(48 days)
No
The summary describes a mechanical system for bone fixation and lengthening, with no mention of AI or ML components in the device description, intended use, or performance studies.
Yes.
The device is used for fracture fixation, corrective osteotomies, pseudoarthrosis, mal-unions, limb lengthening, or bone transport of long bones, which are all therapeutic interventions.
No
Explanation: The device is indicated for fracture fixation and limb lengthening, which are therapeutic interventions, not diagnostic processes. It does not mention any function for identifying or characterizing diseases or conditions.
No
The device description explicitly lists hardware components such as the PRECICE UNYTE Nail, locking screws, end cap, 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 the fixation, osteotomies, pseudoarthrosis, mal-unions, limb lengthening, or bone transport of long bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a system of implants (nail, screws, end cap) and instruments used in surgery.
- 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 compatibility testing.
IVD devices are used outside the body to analyze biological samples. This device is an implantable surgical device used inside the body.
N/A
Intended Use / Indications for Use
The PRECICE UNYTE System is indicated for open and closed fracture fixation, corrective osteotomies, pseudoarthrosis, mal-unions, limb lengthening, or bone transport of long bones.
Product codes
HSB
Device Description
The PRECICE UNYTE System is composed of the PRECICE UNYTE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE UNYTE Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non-sterile and must be sterilized prior to use. The UNYTE Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The UNYTE Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them that resemble the wings of a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive Specialized Orthopedics, Inc. Cora Sim Associate Manager, Regulatory Affairs 101 Enterprise. Suite 100 Aliso Viejo, California 92656
August 24, 2017
Re: K172061
Trade/Device Name: PRECICE UNYTE System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 6, 2017 Received: July 7, 2017
Dear Cora Sim:
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. 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 801); medical device reporting (reporting of medical device
2
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K172061 page 1 of 2
Image /page/3/Picture/1 description: The image shows the logo for Nuvasive Specialized Orthopedics, Inc. The logo features a stylized leaf-like shape in purple and silver on the left. To the right of the shape is the company name, "NUVASIVE" in silver, with the tagline "SPECIALIZED ORTHOPEDICS, INC." in purple below it.
PRECICE UNYTE System 510(k) Summarv - K172061 August 7, 2017
-
- Company: NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656
- Contact: Cora Sim Associate Manager, Regulatory Affairs Phone: (949) 544-6478 Fax: (949) 837-3664
Date of Submission: August 7, 2017
-
- Proprietary Trade Name: PRECICE UNYTE System
- Classification Name: Intramedullary Fixation Rod (21 CFR 888.3020) 3.
-
- Product Code: HSB (Rod, Fixation, Intramedullary and Accessories)
- ട. Product Description: The PRECICE UNYTE System is composed of the PRECICE UNYTE Nail (supplied sterile), locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE UNYTE Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non-sterile and must be sterilized prior to use. The UNYTE Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The UNYTE Nail is supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques.
- Indications: The PRECICE UNYTE System is indicated for open and closed fracture fixation, 6. corrective osteotomies, pseudoarthrosis, mal-unions, limb lengthening, or bone transport of long bones.
-
- Substantial equivalence: A detailed comparison to the predicate device demonstrates that the PRECICE UNYTE System is substantially equivalent to the following 510(k) cleared device:
Trade Name: PRECICE UNYTE System (formerly called PRECICE Trauma Nail System) Common Name: Intramedullary Fixation Rod 510(k) Clearance Number: K160267
4
Image /page/4/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 partially purple and partially silver. To the right of the shape is the word "NUVASIVE" in silver, and below that is the phrase "SPECIALIZED ORTHOPEDICS, INC." in purple.
In addition, the PRECICE UNYTE System designates the following 510(k) cleared reference devices:
| Trade Name: | PRECICE Intramedullary Limb Lengthening System |
|---|---|
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K170346 |
| Trade Name: | PRECICE UNYTE CoCr System |
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K162927 |
| Trade Name: | AOS Tibial Nail System |
| Common Name: | Intramedullary Fixation Rod |
| 510(k) Clearance Number: | K130625 |
Substantial equivalence is based on indications for use, technological characteristics, and principles of operation.
The PRECICE UNYTE System subject to this 510(k) and the predicate device have similar indications for use. Specifically, both systems are indicated for open and closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones. The PRECICE Intramedullary Limb Lengthening System and PRECICE UNYTE CoCr System reference devices listed above both include limb lengthening with their indications for use. The AOS Tibial Nail System reference device includes bone transport within the indications for use. This 510(k) is intended to expand the indications of the PRECICE UNYTE System to align with the predicate and reference devices in the PRECICE family and in the same product code by including limb lengthening and bone transport.
The PRECICE UNYTE System has the same technological characteristics and the same principle of operation as that of the predicate. The design of both intramedulary nails is identical. Both devices are inserted into the intramedullary canal of the long bone and secured with locking screws. Both devices are adjusted non-invasively by the External Remote Controller (ERC).
There are no technological or performance changes to the PRECICE UNYTE Nail being made as a result of this submission, therefore all testing that was performed on the predicate PRECICE UNYTE Nail are applicable.
There are no changes to the design of the ERC being made as a result of this submission, therefore all testing that was performed on the ERC use with the predicate PRECICE UNYTE Nail System for the ERC are applicable.
Conclusions can be drawn from these tests that the PRECICE UNYTE System is substantially equivalent to the predicate device.