(84 days)
Not Found
Not Found
No
The summary describes a purely mechanical device (a screw) and contains no mention of software, algorithms, image processing, AI, or ML.
No.
The device is a metallic screw used for fracture fixation, which is a structural support rather than a biological or physiological therapeutic intervention.
No
Explanation: This device is a screw used for fracture fixation, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "machined metallic screw," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fracture fixation of the pelvis as well as for periacetabular osteotomies." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "machined metallic screw." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The 3.9mm pelvic screw is indicated for fracture fixation of the pelvis as well as for periacetabular osteotomies.
Product codes
HWC
Device Description
The Synthes 3.9 mm Pelvic Screw is a machined metallic screw with a hex drive head.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
DEC 0 3 2001
.
K013044
page 1 of 1
3. Summary of Safety and Effectiveness Information
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull
(610) 647-9700 ext. 7191 |
| Name of the Device | Synthes 3.9 mm Pelvic Screw |
| Device Classification(s) | Class II, §888.3040 - Screw, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes 3.9 mm
Pelvic Screw to be substantially equivalent to other legally marketed
devices. |
| Device Description | The Synthes 3.9 mm Pelvic Screw is a machined metallic screw with a
hex drive head. |
| Indications | The 3.9mm pelvic screw is indicated for fracture fixation of the pelvis
as well as for periacetabular osteotomies. |
| Materials | Stainless Steel |
CONFIDENTIAL
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 an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Matthew M. Hull, RAC DEC 0 3 2001
Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K013044
Trade/Device Name: Synthes 3.9 mm Pelvic Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 6, 2001 Received: September 10, 2001
Dear Mr. Hull:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth in the quality systems (OS) 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 -- Mr. Matthew M. Hull, RAC
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin hankeling of substantial equivalence of your device to a legally premarket nother 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 and If you desire specific advice for your device direction of the other contact the Office of additionally 21 CFR Patt 809.10 for in Vitte different on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and abe Compliance at (301) 594-4657. Tidatorially, University, University, Also, please note the your device, prease contact and over in premarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket showly ackson the Other general information on your responsibilities under the Act may be obtained from the Other general miorination on your responsional 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,
Mark N. Milliken
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
2. Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes 3.9 mm Pelvic Screw
The 3.9mm pelvic screw is indicated for fracture fixation of the pelvis as well as for periacetabular osteotomies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
for Mark M. Melleum
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number: K013044
Synthes(USA) Synthes 3.9 mm Pelvic Screw 510(k)
CONFIDENTIAL