(188 days)
Not Found
No
The 510(k) summary describes a mechanical implant system (nails and screws) for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is indicated for fixation of fractures and uses nails and screws to provide structural support, which is a therapeutic intervention aimed at treating injuries.
No
The device is described as an IM nail system for fixation of fractures, not for diagnosing them. It is used to stabilize bones, not to provide diagnostic information.
No
The device description explicitly details physical components (nails and screws made of stainless steel or titanium) and mentions performance studies involving mechanical testing (bend tests, torsion tests), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for the fixation of fractures in bones. This is a surgical implant used directly on the patient's body.
- Device Description: The description details surgical nails and screws made of surgical grade materials, intended for implantation.
- 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 in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.
Product codes
HSB
Device Description
The Renovo Life Small Bone IM Nail System nails are available in diameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm and either solid or cannulated and materials are surgical grade stainless steel or titanium. Renovo Life Screws are 3.5 mm in diameter and are available in lengths from 10mm to 34 mm in materials of surgical grade stainless steel or titanium. The Renovo Life Small Bone IM Nail System is provided non-sterile and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula, radius, and ulna, upper extremity fractures, lower extremity fractures, metaphyseal fractures, radial neck fractures, carpal and tarsal bones.
Indicated Patient Age Range
all patients (for upper extremity fractures), small-stature patients (for lower extremity fractures)
Intended User / Care Setting
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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
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Summary of Performance Studies
The Renovo Life Small Bone IM Nail System has undergone comparative testing with a predicate device conducted as per ASTM 1264-14, a cadaveric implant trial and a rotational resistance test. The test data showed the Renovo Life Small Bone IM Nail was substantially equivalent to the predicate device in a static and dynamic four-point bend tests, static torsion test and compliance tests, as described herein.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2016
Renovo Life LLC % Mr. Donald Guthner Regulatory Consultant Orgenix, LLC 111 Hill Road Douglassville, Pennsylvania 19518
Re: K161254
Trade/Device Name: Renovo Life Small Bone IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 11, 2016 Received: October 12, 2016
Dear Mr. Guthner:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161254
Device Name Renovo Life Small Bone IM Nail System
Indications for Use (Describe)
The Renovo Life Small Bone IM Nail System is indicated for fixation of fractures where the canal is narrow or flexibility of the implant is paramount, including the fibula, radius, and ulna, upper extremity fractures in all patients and lower extremity fractures in small-stature patients. This system is also intended to treat metaphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones.
| 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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510(k) Summary
| Manufacturer: | Renovo Life LLC
1104 Spruce Street
Belmont, NC 28012 |
|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | October 10, 2016 |
| Submitted by: | Renovo Life LLC |
| Company Contact | Harold Crowder
+1(704) 224-4136
hcrowder@renovolife.com |
| US Agent Information
Official Correspondent | Orgenix LLC
Mr. Donald W. Guthner
111 Hill Road
Douglassville, PA 19518
+1-646-460-2984
+1-484-363-5879 (FAX)
dg@orgenix.com |
| Proprietary Name: | Renovo Life Small Bone IM Nail System |
| Performance standards: | The Renovo Life Small Bone IM Nail System is made of surgical grade
stainless steel conforming to ASTM F138 or surgical grade Titanium
alloy conforming to ASTM F136. |
| Regulation:
Common/Usual Name:
Classification name:
Review Panel:
Product Code:
Device Class: | 21 CFR 888.3020
Rod, Fixation, Intramedullary and Accessories
Intramedullary Fixation Rod
Orthopedic
HSB
Class II |
| Substantial Equivalence: | Substantial equivalence for the Renovo Life Small Bone IM Nail
Systems is based on its similarities in indications for use, design features,
operational principles and material composition when compared to the
predicate devices. |
| Predicate Devices: | K043185 Synthes Cortex ScrewK081452 Synthes Stainless Steel Elastic Intramedullary Nail SystemK143276 Accumed Small Bone IM Nail System |
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The subject device is substantially equivalent to similar previously cleared devices.
| Device Description: | The Renovo Life Small Bone IM Nail System nails are available in
diameters ranging from 2.5 mm to 4.5 mm with a length of 150 mm and
either solid or cannulated and materials are surgical grade stainless steel
or titanium.
Renovo Life Screws are 3.5 mm in diameter and are available in lengths
from 10mm to 34 mm in materials of surgical grade stainless steel or
titanium.
The Renovo Life Small Bone IM Nail System is provided non-sterile and
are intended for single use only. |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Renovo Life Small Bone IM Nail System is indicated for fixation of
fractures where the canal is narrow or flexibility of the implant is
paramount, including the fibula, radius, and ulna, upper extremity
fractures in all patients and lower extremity fractures in small-stature
patients. This system is also intended to treat metaphyseal and epiphyseal
fractures, such as radial neck fractures and is intended for fixation of small
long bones, such as carpal and tarsal bones. |
| Summary of Technological
Characteristics | The Renovo Life Small Bone IM Nail System designed for fixation of
stable and unstable fractures in the fibula, radius and ulna. |
| Non-Clinical Testing | The Renovo Life Small Bone IM Nail System has undergone comparative
testing with a predicate device conducted as per ASTM 1264-14, a
cadaveric implant trial and a rotational resistance test. The test data
showed the Renovo Life Small Bone IM Nail was substantially equivalent
to the predicate device in a static and dynamic four-point bend tests, static
torsion test and compliance tests, as described herein. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Renovo Life Small Bone IM Nail Systems have the same intended use
and similar indications, principles of operation, and technological
characteristics as the predicate devices.
Thus, the Renovo Life Small Bone IM Nail Systems are substantially
equivalent to the predicate devices. |