(49 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for fracture fixation and makes no mention of AI or ML capabilities.
Yes
The device is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur, which are therapeutic interventions.
No
The device is an intramedullary rod system used for stabilizing fractures, osteotomies, malunions, and nonunions of bones. Its purpose is therapeutic (stabilization), not diagnostic (identifying or characterizing a medical condition).
No
The device description explicitly states it consists of "curved, fluted rods, cross-locking screws and cap screws," which are physical hardware components used for intramedullary nailing.
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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a system of rods, screws, and cap screws intended for the surgical stabilization of bone fractures (femoral, tibial, and humeral). This is a surgical implant, not a device used for testing biological samples.
- Intended Use: The intended use is to stabilize fractures, osteotomies, malunions, and nonunions of bones. This is a therapeutic and structural function, not a diagnostic one.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Alta IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.
Product codes
HSB
Device Description
The Alta IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.
This submission is a modification of the currently marketed Alta IM rods and cap screws cleared under various 510(k) notifications. The new femoral IM rods will have proximal and distal holes for dynamic or static locking. There will also be a dynamic slot design for dynamic locking. They will be available in various configurations including round and fluted designs, solid or cannulated rods in diameters ranging from 9mm to 14 mm in various lengths. A new cap screw will be available with extended ends. These new components will be used with cross-locking screws and other rod components previously cleared under different premarket notifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, tibial and humeral fractures; 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)
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
SEP 1 4 1998
510(k) Summary
Proprietary Name: Common Name: Classification Name & Reference: Regulatory Class: Device Product Code: Retrograde Rod System IM Rod Intramedullary Fixation Rod 21 CFR 888.3020 ー 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:
July 24, 1998
The Alta® IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.
This submission is a modification of the currently marketed Alta IM rods and cap screws cleared under various 510(k) notifications. The new femoral IM rods will have proximal and distal holes for dynamic or static locking. There will also be a dynamic slot design for dynamic locking. They will be available in various configurations including round and fluted designs, solid or cannulated rods in diameters ranging from 9mm to 14 mm in various lengths. A new cap screw will be available with extended ends. These new components will be used with cross-locking screws and other rod components previously cleared under different premarket notifications.
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, Synthes' Ti DFN System, and ACE Medical's ART™ Femoral Nail System.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Ms. Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K982602 Trade Name: ALTA® A-P Rod Modification Requlatory Class: II Product Code: HSB July 24, 1998 Dated: Received: July 27, 1998
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, Druq, 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 aqainst 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. ਸ਼ੇ 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 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,
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: ALTA® A-P ROD MODIFICATION
Indications for Use:
The Alta® IM Rod System consists of a family of curved, fluted rods, cross-locking screws and cap screws for intramedullary nailing of femoral, tibial and humeral fractures. The new Retrograde Rod is intended for stabilizing various types of fractures, osteotomies, malunions, and nonunions of the femur. The rods can be inserted with or without reaming and can be statically or dynamically locked.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Division Sign-Off)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K982602