: August 7, 2019 Received: August 12, 2019
Dear Madison Heffron:
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
1
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 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: Shumaya Ali 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
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
PRECICE® Plating System
Indications for Use (Describe)
The PRECICE® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.
Type of Use (Select one or both, as applicable)
| ☑ Depreciation Use (Part 21 CFR 601 Subpart D) | ☐ Over-The-Counter Use (21 CFR 601 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------- |
|X|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/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf shape in purple and gray on the left. To the right of the leaf shape is the word "NUVASIVE" in gray, with the words "SPECIALIZED ORTHOPEDICS, INC." in smaller purple font below.
PRECICE Plating 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:
Madison Heffron Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (949) 532-7868
Date Prepared: November 6, 2019
B. Device Name
| Trade or Proprietary Name: | PRECICE® Plating System |
|---|---|
| Common or Usual Name: | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple |
| Component | |
| Classification Name: | Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3030 |
| Product Code: | KTT, HRS, HWC |
C. Predicate Devices
The subject PRECICE Plate System is substantially equivalent to the following predicate devices;
For limb lengthening, the Precice Plate System is substantially equivalent to the predicate device Inter-Os Limb Lengthener (K031875),
For fracture fixation, including open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions, the Precice Plate System is substantially equivalent to the predicate device Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086),
In addition, the following reference devices were used to establish substantial equivalence, PRECICE STRYDE (K180503) and Orthofix Modulsystem (K955848).
D. Device Description
The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments.
4
Image /page/4/Picture/1 description: The image contains the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf-like shape on the left, with the top half in purple and the bottom half in silver. To the right of the leaf shape is the word "NUVASIVE" in silver, with the words "SPECIALIZED ORTHOPEDICS, INC." in purple underneath.
The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.
The purpose of this premarket notification is to market the new device PRECICE Plating System.
E. Indications for Use
The PRECICE Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.
F. Comparison of Indications for Use with the Predicate Device
The Precice Plate System is substantially equivalent to the Inter-Os Limb Lengthener (K031875) for limb lengthening. The subject device is intended for use with pediatric and small stature adults compared to the predicate indicated for adults. Safety and effectiveness for limb lengthening of intended patient population of subject device can be determined by the device's ability to provide stability to the osteotomy site and to provide adequate force for distraction osteogenesis. The subject device is intended for use in all long bones compared to the predicate device indicated for the femur only. Differences in long bone placement present similar risks for surrounding soft tissue interaction and mechanical performance. Safety and effectiveness of the device is acceptable when used in accordance with labeling detailed to address each long bone specific anatomy. The differences between the subject device and predicate device are not critical for limb lengthening of long bones in adults, small stature adults and pediatric patients.
Additionally, the PRECICE Plate System has the same intended use as Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086) for fracture fixation.
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 Plating System is substantially equivalent to the predicates, Inter-Os Limb Lengthener (K031875) and Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086), and reference predicates PRECICE STRYDE (K180503) and Orthofix Modulsystem (K955848), 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. 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:
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Image /page/5/Picture/1 description: The image is a logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized, abstract shape on the left, which is split into two colors: purple on the top and silver on the bottom. To the right of the shape is the word "NUVASIVE" in silver, block letters. Below "NUVASIVE" is the phrase "SPECIALIZED ORTHOPEDICS, INC." in smaller, purple letters.
