(21 days)
No
The summary describes a mechanical device (locking screws) and its intended use with existing nail systems. There is no mention of AI, ML, image processing, or data analysis that would indicate the presence of such technology.
No
The device, T2 Locking Screws, is intended for fracture fixation and orthopaedic use, which falls under surgical or restorative treatment rather than a therapeutic device in a broader sense like electrotherapy or drug delivery.
No
The device, T2 Locking Screws, is intended for fracture fixation and orthopaedic use, not for diagnosing conditions or diseases. Its "Intended Use" clearly outlines its role in treating various types of fractures and associated conditions.
No
The device described is a physical medical device (locking screws) intended for use with other physical medical devices (femoral/tibial nails). The submission explicitly states "This submission involves no change to the components themselves." and discusses engineering analysis and testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for the fixation of bone fractures. This is a surgical implant, not a device used to examine specimens from the body.
- Device Description: The description refers to "components themselves" and their use with "Nail Systems," which are also surgical implants.
- Anatomical Site: The specified anatomical sites are "Femoral and Tibial," which are bones within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / Indications for Use
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.
Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063):
- Open and closed femoral and tibial shaft fractures .
- Pseudoarthrosis and correction osteotomies .
- Pathologic fractures and tumor resections .
- Change of procedure following external fixation .
Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601):
The Osteo R/A 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 implant .
- Nonunions and malunions ●
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
This submission involves no change to the components themselves. This submission covers use of predicate T2 Locking Screws with predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral, Tibial
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)
Engineering analysis and testing have shown that the T2 Locking Screws are similar enough to the Osteo Locking Screws to be safely used with the associated Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems
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.
K992063, K982601, K010801, K003018
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
KOII622
Special 510(k) Premarket Notification
JUN 1 5 2001
510(k) Summary: T2 Locking Screws - Use with Osteo Femoral and Tibial Nails
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: | May 24, 2001 |
| Device Identification | |
| Proprietary Name: | Osteo IC Femoral and Tibial Nails and Osteo
Retrograde/Antegrade Femoral Nails with T2
Locking Screws |
| Common Name: | Intramedullary Nails |
Classification Name and Reference: Intramedullary Fixation Rod, 21 CFR §888.3020
Predicate Device Identification
The Osteo IC Femoral and Tibial Nails (K992063) and Osteo Retrograde/Antegrade (R/A) Femoral Nails (K982601) have been determined Substantially Equivalent when used with associated Osteo IC 5.0mm diameter Locking Screws. The T2 Femoral Nails (K010801) and T2 Tibial Nails (K003018) have also been determined Substantially Equivalent when used with associated T2 5.0mm diameter Locking Screws. This submission is intended to allow use of the predicate 5.0mm diameter T2 Locking Screws with the predicate Osteo IC Femoral/Tibial Nails and Osteo R/A Femoral Nails.
Description of Device Modification
This submission involves no change to the components themselves. This submission covers use of predicate T2 Locking Screws with predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems.
Intended Use
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.
Statement of Technological Comparison:
The T2 Locking Screws are identical in materials and are similar in design to the associated locking screws originally cleared for use with the specified Osteo Nail Systems. Engineering analysis and testing have shown that the T2 Locking Screws are similar enough to the Osteo Locking Screws to be safely used with the associated Osteo IC Femoral/Tibial Nail and Osteo R/A Femoral Nail Systems
2
1
Image /page/1/Picture/12 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2001
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K011622
Trade Name: Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Regulatory Number: 888.3020 Regulatory Class: II Product Code: HSB Dated: May 24, 2001 Received: May 25, 2001
Dear Ms. Ariemma:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the stared in the encere) to the Medical Device Amendments, or to devices that have been reclassified in charentions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thorolo, mainer and 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good 099. I subblaing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mopolionist the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
2
Page 2 - Ms. Karen Ariemma
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in 1189 angliestions on the promotion and advertising of your device, (2017) 594-1037. Traditionally, for quice at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsiving the number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Signature
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 △//622
Device Name: T2 Locking Screws - Use with Osteo Femoral and Tibial Nails
The T2 Locking Screws continue to be intended for single use only. They are intended for use with the predicate Osteo IC Femoral/Tibial Nail and Osteo R/A Nail Systems and, when used with these nail systems, are subject to their specific indications.
Indications for the T2 Locking Screws when used with Osteo IC Femoral and Tibial Nails (K992063):
- Open and closed femoral and tibial shaft fractures .
- Pseudoarthrosis and correction osteotomies .
- Pathologic fractures and tumor resections .
- Change of procedure following external fixation .
Indications for the T2 Locking Screws when used with Osteo R/A Femoral Nails (K982601):
The Osteo R/A 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 implant .
- 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 OR
vision Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number 011622