(28 days)
Not Found
Not Found
No
The document describes a mechanical fracture fixation device and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The changes described are physical modifications to the device size and components.
Yes
This device is a fracture fixation device intended to provide strong and stable internal fracture fixation and aid in healing, directly addressing a medical condition (fractures).
No
Explanation: This device is a fracture fixation device, intended to provide internal stabilization for various types of tibial fractures. It is an aid to healing, not used for diagnosing medical conditions.
No
The device description explicitly states it is comprised of physical components like tibial nails, screws, and nuts, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the S2 Tibial Nail System is a "fracture fixation device" used for "internal fracture fixation" of the tibia. This is a surgical implant used to stabilize bone fractures.
- Device Description: The description reinforces that it's a system of physical components (nails, screws, etc.) designed for surgical 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 biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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
Product codes
HSB
Device Description
The subject S2 Tibial Nail System is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia
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)
FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
AUG 26 2002
K022481
page 1 of
Special 510(k) Summary: Line Extension to the S2 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: | July 26, 2002 |
| Device Identification | |
| Proprietary Name: | S2 Tibial Nail |
| Common Name: | Intramedullary Nail, Tibial Nail |
|---|---|
| Classification Name and Reference: | Intramedullary Fixation Rod, 21 CFR §888.3020 |
This Special 510(k) submission is intended to address a line extension to the predicate S2 Tibial Nail System. The line extension involves offering larger diameters of the nail. In addition. Condyle Screws, a Condyle Nut and an additional End Cap will be added to the system. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. 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 is a fracture fixation device comprised of tibial nails and the related locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The subject and predicate devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
Statement of Technological Comparison:
The material used to manufacture the line extension to the S2 Tibial Nail System is identical to that of the predicate. FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Tibial Nail System to the predicate devices.
1
Image /page/1/Picture/2 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
AUG 2 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corporation Karen Ariemma Regulatory Affairs Specialist 59 Route 17 Allendale, New Jersey 07401-1677
Re: K022481
Trade/Device Name: S2 Tibial Nail Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 26, 2002 Received: July 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" (21 CFR 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,
O Mark n Mullens
Celia M. 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
510(k) Number (if known): K Ox JY 8
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
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-96)
Mark H-Mather
(Division Sign-Off)
Division of General, Restorative
Neurological Devices
510(k) Number K022481