(60 days)
No
The summary describes a mechanical device for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the temporary stabilization and fixation of various types of fractures in the proximal femur, which is a therapeutic purpose.
No
The device is described as a "hip fracture system designed to treat various types of fractures of the proximal femur" and is intended for "temporary stabilization of types of fractures." This indicates a therapeutic or stabilization function, not a diagnostic one.
No
The device description explicitly states it is a "hip fracture system" and describes physical components like an "outer sleeve," "inner pin," and "end cap," fabricated from "Titanium Alloy." This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Hansson™ Pin System is a surgical implant designed to stabilize bone fractures. It is a physical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use is to provide temporary stabilization of bone fractures, which is a mechanical function, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant for orthopedic use, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Hansson" Pin System is intended for use in the temporary stabilization of various types of fractures of the proximal femur. The subject device is indicated for fixation of proximal fractures including but not limited to:
- intracapsular fractures of the femoral neck such as transcervical and subcapital neck fractures, .
- basal neck fractures, and .
- slipped capital femoral epiphysis (SCFE) in pediatric patients. .
Product codes
87 HTY
Device Description
The Hansson" Pin is a hip fracture system designed to treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson™ Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension changes have been made to the predicate device's outer sleeve to improve the deployment and removal of the inner pin. In addition, the Hansson" Pin will also be fabricated from Titanium Alloy and an end cap will be added to the product line.
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
pediatric patients (for SCFE)
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)
Reference Device(s)
ASNIS" II & III Cannulated Bone Screws
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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K033968 Page 1 of 1
510(k) PremarketNotification
| Proprietary Name: | Hansson™ Pin System |
|---|---|
| Common Name: | Hip Fracture Fixation Device |
| Classification Name and Reference | Smooth or Threaded Metallic Bone Fixation Fastener |
| 21 CFR §888.3040 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 HTY: Pin, Fixation, Smooth |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist |
| Howmedica Ostconics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | 12/18/03 |
510(k) Summary for the Hansson™ PinSystem Line Extension
Description:
The Hansson" Pin is a hip fracture system designed to treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson™ Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension changes have been made to the predicate device's outer sleeve to improve the deployment and removal of the inner pin. In addition, the Hansson" Pin will also be fabricated from Titanium Alloy and an end cap will be added to the product line.
Intended Use:
The Hansson" Pin System is intended for use in the temporary stabilization of various types of fractures of the proximal femur. The subject device is indicated for fixation of proximal fractures including but not limited to:
- intracapsular fractures of the femoral neck such as transcervical and subcapital neck fractures, .
- basal neck fractures, and .
- slipped capital femoral epiphysis (SCFE) in pediatric patients. .
Substantial Equivalence:
The design and function of the Hansson" Pin are substantially equivalent to that of the predicate devices. Both the subject and predicate Hansson" Pin Systems offer pins in varying lengths while the ASNIS" II & III Cannulated Bone Screws are indicated for the fixation of Slipped Capital Femoral Epiphysis.
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 stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the bird symbol placed in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K033968
Trade/Device Name: Hansson" Pin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HTY Dated: December 18, 2003 Received: December 22, 2003
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device 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 encrosals) to regary and the Medical Device Amendments, or to commerce pror to may 20, 1978, the encordance with the provisions of the Federal Food, Drug, de vices that have been rochasined in quire approval of a premarket approval application (PMA). and Cosmeter For (110) the envice, subject to the general controls provisions of the Act. The r ou may, dicierore, mance of the Act include requirements for annual registration, listing of general controls provision practice, 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 n your de rice to such additional controls. Existing major regulations affecting your device can may be subject to bach address legulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r head be aar made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Mulkerson
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
510(k) Number (if known): K033968
Device Name: Hansson™ Pin System
Intended Use
The Hansson™ Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to:
- Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck . Fractures
- Basal Neck Fractures .
- Slipped Capital Femoral Epiphysis (in pediatric patients) .
| Prescription Use. | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K033968