(45 days)
Not Found
No
The device description and intended use are purely mechanical, describing a bone plate and its application. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is an orthopedic plate used to treat fractures and non-unions of the proximal tibia, which is a structural support device, not a therapeutic device that administers therapy or treatment.
No
Explanation: This device is an orthopedic implant (plate) used for treating fractures and non-unions of the tibia. It is a treatment device, not a diagnostic one.
No
The device description clearly describes a physical implant (plate) made of metal, intended for surgical implantation to treat bone fractures. This is a hardware device, not software.
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.
- Device Description: The description clearly states that the Synthes LCP Proximal Tibia Plate is a physical implant designed to treat fractures and non-unions of the proximal tibia. It is a surgical device, not a diagnostic test.
- Intended Use: The intended use is for the surgical treatment of bone fractures and related conditions, not for analyzing biological samples.
The information provided describes a surgical implant, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Synthes LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Synthes LCP Proximal Tibia Plates are contoured to match the anatomy of the proximal tibia with a limited contact low profile design. There are plates designed for either the right or left tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plates are available in a variety of lengths. The locking screw holes accept both cannulated locking and conical screws. Two proximal round holes accept cortex screws, cancellous screws, or cannulated screws. The distal portion of the plate has combination dynamic compression locking screw holes that allow the option of using locking screws, cortex screws, or cannulated screws.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
.
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 LCP Proximal Tibia Plate |
| Device Classification | Class II, §888.3030 - Plate, Fixation, Bone, Non-spinal, Metallic |
| Predicate Device | - Synthes Locking Proximal Tibia Plate (K002361) |
| Device Description | The Synthes LCP Proximal Tibia Plates are contoured to match the
anatomy of the proximal tibia with a limited contact low profile
design. There are plates designed for either the right or left tibia in a
variety of shaft lengths. These plates will be available in both 3.5 mm
and 4.5 mm versions. The plates are available in a variety of lengths.
The locking screw holes accept both cannulated locking and conical
screws. Two proximal round holes accept cortex screws, cancellous
screws, or cannulated screws. The distal portion of the plate has
combination dynamic compression locking screw holes that allow the
option of using locking screws, cortex screws, or cannulated screws. |
| Indications | Synthes LCP Proximal Tibia Plate is intended treatment of non-
unions, malunions, and fractures of the proximal tibia, including
simple, comminuted, lateral wedge, depression, medial wedge,
bicondylar, combinations of lateral wedge and depression, and
fractures with associated shaft fractures. |
| Materials | 316L Stainless Steel |
.
CONFIDENTIAL
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and head facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2001
Mr. Matthew M. Hull Senior Requlatory Specialist Synthes (USA) 1690 Russell Road 19301 Paoli, Pennsylvania
K011978 Re: Synthes LCP Proximal Tibia Plate Trade/Device Name: 888.3030 Requlation Number: Requlatory Class: II Product Code: HRS Dated: June 20, 2001 Received: June 25, 2001
Dear Mr. Hull:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beooed above and we have determined the market the acreatially equivalent (for the indications for device in babbeanorariasure) to legally marketed predicate use stated in the enorobation in the commerce prior to May 28, 1976, devices marketed in the Medical Device Amendments, or to che enacement accomment as ified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual provisions or 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 (Premarket Approval), it may (Special Concreat additional controls. Existing major be Subject to back adaments on be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with bubbeancially ogamanufacturing Practice requirements, 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 enrough polion (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
2
Page 2 - Mr. Hull
concerning your device in the Federal Register. Please note: concerning your device remarket notification submission does chis response to your pro you might have under sections 531 noc arrest any oble for devices under the Electronic through 542 or the noorol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as Inis receir will arrow ) premarket notification. The FDA described in your six (i) provilence of your device to a legally rinding of babban device results in a classification for your marketca predicate acits your device to proceed to the market.
If you desire specific advice for your device on our labeling If you debire books on and additionally 809.10 for in regulacion (in (i' c devices) , please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on comprimee at (501) devertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Obtained From one 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,
McWheeon to
Celia M. Witten, Ph.D., M.D. Director Division of General Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
3
Indications for Use Statement 2.
Page 1 of 1
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes LCP Proximal Tibia Plate
Synthes LCP Proximal Tibia Plate is intended treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations 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_
Dsmhlllelllrwopina
(Division Si Division of General, Restorative and Neurological Devices
Synthes(USA) Synthes LCP Proximal Tibia Plates 510(k)
CONFIDENTIAL
510(k) Num
00004