K Number
K014220
Device Name
T2 FEMORAL NAIL SYSTEM
Date Cleared
2002-01-25

(30 days)

Product Code
Regulation Number
888.3020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The T2 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
Device Description
The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps.
More Information

Not Found

Not Found

No
The summary describes a mechanical implant for bone fracture fixation and does not mention any software, image processing, or AI/ML terms.

Yes
The device is a fracture fixation device used for treatment of femoral fractures, indicating a therapeutic purpose.

No

Explanation: The device is a T2 Femoral Nail, described as a "fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps." Its intended use is for "long bone fracture fixation," specifically femoral fracture fixation. This description clearly indicates it is a therapeutic or reconstructive device used to treat fractures, not to diagnose a condition.

No

The device description clearly states it is comprised of physical components like femoral nails, screws, and end caps, indicating it is a hardware device for fracture fixation.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description and Intended Use: The description clearly states the T2 Femoral Nail System is a "fracture fixation device" used for "long bone fracture fixation." This involves surgically implanting a device into the body to stabilize broken bones.
  • Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or providing diagnostic information based on such tests.

Therefore, based on the provided information, the T2 Femoral Nail is a surgical implant for fracture fixation, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps. The subject device is 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.

The T2 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

HSB

Device Description

The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral, femur, hip joint

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)

Not Found

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

Summary of Safety and Effectiveness JAN 2 5 2002 Device Modification to the T2 Femoral Nail System

Submission Information

Name and Address of the Sponsor of the 510(k) Submission

Contact Person:

Date of Summary Preparation: Device Identification Proprietary Name: Common Name: Classification Name and Reference:

Howmedica Osteonics Corp 59 Route 17 Allendale, NJ 07401-1677 Karen Ariemma Regulatory Affairs Specialist December 18, 2001

T2 Femoral Nail System Intramedullary Nail, Femoral Nail Intramedullary Fixation Rod, 21 CFR §888.3020

Predicate Device Identification

The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps.

Description of Device Modification

The T2 Condyle Screw and T2 Condyle Screw Nut are being modified to improve the interface between the T2 Condyle Screw and T2 Condyle Screw Nut. This submission covers use of subject T2 Condyle Screw and T2 Condyle Screw Nut with the T2 Tibial Nail. In addition, this submission covers the use of the IC End Caps and Compressions Screws with the T2 Femoral Nail.

Intended Use:

The subject T2 Femoral Nail System is a fracture fixation device comprised of femoral nails and the related locking screws, compression screws, condyle screws/nuts and end caps. The subject device is 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:

Analysis demonstrates comparable properties of the subject to the predicate device.

1

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure or a stylized flag.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2002

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401

Re: K014220 Trade/Device Name: T2 Femoral Nail System Regulation Number: 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 21, 2001 Received: December 26, 2001

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" (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.

Mark N Millman

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

Device Name: T2 Femoral Nail System

Indications for Use

The T2 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

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)
Mark A Milliken

on Sign-off sion of General, Restorative and Neurological Devices

510(k) Number -