(55 days)
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No
The 510(k) summary describes a mechanical intramedullary nailing system for fracture stabilization. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The device description focuses on the physical components and surgical techniques.
No
The device provides temporary stabilization for fractures and other bone conditions, which is a structural support function rather than an active therapeutic action to treat a disease or condition.
No
The device is an intramedullary rod system used for temporary stabilization of fractures and other bone conditions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a system of intramedullary rods, solid femoral nails, solid tibial nails, cross-locking screws, and an optional nail plug, all fabricated from medical grade stainless steel. These are physical hardware components, not software.
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 an "intramedullary rod intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia." This describes a surgical implant used within the body to treat physical conditions.
- Device Description: The description details a physical implant (nails, screws, plug) made from medical grade stainless steel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction,bone lengthening/shortening, prophylactic nailing of impending fractures and fusions.
Product codes (comma separated list FDA assigned to the subject device)
87HSB
Device Description
This G/K line extension includes solid femoral nails (SFN) and solid tibial nails STN) which may be used with cross-locking screws for intramedullary nailing of femoral and tibial fractures, respectively. The nails can be inserted with or without reaming using an opened or closed technique. They can be locked statically or dynamically. Also, there is an optional nail plug available to prevent tissue infiltration. All of the components are fabricated from medical grade stainless steel.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femur and tibia
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
510(k) Summary
| Proprietary Name: | G/K Locking Nail 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: September 23, 1998
The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions.
This G/K line extension includes solid femoral nails (SFN) and solid tibial nails STN) which may be used with cross-locking screws for intramedullary nailing of femoral and tibial fractures, respectively. The nails can be inserted with or without reaming using an opened or closed technique. They can be locked statically or dynamically. Also, there is an optional nail plug available to prevent tissue infiltration. All of the components are fabricated from medical grade stainless steel.
The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Synthes' Universal Femoral Nail and Unreamed Tibial Nail and Orthofix's Tibial Nailing and Femoral Nailing Systems.
1
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 words "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 wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1998
Ms. Vivian Kelly Manager, Requlatory Affairs Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
Re: K983358 G/K Locking Nail Line Extension Trade Name: Regulatory Class: II Product Code: нав September 23, 1998 Dated: Received: September 24, 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 regulations.
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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,
Celia M. Witten, Ph.D.
ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: G/K Locking Nail System
Indications for Use:
The G/K Locking Nail System is a family of intramedullary rods intended to provide temporary stabilization of various types of fractures, osteotomies, malunions and nonunions of the femur and tibia. Other types of procedures include reconstruction, hone lengthening/shortening, prophylactic nailing of impending fractures and fusions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983358