| Intended Use | Limb Lengthening of Long Bones | Fracture fixation of Long Bones |
|---|---|---|
| Primary | ||
| Predicate | Inter-Os Limb Lengthener | |
| (K031875) | Orthopediatrics Fracture and | |
| Osteotomy Bone Plate System | ||
| (K111086) | ||
| Reference | ||
| Device | PRECICE STRYDE (K180503) and | |
| Orthofix Modulsystem (K955848) | PRECICE STRYDE (K180503) | |
| Summary of the | ||
| technology | ||
| similarities to | ||
| the predicate | ||
| device | Principle of Operation: | |
| Distraction osteogenesis. Material Composition: | ||
| Stainless steel Similar compatible screw sizes Similar distracting plate | ||
| mechanism Intended to be removed after | ||
| bone consolidation | Principle of Operation: Fixation | |
| and osteotomy lengthening. Material Composition: Stainless | ||
| steel Similar compatible screw sizes Similar implant shape and design Non-weight bearing | ||
| Summary of the | ||
| technology | ||
| differences to | ||
| the predicate | ||
| device | The maximum stroke length for | |
| the PRECICE Plate is less than | ||
| the predicate. The PRECICE | ||
| Plate contains less screw holes | ||
| than the predicate. Use of ERC with PRECICE | ||
| Plate provides distraction of | ||
| plate non-invasively compared | ||
| to predicate device which uses | ||
| a percutaneous handle. | The PRECICE Plate has a greater | |
| profile than the predicate device. Use of ERC with PRECICE Plate | ||
| provides compression non- | ||
| invasively after index procedure | ||
| compared to predicate which can | ||
| only provide compression | ||
| through compression slots | ||
| intraoperatively. |
H. Performance Data
Nonclinical performance verification testing was performed to demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicate devices.
The PRECICE Plate System is substantially equivalent to perform limb lengthening demonstrated by preclinical testing. Safety and effectiveness was also demonstrated by engineering analysis to support substantial equivalence of the subject device to the Inter-Os Limb Lengthener (K031875), Orthofix Modulsystem (K955848) and clinical literature.
The PRECICE Plate System is substantially equivalent to perform fracture fixation demonstrated by predicate device testing of Orthopediatrics Fracture and Osteotomy Bone Plate System (K111086) to ASTM F384 and ASTM F543.
The following table describes summary testing performed and incorporated by reference from predicate devices to establish substantial equivalence:
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Image /page/6/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, sans-serif font. Below the word "NUVASIVE" is the phrase "SPECIALIZED ORTHOPEDICS, INC." in a smaller, sans-serif font.
| Testing Description | Predicate Device | Explanation of Substantial
Equivalence |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Static Compression
Bending Strength per
ASTM F384 | Orthofix Modulsystem
(K955848) and
Orthopediatrics Fracture and
Osteotomy Bone Plate System
(K111086) | Bending load on construct of subject
device performs substantially
equivalent under the same loading
conditions as predicate devices. |
| Dynamic Compression
Bending strength per
ASTM F384 | Orthofix Modulsystem
(K955848) and
Orthopediatrics Fracture and
Osteotomy Bone Plate System
(K111086) | |
| Engineering Analysis
of Bending Construct | Orthofix Modulsystem
(K955848) | Characterization of an offset
bending load of the subject device
was demonstrated to perform
substantially equivalent to the
predicate device. |
| Torque Resistance per
ASTM F543 | Orthofix Modulsystem
(K955848) and
Orthopediatrics Fracture and
Osteotomy Bone Plate System
(K111086) | Characterization of torque resistance
of subject device is substantially
equivalent to the predicate devices. |
| Axial Pullout per
ASTM F543 | Orthofix Modulsystem
(K955848) and
Orthopediatrics Fracture and
Osteotomy Bone Plate System
(K111086) | Characterization of screw pullout
force is substantially equivalent to
the predicate devices. |
| Torsion | Orthofix Modulsystem
(K955848) and PRECICE
STRYDE (K180503) | Characterization of torsional
strength of subject device is
substantially equivalent to the
predicate devices. |
| Tensile and Collapse
Strength | Inter-Os Limb Lengthener
(K031875) and Orthofix
Modulsystem (K955848) | Subject device resists tensile loads
substantially equivalent to the
predicate devices. |
| Distraction Force | PRECICE STRYDE (K180503)
and clinical literature | Distraction force is substantially
equivalent to the predicate device. |
The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.
I. Conclusions
The subject device, the PRECICE Plating System, has been shown to be substantially equivalent to the legally marketed predicate devices for its intended use.