(27 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical fracture fixation device and makes no mention of AI or ML technology.
Yes
The device is a fracture fixation system intended to aid in healing bone fractures, which is a therapeutic function.
No
The device is described as a "fracture fixation device" used for "long bone fracture fixation," which aids in healing and provides "strong and stable internal fracture fixation." Its intended use and description do not mention any diagnostic capabilities.
No
The device description clearly states it is a "fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "long bone fracture fixation specifically femoral fracture fixation." This describes a surgical implant used to stabilize broken bones.
- Device Description: The device is described as a "fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps." This further confirms it's a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
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 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
This Special 510(k) submission is intended to address a material modification and a design modification of the T2" Femoral Nail System to create the subject device which is referred to as the S2 Femoral Nail System. The material modification involves changing the material from Ti-6A1-4V Allov to 316L Stainless Steel. The design change for the nail involves changing the cross section, changing the proximal and distal screw hole configuration and adding additional lengths of nails. There is no change in intended use for the modified device when compared to the previously cleared device.
The subject S2 Femoral Nail System, like the predicate T2" Femoral Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
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 Femoral Nail System to the predicate T2™ Femoral Nail System.
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
S2 Femoral Nail System: Design Modification To The T2™ Femoral Nail Sy
Special 510(k) Premarket Notification
Special 510(k) Summary: S2 Femoral Nail System
Design Modification To The T2™ Femoral Nail System
K021026
page 1 of 1
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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 Femoral Nail |
|---|---|
| Common Name: | Intramedullary Nail, Femoral Nail |
| 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" Femoral Nail System to create the subject device which is referred to as the S2 Femoral Nail System. The material modification involves changing the material from Ti-6A1-4V Allov to 316L Stainless Steel. The design change for the nail involves changing the cross section, changing the proximal and distal screw hole configuration and adding additional lengths of nails. There is no change in intended use for the modified device when compared to the previously cleared device.
Intended Use
The subject S2 Femoral Nail System, like the predicate T2" Femoral Nail System, is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, and end caps. 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:
FEA analysis and mechanical testing demonstrates the comparable mechanical properties of the subject S2 Femoral Nail System to the predicate T2™ Femoral Nail System.
1
Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
d and Drug Administrat 200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677
APR 2 5 2002
Re: K021026
Trade/Device Name: S2 Femoral 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 (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.
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 premated 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 Millum
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
Koolodk
Page 1 of
510(k) Number (if known): K
Device Name: S2 Femoral Nail System
Indications for Use
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)
| Prescription Use | X |
|---|---|
| ------------------ | --- |
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
510(k) Number -