(68 days)
Not Found
K/DEN: Not Found
No
The document describes a mechanical implant (intramedullary rod system) and does not mention any software, algorithms, or data processing related to AI/ML.
No
The device is an intramedullary rod system used for the temporary stabilization of bone fractures, which is a structural or supportive function rather than a therapeutic one that directly treats a disease or condition.
No
The device is an orthopedic implant (intramedullary rod system) used for stabilizing fractures, not for diagnosing diseases or conditions.
No
The device description clearly states it consists of physical components like rods, screws, and cap screws made from titanium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary stabilization of femoral fractures" and other bone procedures. This is a surgical intervention on the body, not a test performed on a sample taken from the body.
- Device Description: The description details physical implants (rods, screws, cap screws) made of titanium alloy, designed to be inserted into the intramedullary canal. This is consistent with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device described is a surgical implant used to treat bone fractures.
N/A
Intended Use / Indications for Use
The Alta® IM Rod System includes rods that are intended to provided temporary stabilization of femoral fractures. The new Alta rods are intended for use in stabilizing various types of fractures, osteotomies, malunions, and nonunions of the proximal, middle, and distal portions of the femur. TThey can be used in procedures such as femoral reconstruction, bone lengthening, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures and knee fusions. The rods are inserted into the intramedullary canal using either an antegrade or a retrograde approach.
Product codes
87HSB
Device Description
The IM rods in Alta® IM Rod System consist of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral shaft fractures. This Alta IM Rod line extension is a modification of the currently marketed Alta IM rods and screws cleared under various 510(k) notifications. These new components will retain the major design features of the previously cleared Alta IM rods and screws and will be made from titanium alloy.
The new femoral IM rods will have two anterior/posterior (A/P) proximal holes and two medial/lateral (M/L) distal holes for dynamic or static locking with cross-locking screws. The cap screws will be available in the standard, low profile and extended designs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, tibial and humeral shaft; femoral (proximal, middle, and distal portions of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Alta® IM Rod System and the Alta® CFX Reconstruction Rod, Richard'sTriMax Nail System, ACE Medical's ART™ Femoral Nail System and Biomet's Retrograde Femoral Nail.
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
K97 2108
510(k) Summary
AUG 1 2 1997
| Proprietary Name: | Alta® Intramedullary Rod System |
|---|---|
| Common Name: | IM Rod |
| Classification Name & Reference: | Intramedullary Fixation Rod |
| 21 CFR 888.3020 | |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87HSB |
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870 Date Prepared: June 4, 1997
The IM rods in Alta® IM Rod System consist of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral shaft fractures. This Alta IM Rod line extension is a modification of the currently marketed Alta IM rods and screws cleared under various 510(k) notifications. These new components will retain the major design features of the previously cleared Alta IM rods and screws and will be made from titanium alloy.
The new femoral IM rods will have two anterior/posterior (A/P) proximal holes and two medial/lateral (M/L) distal holes for dynamic or static locking with cross-locking screws. The cap screws will be available in the standard, low profile and extended designs.
The Alta® IM Rod System includes rods that are intended to provided temporary stabilization of femoral fractures. The new Alta rods are intended for use in stabilizing various types of fractures, osteotomies, malunions, and nonunions of the proximal, middle, and distal portions of the femur. They can be used in procedures such as femoral reconstruction, bone lengthening/shortening, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures and knee fusions. The rods are inserted into the intramedullary canal using either an antegrade or a retrograde approach.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to Howmedica's Alta® IM Rod System and the Alta® CFX Reconstruction Rod, Richard'sTriMax Nail System, ACE Medical's ART™ Femoral Nail System and Biomet's Retrograde Femoral Nail.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vivian M. Kelly Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
AUG 1 2 1997
K972108 Re : Alta® IM Rod Line Extension Requlatory Class: II Product Code: HSB Dated: June 4, 1997 Received: June 5, 1997
Dear Ms. Kelly:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Manufacturing 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 comply with 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 requlations.
2
Page 2 - Ms. Vivian M. Kelly
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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
CeNa M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
closure
3
510(k) Number (if known): K972108
Device Name: ALTA® IM Rod Line Extension
Indications for Use:
The Alta® IM Rod System includes rods that are intended to provided temporary stabilization of femoral fractures. The new Alta rods are intended for use in stabilizing various types of fractures, osteotomies, malunions, and nonunions of the proximal, middle, and distal portions of the femur. TThey can be used in procedures such as femoral reconstruction, bone lengthening, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures and knee fusions. The rods are inserted into the intramedullary canal using either an antegrade or a retrograde approach.
(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)
ដូរ
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Ascöello
(Division Sign-Division of General Restorative Devices 510(k) Number