(89 days)
Not Found
No
The summary describes mechanical fracture fixation devices and accessories, with no mention of AI or ML capabilities. The performance studies are mechanical and cadaveric, not related to algorithmic performance.
Yes.
The device is described as "fracture fixation devices comprised of femoral and tibial nails" intended to "provide temporary stabilization of various types of fractures, malunions and nonunion 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, malunions, nonunions).
No
Explanation: The device is described as a "fracture fixation device" and its intended use is to "provide temporary stabilization of various types of fractures, malunions and nonunion." This describes a treatment or fixation device, not one used for diagnosis.
No
The device description explicitly states it is a "Traditional 510(k) submission" for "fracture fixation devices comprised of femoral and tibial nails and the related accessories such as locking screws, compression screws, end caps, condyle screws, and a condyle screw nut." These are clearly physical hardware components used for surgical implantation. While it mentions "targeter devices as accessories," the overall context and the description of the nails and screws confirm it is a hardware-based medical device system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes the device as "fracture fixation devices comprised of femoral and tibial nails and the related accessories". Their intended use is to "provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia" and "femur".
- Mechanism of Action: The device works by being surgically implanted into the bone to stabilize fractures. This is a mechanical function, not a diagnostic test performed on a biological sample.
The information provided focuses on the surgical implantation and mechanical stabilization of bone fractures, which is characteristic of an orthopedic implant, not an IVD.
N/A
Intended Use / Indications for Use
These devices are fracture fixation devices comprised of femoral and tibial nails and the related accessories such as locking screws, compression screws, end caps, condyle screws, and a condyle screw nut. The S2 tibial nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The S2 femoral nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the femur.
S2 Tibial Nail: The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions 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
Product codes (comma separated list FDA assigned to the subject device)
87HSB
Device Description
This Traditional 510(k) submission is being supplied to the US FDA to include targeter devices as accessories to the S2 Nail System that was cleared under K032579.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, 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)
Non-Clinical Testing: A human cadaveric lab and mechanical tests were conducted. For the human cadaveric lab, the S2 nails were implanted using the targeter and other relevant components without any complications, demonstrating that products are performing as intended. In addition, bench testing conducted showed that the modifications made to the existing nail adapter does not introduce worst case scenario for product performance.
Clinical Testing: Clinical testing was not required for this submission.
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.
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
FEB 1 5 2012
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | S2 Nail System |
|---|---|
| Common Name: | Intramedullary Fixation Rod |
| Classification Name and Reference: | Intramedullary Fixation Rod |
| 21 CFR §888.3020 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87HSB: Rod, Fixation, Intramedullary and Accessory |
| For Information Contact: | Juma Hoshino |
| Regulatory Affairs Associate | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah. NJ 07430 | |
| Phone: (201) 831-5992; Fax (201)831-4992 | |
| Legally Marketed Devices to Which | |
| Substantial Equivalence Is Claimed: | K032579 - S2 Nail System |
| K 102992 – T2® Recon Nail System | |
| Date Prepared: | November 17, 2011 |
Description
This Traditional 510(k) submission is being supplied to the US FDA to include targeter devices as accessories to the S2 Nail System that was cleared under K032579.
Intended Use
These devices are fracture fixation devices comprised of femoral and tibial nails and the related accessories such as locking screws, compression screws, end caps, condyle screws, and a condyle screw nut. The S2 tibial nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The S2 femoral nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the femur.
Indications
S2 Tibial Nail
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions 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:
1
- 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
Summary of Technologies
The proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device. Inclusion of targeter devices as an accessory to the S2 Nail System does not alter the technology.
Non-Clinical Testing
A human cadaveric lab and mechanical tests were conducted. For the human cadaveric lab, the S2 nails were implanted using the targeter and other relevant components without any complications, demonstrating that products are performing as intended. In addition, bench testing conducted showed that the modifications made to the existing nail adapter does not introduce worst case scenario for product performance.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The S2 Nail System devices are substantially equivalent to the predicate devices identified in this premarket notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Juma Hoshino 325 Corporate Drive Mahwah, New Jersey 07430.
Re: K113409
Trade/Device Name: S2 Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 17, 2011 Received: November 18, 2011
FEB 15 2012
Dear Ms. Hoshino:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) pressure is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars) to regars and the Medical Device Americal Drug commerce prior to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that do not require approvince to the general controls provisions of the Act. The You may, therefore, market the devices, belyer to the more of registration, listing of general controls provisions of the fict labeling, and prohibitions against misbranding and devices, good manufacturing practice, not evaluate information related to contract liability adulteration. Please note: CDAT does not evaluate include ing must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc above) into time major regulations affecting your device can be may be subject to additional controls: "Entrally any of to 898. In addition, FDA may lound in the Oode of I ouch 11 concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backers with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a delerimiation that Jour as reserved by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CFK Part 807), labeling (21 CFR 803); models and manufacturing practice requirements as set
3
Page 2 - Ms. Juma Hoshino
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in alle qualisms of trovisions (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 n you active you .fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 I ou may obtain other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Mellers
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K1134096pg 1/1)
Device Name: S2 Nail System
S2 Tibial Nail
The S2 Tibial Nail is intended to provide temporary stabilization of various types of fractures, malunions 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 .
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Office of Device Evaluation (ODE)
__, and I'm sorry, I can't do that.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113409