(34 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a bone screw, with no mention of AI or ML capabilities.
No
This device is a surgical implant (stabilization screw) used for fixation of bone fractures and reconstruction, not a device that applies therapy.
No
The device is a stabilization screw used for fixation and reconstruction of bones, which are therapeutic functions, not diagnostic.
No
The device description clearly describes a physical implantable screw made of titanium alloy, which is a hardware component, not software.
Based on the provided information, 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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The STABILIZATION SCREW is a physical implant designed for the mechanical fixation of bone fractures and reconstruction. It is surgically inserted into the body.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples, nor does it provide diagnostic information about a patient's condition based on such tests.
The description clearly indicates it's a surgical implant for structural support, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The STABILIZATION SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
- Fractures management in the foot and hand
- Fixation of bone fragments in long bones or small bones fractures
- Arthrodesis in hand, foot or ankle surgery
The size of the chosen screw should be adapted to the specific indication.
Product codes
HWC
Device Description
The STABILIZATION SCREW is a cannulated compression screw with a nonthreaded shaft, allowing optimal compression. It also has a self-tapping screw tip. It is provided in diameters 3.0 mm and 4.3 mm and in length from 10 mm to 34 mm for the 3 mm and from 22 mm to 60 mm for the 4.3 m. The STABILIZATION SCREW is made from Titanium alloy (Ti-6A1-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, hand, long bones, small bones, ankle
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)
Torsional and pullout strength tests have been carried out following the ASTM F543-02 standard (Standard Specification and Test Methods for Metallic Medical Bone Screws). 3-point bending tests have also been realized. Results have shown that mechanical properties of the STABILIZATION SCREW are equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K011262, K971070, K011821, K963172
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo consists of the word "newdeal" in a bold, sans-serif font, with a circle of five black dots to the left of the word. Below the word "newdeal" is the text "An Integra LifeSciences Company" in a smaller, italicized font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.
MAR 1 7 2005
K05034/6
510(k) SUMMARY
- Submitter's Name and Address: A.. Newdeal SA 10, place d'Helvétie 69006 LYON FRANCE Tel .: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 ESTABLISHMENT REGISTRATION NUMBER: 9615741
Contact Person: B.
Morgane GRENIER Regulatory and Clinical Affairs Manager Newdeal SA 10, place d'Helvétie 69006 LYON FRANCE Tel: +33 4 37 47 51 51 Fax: + 33 4 37 47 51 52
- Date Summary Prepared: ੋ. February 4, 2005
Name of Device: D. Proprietary Name: STABILIZATION SCREW
Common Name: Bone fixation screw
Classification Name and Reference: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Device Product Code: HWC
Proposed Regulatory Class: Class II
Panel: Orthopedic
Device Description に.
The STABILIZATION SCREW is a cannulated compression screw with a nonthreaded shaft, allowing optimal compression. It also has a self-tapping screw tip. It is provided in diameters 3.0 mm and 4.3 mm and in length from 10 mm to 34 mm for the 3 mm and from 22 mm to 60 mm for the 4.3 m. The STABILIZATION SCREW is made from Titanium alloy (Ti-6A1-4V ELI).
1
Indications for Use ド。
The STABILIZATION SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- to reconstruction: Disamples in the foot or hand (including Hallux Valgus treatment)
- Fractures management in the foot or hand ﯩ
- Fixation of bone fragments in long bones or small bones fractures "
- Arthrodesis in hand, foot or ankle surgery -
The size of the chosen screw should be adapted to the specific indication.
Substantial Equivalence ੁ.
The STABILIZATION SCREW is substantially equivalent in terms of design, material, indications for use and dimensions with the following predicate devices:
3.0 mm STABILIZATION SCREW:
| Newdeal | BOLD® screw | K011262 |
|---|---|---|
| DePuy | Scarf Thread-Head Screw | K971070 |
4.3 mm STABILIZATION SCREW:
| Newdeal | 4.0 mm I.C.O.S.® Screw | K011821 |
|---|---|---|
| Synthes | 4.5 mm Cannulated Screw | K963172 |
Comparison of Technological Characteristics H.
The technological characteristics of the STABILIZATION SCREW are the same as the characteristics of predicate devices in terms of intended use and design. All of these screws have the following characteristics:
- self-tapping ।
- cannulated
- made from Titanium alloys -
- non-threaded part allowing compression between two bone fragments -
- equivalent size range
- indicated for fixation of bone fractures or for bone reconstruction -
I. Summary of Studies
Torsional and pullout strength tests have been carried out following the ASTM F543-02 standard (Standard Specification and Test Methods for Metallic Medical Bone Screws). 3-point bending tests have also been realized. Results have shown that mechanical properties of the STABILIZATION SCREW are equivalent to the predicate devices.
J. Conclusion
The 3.0 mm STABILIZATION SCREW is substantially equivalent to the predicate devices NewDeal Bold® Screw, K011262, DePuy Scarf Thread-Head Screw, K971070, and the 4.3 mm STABILIZATION SCREW is substantially equivalent to NewDeal I.CO.S® Screw, K011821 and Synthes 4.5 mm Cannulated Screw, K963172.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
MAR 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Morgane Grenier Regulatory and Clinical Affairs Manager Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K050346
Trade/Device Name: Stabilization Screw Regulation Numbers: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HWC Dated: March 28, 2005 Received: April 27, 2005
Dear Ms.Grenier:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave icellent your becamed 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 encrosure) to togally to togens and the Medical Device American of to Commerce provision to May 20, 1978, the exactions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, therefore, market are as act include requirements for annual registration, listing of general controls provisions 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 If your device is onashined (600 as rotrols. Existing major regulations affecting your device can may be oubject to deen the code of Federal Regulations, 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 toure be active and its i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I ederal statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand byotal provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Morgane Grenier
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin markemig your artist equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, pe premarket notification. The PDA midning of backation of 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
rs the latest of the same of a cases and and any mote the rogulation entitl If you desire specific advice for your do not the control of the regulation entitled, the regulation entitled, would and contact the Office of Compliance at (210) are of 807.97). You may obtain " Misbranding by reletence to premarket noutheansment on the Division of Small other general information on your responsible at its toll-fire number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at includes html Manufacturers, International and Consulter visional of the markets http://www.fda.gov/cdrh/index.html.
Sincerely yours,
Sincerely, yours,
Mark A. Millerson
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: STABILIZATION SCREW
Indications For Use:
The STABILIZATION SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment) ﺳﮯ
- Fractures management in the foot and hand ﺴﺘ
- Fixation of bone fragments in long bones or small bones fractures -
- Arthrodesis in hand, foot or ankle surgery ।
The size of the chosen screw should be adapted to the specific indication.
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)
Mark A. Milheron
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K050846 A-001