(27 days)
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No
The document describes a mechanical implant for fracture fixation and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as a "fracture fixation device" and its intended use is to "provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia," which directly addresses a health condition.
No
Explanation: The S2 Tibial Nail System is described as a fracture fixation device intended to provide temporary stabilization for various types of fractures, malunion, and nonunion of the tibia. Its purpose is treatment and stabilization, not the diagnosis of a condition.
No
The device description explicitly states it is comprised of "tibial nails and the related locking screws, compression screws and end caps," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The S2 Tibial Nail is a fracture fixation device implanted into the tibia to stabilize fractures. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to provide temporary stabilization of fractures, not to diagnose or monitor a medical condition through the analysis of biological specimens.
The information provided clearly describes a surgical implant used for orthopedic purposes, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The S2 Tibial Nail System, like the predicate T2™Tibial Nail System, is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws and end caps. The S2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be static, dynamical and compression locked.
The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- . Open and closed tibial fractures
- . Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- . Nonunion and malunion
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This Special 510(k) submission is intended to address a material modification and a design modification of the T2" Tibial Nail System to create the subject device which is referred to as the S2 Tibial Nail System. The material modification involves changing the material from Ti-6Al-4V Alloy to 316L Stainless Steel. The design change for the nail involves changing the cross section, bend angle location and proximal screw hole configuration. There is no change in intended use for the modified device when compared to the previously cleared device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tibia
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate T2™ Tibial Nail System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
APR 2 5 2002
Special 510(k) Summary: S2 Tibial Nail System: Design Modification to the T2™ Tibial Nail System
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677
Contact Person:
Karen Ariemma Regulatory Affairs Specialist
Date of Summary Preparation:
March 28, 2002
Device Identification
Proprietary Name: S2 Tibial Nail Intramedullary Nail, Tibial Nail Common Name: Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020
This Special 510(k) submission is intended to address a material modification and a design modification of the T2" Tibial Nail System to create the subject device which is referred to as the S2 Tibial Nail System. The material modification involves changing the material from Ti-6Al-4V Alloy to 316L Stainless Steel. The design change for the nail involves changing the cross section, bend angle location and proximal screw hole configuration. There is no change in intended use for the modified device when compared to the previously cleared device.
Intended Use
The subject S2 Tibial Nail System, like the predicate T2™Tibial Nail System, is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws and end caps. The S2 Tibial Locking Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be static, dynamical and compression locked.
Statement of Technological Comparison:
FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate T2™ Tibial Nail System.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 to the right, stacked on top of each other.
Public Health Service
APR 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K021027
Trade/Device Name: S2 Tibial Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: March 28, 2002 Received: March 29, 2002
Dear Ms. Ariemma:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark n Melluso
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
O2100 1 510(k) Number (if known): K
Device Name: S2 Tibial Nail System
Indications For Use:
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compression locked.
The S2 Tibial Nail System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- . Open and closed tibial fractures
- . Pseudoarthrosis and correction osteotomy
- . Pathologic fractures, impending pathologic fractures, and tumor resections
- . Nonunion and malunion
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
for Manh N Melhemor
(Division Sign-Off
theses
General, Restorative and Neurological Devices
510(k) Number K021027