(25 days)
Not Found
No
The device description and intended use describe a mechanical plate and screw system for fracture fixation, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a plate and screw system intended to treat fractures of various bones, which is a therapeutic purpose.
No
The device description indicates it is a plate and screw system intended to treat fractures by stabilizing bones, not to diagnose medical conditions.
No
The device description clearly states it is a "plate and screw system" made of titanium, which are physical hardware components used for bone fixation.
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 Synthes 3.0 mm PC-Fix™ is a plate and screw system intended to treat fractures of various bones. This is a surgical implant used in vivo (within the body) to stabilize bone fractures.
- Device Description: The description further reinforces this by explaining how the plate and screws are fixed to the bone to bridge and stabilize fractures.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Synthes 3.0 mm PC-Fix™ is a long bone and small bone plate and screw system, intended to treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
Product codes
HWC, HRS
Device Description
The Synthes 3.0 mm PC-FixTM is a plate and screw system. The plate shares normal weight-bearing forces/load with the fixed fractured bone. and is fixed to the bone with locking screws, bridging the fracture as it heals. The plate neutralizes most of the torsional, shear and bending forces that would otherwise be transferred to the fracture site.
This system is designed to be less invasive, as stripping of the periosteum is not recommended; reduce the risk of infection, refracture, implant failure, and loss of reduction (and subsequent complications); allow for early weight-bearing and carly implant removal; and reduce surgery time (no screw measuring, simpler procedure).
The plates are available as Straight. T-shaped, and Reconstruction in commercially pure titanium. The screws are available in titanium alloy.
The 3.0 mm PC-Fix™ plates are manufactured from commercially pure titanium, while the screws are manufactured from a titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
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)
Synthes PC-Fix
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.
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Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers '9', '8', '1', '3', '7', and '2'. The characters are written in a simple, slightly rough style, with varying stroke thicknesses.
Summary of Safety and Effectivencss Information [510(k) Summary]
SPONSOR
DEVICE
Synthes (USA) 1690 Russell Road Paoli. PA 19301 (610) 647-9700
Contact: Angela Silvestri
Bone Plate and Bone Screw COMMON OR USUAL
NAME:
CLASSIFICATION
DESCRIPTION:
Class II, 21 CFR 888.3030 and 888.3040
Synthes PC-Fix PREDICATE DEVICE:
The Synthes 3.0 mm PC-FixTM is a plate and screw system. The plate shares normal weight-bearing forces/load with the fixed fractured bone. and is fixed to the bone with locking screws, bridging the fracture as it heals. The plate neutralizes most of the torsional, shear and bending forces that would otherwise be transferred to the fracture site.
This system is designed to be less invasive, as stripping of the periosteum is not recommended; reduce the risk of infection, refracture, implant failure, and loss of reduction (and subsequent complications); allow for early weight-bearing and carly implant removal; and reduce surgery time (no screw measuring, simpler procedure).
The plates are available as Straight. T-shaped, and Reconstruction in commercially pure titanium. The screws are available in titanium alloy.
The Synthes 3.0 mm PC-Fix™ is a long bone and small bone plate and INTENDED USE: screw system, intended to treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
The 3.0 mm PC-Fix™ plates are manufactured from commercially pure MATERIAL: titanium, while the screws are manufactured from a titanium alloy.
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 resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1998
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes® 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301
Re : K981372 3.0mm PC-FIX™ System Trade Name: Requlatory Class: II Product Codes: HWC and HRS Dated: April 15, 1998 Received: April 16, 1998
Dear Ms. Silvestri:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f) (1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordinaly :
- The package insert must prominently state that the device 1. is intended for the specific use (s) described in the enclosure only; and
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Page 2 - Angela J. Silvestri
- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the If this cervical, thoracic or lumbar vertebral column. device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulatory In addition, FDA may publish further announcements action. 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of
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Page 3 - Angela J. Silvestri
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 ene regaracion chorouses, "Mirranan" (2) 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,
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| | A 100 and
40.00 |
|--|--------------------|
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K981372 |
| Device Name: | Synthes (USA) 3.0 mm PC-Fix ™ System |
Indications for use:
The Synthes 3.0 mm PC-Fix™ is a long bone and small bone plate and screw system, intended to treat fractures of various bones, including the radius, ulna, distal tibia, pelvis, clavicle, fibula, humerus, and scapula.
(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 Devices
510(k) Number K981372
Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)