(28 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a physical implant (intramedullary nail and screws) for treating bone fractures. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an "intramedullary nail" system used to treat fractures of the proximal femur, which is a therapeutic intervention.
No
This device is an implantable system (intramedullary nail, screws) used to treat proximal femur fractures, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium alloy, such as intramedullary nails, screws, and routers, indicating it is a hardware-based medical device.
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 for treating bone fractures in the proximal femur. This is a surgical implant used directly on the patient's body.
- Device Description: The description details an intramedullary nail, screws, and other components made of titanium alloy. These are physical implants.
- 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.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.
Product codes
HSB
Device Description
The Femoral Trochanteric Nail (FTN) System consists of an intrameduliary nail, lag screw. The reviron The Fenoral Trochanterio Nail (11), Syondistal static or dynamic screws. The proximal cap Sciew, Optonal and routers offered in diameters of 10, 12, or 14 mm. The diameter is 10 min with disar diamotors one for a lag screw and one for an anti-rolational proximal portion of the nairing the now of 135°, 130° or 135°. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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
Mechanical and dynamic testing of the Alphatec FTN System was performed. The test Mcchanical and dyname the mechanical performance of the Alphatec FTN is at least comparable to, if not better than those of the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Femoral Trochanteric Nail (FTN) System 510(k) SUMMARY September 2004
Koczydo
Alphatec Manufacturing, Inc. OC1 7 - 2004 -Company: 6110 Corte Del Cedro Carlsbad, CA 92009, USA (760) 431-9286
Ellen Yarnall, Director of Regulatory Affairs II. Contact Person:
Femoral Trochanteric Nail (FTN) System III. Trade/Proprietary Name:
IV. Product Description:
The Femoral Trochanteric Nail (FTN) System consists of an intrameduliary nail, lag screw.
The reviron The Fenoral Trochanterio Nail (11), Syondistal static or dynamic screws. The proximal cap Sciew, Optonal and routers offered in diameters of 10, 12, or 14 mm. The diameter is 10 min with disar diamotors one for a lag screw and one for an anti-rolational proximal portion of the nairing the now of 135°, 130° or 135°. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI).
V. Intended Use:
The Femoral Trochanteric Nail (FTN) System is intended to treat stable and unstable rne i chorar rroomantone han (ficluding pertrochanteric fractures, intertrochanteric proximal lidettres or chanteric fractures and combinations of these fractures.
VI. Substantial Equivalence:
The FTN System is substantially equivalent to the following predicate devices:
| Trade/Proprietary Name | Manufacturer | Clearance |
|---|---|---|
| Trochanteric Nail | Depuy Orthopedics | K010780 |
| Trochanteric Nail | AOS | K021008 |
| Trochanteric Dyax™ Nail System | Howmedica Osteonics | K013524 |
VI. Performance Data:
Mechanical and dynamic testing of the Alphatec FTN System was performed. The test Mcchanical and dyname the mechanical performance of the Alphatec FTN is at least comparable to, if not better than those of the predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
Ms. Ellen A. Yarnall Director of Regulatory Affairs Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, California 92009
Re: K042440
Trade/Device Name: Femoral Trochanteric Nail (FTN) System Regulation Number: 21CFR 888. 3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 8, 2004 Received: September 9, 2004
Dear Ms. Yarnall:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) pening 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 enclosure) to regars actment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, are exactions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not requent of the general controls provisions of the Act. The I ou may, mercrore, manel alle act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is elabilitional controls. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oouv ocements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan I TCase oc advised that I DT 3 loseanse evour device complies with other requirements of the Act that 11971 has made a word regulations administered by other Federal agencies. You must or any I caeral statutes and regeraments, including, but not limited to: registration and listing (21 Comply with an the Not 270 care mans 201); good manufacturing practice requirements as set OF IC Fat 607); adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant of brovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Ellen A. Yarnall
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to ocgin harketing your acrial equivalence of your device to a legally premarket nothcation. The PDA midning of backandal or 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 Patt 801), please of If you desire specific advice ion your ac not the can and and and the regulation entitled, conlact the Office of Compullios as (210) = i Ecation" (21CFR Part 807.97). You may obtain "Misbranding by relevelec to premance notifical via act from the Division of Small other general Information on your responsion.com as and its toll-free number (800) 638-2041 or Manufacturers, International and Octosanters http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
C. Mark N. Milkerson
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
INDICATIONS FOR USE
510(k) Number (if known): 042440_
Femoral Trochanteric Nail (FTN) System________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Prescription Use
2
(Part 21 CFR 801 Subpart D)
The Alphatec Femoral Trochanteric Nail (FTN) System is intended to treat stable and The Alphotoo Pentoral Troomative femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of General, Restorative,
and Neurological Devices
510(k) Number. K042440
000013
AND/OR
Over-The Counter Use
(21 CFR 801 Subpart C)