(74 days)
Synthes (USA) Small Fragment DCL System, Synthes (USA) Large Fragment DCL System
Not Found
No
The device description focuses on the mechanical properties and design of a bone plate and screws, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is an orthopedic implant for bone fixation, which is a structural support device rather than one that delivers therapy (e.g., drug, radiation, electrical stimulation).
No
This device is a surgical plate used for the mechanical fixation of bones, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable plate and associated screws, which are hardware components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of various long bones". This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implantable device (a plate and screws) used for bone fixation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided describes a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.
Product codes
LXT
Device Description
The Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable to match the anatomy, have a limited contact design, and are tapered at the plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination dynamic compression / locking screws holes (combi-holes). The plates in this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for preliminary fixation with k-wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various long bones, excluding the femur
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)
Synthes (USA) Small Fragment DCL System, Synthes (USA) Large Fragment DCL System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
FEB 2 0 2004
K033805
page 1 of 1
Summary of Safety and Effectiveness Information 3.0
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) Small Fragment DCL System
Synthes (USA) Large Fragment DCL System |
| DEVICE DESCRIPTION: | The Synthes (USA) 3.5 / 4.5 mm LCP® Metaphyseal Plates are contourable
to match the anatomy, have a limited contact design, and are tapered at the
plate head. The 3.5 / 4.5 mm metaphyseal plates feature combination
dynamic compression / locking screws holes (combi-holes). The plates in
this system accept 3.5 / 4.5 mm cortex, 3.5, 4.0, & 5.0 mm locking, and 4.0
mm or 6.5 mm cancellous screws. The plate also has a 2.0 mm hole for
preliminary fixation with k-wires. |
| INTENDED USE: | The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for
the fixation of various long bones, excluding the femur. It is also for use in
fixation of osteopenic bone and fixation of nonunions or malunions. |
| SUBSTANTIAL
EQUIVALENCE | Comparative information presented supports substantial equivalence. |
| MATERIAL: | Titanium and 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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K033805
Trade/Device Name: Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: December 4, 2003 Received: December 8, 2003
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beater 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 surfed in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prior to May 2017 7 3) in accordance with the provisions of the Federal Food, Drug, devices that have occh reactered require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mainer of the 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 may be subject to such additional controls. Existing major regulations affecting your device can may or subject to back week Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Plcase be advised that FDA's issuance of a substantial equivalence determination does not mean r 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CHR 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Lisa M. Boyle
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,
Mark N. Wilkerson
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
Indications for Use Statement 2.0
:
| 510(k) Number (if known): | K033805 |
|---|---|
| Device Name: | Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate |
Page __ 1 ______ of __________________________________________________________________________________________________________________________________________________________
Indications/Contraindications:
The Synthes (USA) 3.5 / 4.5mm LCP® Metaphyseal Plate is intended for the fixation of various longs The Synthes (USA) 2.5 / 4.5 min LCC - Mccapity scar Rate is meeting bone and fixation of nonunions or malunions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use_ |
|---|---|---|---|
| (Per 21 CFR 801.109) |
for Mark N Milkusm
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K033805
Confidential
·