(8 days)
Not Found
Not Found
No
The description focuses on the mechanical components and intended use for fracture fixation, with no mention of AI or ML capabilities.
Yes
The device is described as a "fracture fixation device" and its intended use is to "provide strong and stable internal fracture fixation" and act as "an aid to healing" for various types of fractures and nonunions of the tibia and femur. This directly aligns with the definition of a therapeutic device, as it is used to treat or alleviate a medical condition (fractures).
No
The device is a fracture fixation system (nails and accessories) used to aid in healing of fractures, not to diagnose them.
No
The device description explicitly states it is comprised of physical components like femoral and tibial nails, washers, screws, and nuts, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "fracture fixation device" used to "provide strong and stable internal fracture fixation" of the tibia and femur. This is a surgical implant used in vivo (within the body) to treat a physical condition (fractures).
- Device Description: The description confirms it's a system of nails, screws, and other components 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 samples, 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 a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The subject S2 Nail System is a fracture fixation device comprised of femoral and tibial nails and the related accessories such as washers, 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 of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue.
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
The S2 Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures ●
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension .
- . Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty ●
- Fractures distal to a hip joint ●
- Nonunions and malunions .
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The S2 Nail System is a fracture fixation device comprised of femoral and tibial nails and the related accessories such as washers, locking screws, compression screws, end caps, condyle screws and a condyle screw nut. The line extension involves design modifications to the femoral and tibial nails with additional diameters plus additional accessories. The material used to manufacture the line extension to the S2 Nail System is identical to that of the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia and femur
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 Nail System to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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).
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
KO 32579
Special 510(k) Premarket Notification
S2 Nail System Line Extension AUG 2 9 2003
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: | Vivian Kelly |
Regulatory Affairs Consultant | |
Date of Summary Preparation: | August 20, 2003 |
Device Identification | |
Proprietary Name: | S2 Nail System |
Common Name: | Intramedullary 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 Nail System. The line extension involves design modifications to the femoral and tibial nails with additional diameters plus additional accessories. There is no change in intended use for the modified device when compared to the previously cleared device.
Intended Use
The subject S2 Nail System is a fracture fixation device comprised of femoral and tibial nails and the related accessories such as washers, 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 of the tibia and femur. 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 Nail System is identical to that of the predicate. FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Nail System to the predicate devices.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is positioned in the center of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2003
Ms. Vivian Kelly Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
Re: K032579
Trade/Device Name: S2 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: August 20, 2003 Received: August 21, 2003
Dear Ms Kelly:
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. Vivian Kelly
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Mark N Millenn
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): K032579
Device Name: S2 Nail System
S2 Tibial Nail
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
S2 Femoral Nail
The S2 Femoral Nail is indicated for long bone fracture fixation, specifically femoral fracture fixation, which may include the following:
- Open and closed femoral fractures ●
- Pseudoarthrosis and correction osteotomy .
- Pathologic fractures, impending pathologic fractures, and tumor resections .
- Supracondylar fractures, including those with intra-articular extension .
- . Ipsilateral femur fractures
- Fractures proximal to a total knee arthroplasty ●
- Fractures distal to a hip joint ●
- Nonunions and malunions .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Miller
(Division Sign Off)
ivision of General. Restorative and Neurological Devices
Prescription Use
510(k) Number K052571
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)