(76 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of AI/ML-related components, training, or testing.
Yes
The device is a supracondylar nail system intended to provide temporary stabilization for various types of fractures and procedures in the distal femur. These functions align with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description states its purpose is to provide temporary stabilization for fractures, reconstruction, osteotomies, etc., and not for diagnosing medical conditions.
No
The device description explicitly states that the device consists of physical components like nails, screws, and a nut, all fabricated from medical-grade stainless steel. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "temporary stabilization of various types of fractures, malunions and nonunions of the distal femur". This describes a surgical implant used to treat bone fractures, which is an in-vivo procedure (performed within the living body).
- Device Description: The description details physical components like nails, screws, and nuts made from medical grade stainless steel, designed for insertion into bone. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Howmedica® SCN Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
Product codes
HSB
Device Description
The Howmedica® SCN Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, supracondylar region
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)
Zimmer's Supracondylar Intramedullary Nail, Smith & Nephew Richards' Intramedullary Supracondylar Nail
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
JUN 22 1998
510(k) Summary
Howmedica® SCN Nail Proprietary Name: IM Rod Common Name: Intramedullary Fixation Rod Classification Name & 21 CFR 888.3020 Reference: Proposed Regulatory Class: II 87HSB Device Product Code:
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Howmedica® SCN Nail consists of supracondylar nails in various diameters and lengths, cross-locking screws, condyle screws, a condyle nut and a set screw. The nails are inserted using an opened or closed retrograde technique for the intramedullary nailing of distal femoral fractures. All of the components are fabricated from medical grade stainless steel.
The Howmedica® SCN Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Zimmer's Supracondylar Intramedullary Nail and Smith & Nephew Richards' Intramedullary Supracondylar Nail.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 1998
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
K981261 Re: Howmedica® SCN Nail Trade Name: II Regulatory Class: Product Code: HSB Dated: April 6, 1998 Received: April 7, 1998
Dear Mr. Dichiara:
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 reqistration, 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlatory 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.
2
Page 2 - Mr. John F. Dichiara
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing of substantial equivalence of your device to a legally rinaing or easons device results in a classification for your marketed produces or mits 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 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., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: Howmedica® SCN Nail
Indications for Use:
The Howmedica® SCN Nail is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the distal femur including the supracondylar region. Other types of procedures include reconstruction, osteotomies, bone lengthening/shortening, prophylactic nailing of impending fractures and fusions. The condyle screw when used with the condyle nut provides good fixation in osteoporotic bone and provides compression and stabilization of the supracondylar fragments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use メ (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
bcotte
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981261