(75 days)
Not Found
Not Found
No
The device description focuses on the mechanical components (plates, screws) and their anatomical fit, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for the treatment of nonunions, malunions, and fractures of the proximal tibia, which are medical conditions, and devices used for treatment are considered therapeutic.
No
The device is a plating system (screws and plates) used for treating fractures and malunions, not for diagnosing them.
No
The device description clearly outlines physical components like plates, screws, and a screw nut, indicating it is a hardware-based medical device for orthopedic surgery.
No, 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. These tests are performed outside of the body.
- Device Description: The provided description clearly states that the Synthes 4.5 mm Titanium LCP Proximal Tibia System consists of plates and screws intended for the surgical treatment of bone fractures and nonunions in the proximal tibia. These are implanted devices used within the body to stabilize bone.
- Intended Use: The intended use is for the treatment of specific bone conditions, not for performing diagnostic tests on biological samples.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fracture.
Product codes
HRS
Device Description
The Synthes Titanium 4.5mm LCP Proximal Tibia Plating System consists of 4.5 mm Titanium LCP Proximal Tibia Plates, 5.0 mm Titanium Cannulated Locking and Conical screws, and 4.0 mm and 5.0 mm Titanium Solid Locking screws . The Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. These are plates designed for either the right or left tibia in a variety of shaft lengths. The plate head has threaded screw holes and 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures. The plate shaft has combination screw holes (dynamic compression and locking screw holes), that accept 4.5 mm cortex, 6.5 mm cancellous, 5.0 mm cannulated locking, 5.0 mm conical, and 4.0 mm & 5.0 mm locking screws. A titanium screw nut is also utilized with this system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia
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 LCP Proximal Tibia Plating System, Synthes Large Fragment LCP T- Plate
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
JAN 2 8 2003
K023802
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 4.5 mm Titanium LCP Proximal Tibia Plating System |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone
Class II, §888.3040 - Smooth or threaded metallic bone fixation fastener |
| PREDICATE DEVICE: | Synthes LCP Proximal Tibia Plating System
Synthes Large Fragment LCP T- Plate |
| DEVICE DESCRIPTION: | The Synthes Titanium 4.5mm LCP Proximal Tibia Plating System consists
of 4.5 mm Titanium LCP Proximal Tibia Plates, 5.0 mm Titanium
Cannulated Locking and Conical screws, and 4.0 mm and 5.0 mm Titanium
Solid Locking screws .
The Tibia Plates are contoured to match the anatomy of the proximal tibia
with a limited contact low profile design. These are plates designed for
either the right or left tibia in a variety of shaft lengths. The plate head has
threaded screw holes and 2.0 mm holes for preliminary fixation with k-
wires, or meniscal repair with sutures.
The plate shaft has combination screw holes (dynamic compression and
locking screw holes), that accept 4.5 mm cortex, 6.5 mm cancellous, 5.0
mm cannulated locking, 5.0 mm conical, and 4.0 mm & 5.0 mm locking
screws.
A titanium screw nut is also utilized with this system. |
| INTENDED USE: | The Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is
intended for treatment of nonunions, malunions, and fractures of the
proximal tibia, including simple, comminuted, lateral wedge, depression
medial wedge, bicondylar, combination of lateral wedge and depression,
and fractures with associated shaft fracture. |
| MATERIAL: | Titanium |
Confidential
.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2003
Synthes (USA) Lisa M. Boyle Regulatory Associate P. O. Box 1766 1690 Russell Road Paoli, Pennsylvania 19301
Re: K023802
Trade/Device Name: Synthes 4.5 mm Titanium LCP Proximal Tibia Plating System Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 13, 2002 Received: November 14, 2002
Dear Ms. Boyle:
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. Iisting 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
2
Page 2 - Ms. Lisa M. Boyle
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. 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). Other general information on your responsibilities under the Act may be obtained 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,
O Mark A 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
2.0 Indications for Use Statement
KON3802
Page 1 of 1
| 510(k) Number (if known): | |
|---|---|
| --------------------------- | -- |
Synthes (USA) 4.5 mm Titanium LCP Proximal Tibia Plating System Device Name:
Indications/Contraindications:
The Synthes 4.5 mm Titanium LCP Proximal Tibia System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar combination of lateral wedge and depression, and fractures with associated shaft fractures.
(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 N. Melkerson
Division Sign Off
Confidential