(86 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, washers) and their materials, 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 non-unions, malunions, and fractures of the proximal tibia, which indicates it is used to treat or manage a medical condition.
No
The device description indicates it is a plating system for treating fractures (non-unions, malunions, and fractures), which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of physical components (plates and a washer) made of stainless steel, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that the Proximal Tibia Plating System consists of plates, washers, and screws made of stainless steel. These are physical implants used to stabilize and fix bones.
- Intended Use: The intended use is for treating fractures, non-unions, and malunions of the proximal tibia. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for orthopedic procedures, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Proximal Tibia Plating System is intended for 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
HRS
Device Description
The Proximal Tibia Plating System consists of 3.5 mm and 4.5 mm Plates and a 3.5/4.5 mm Washer. The plates are anatomically contoured; feature a low profile, limited contact design, and are available in right and left versions. The heads of the plates include holes for K-wires or sutures, if necessary. The 3.5 mm Plates are used with 3.5 mm cortex, 4.0 mm cancellous, and 4.5 mm cannulated screws. The 4.5 mm Plates are used with 4.5 mm cortex, 6.5 mm cancellous, 7.0 mm and 7.3 mm cannulated screws. When used with the 3.5/4.5 washer, the 4.5 mm Plates can also be used with all of the screws that fit the 3.5 plates; the washer prevents the screw head from pulling through the plate holes. This device system is manufactured from stainless steel.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K983787, Zimmer Periarticular Plating System, Synthes Narrow DCP, Howmedica Alta Plating 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
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. The logo and the word "SYNTHES" are the only elements in the image, and they are the main focus.
Image /page/0/Picture/1 description: The image contains a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '9', '8', '3', '7', '8', and '7'. The numbers are written in a connected manner, with some variations in stroke thickness.
Summary of Safety and Effectiveness Information
SPONSOR:
- Synthes (USA) 1690 Russell Road Paoli, PA 19301
(610) 647-9700
Angela Silvestri
CONTACT:
Synthes Proximal Tibia Plating Syste n DEVICE NAME:
21 CFR 888.3030 Single/multiple component metallic bone fixation DEVICE CLASSIFICATION: appliances and accessories.
Zimmer Periarticular Plating System PREDICATE DEVICE: Synthes Narrow DCP Howmedica Alta Plating System
The Proximal Tibia Plating System consists of 3.5 mm and 4.5 mm DESCRIPTION OF DEVICE: Plates and a 3.5/4.5 mm Washer. The plates are anatomically contoured; feature a low profile, limited contact design, and are available in right and left versions. The heads of the plates include holes for K-wires or sutures, if necessary. The 3.5 mm Plates are used with 3.5 mm cortex, 4.0 mm cancellous, and 4.5 mm cannulated screws. The 4.5 mm Plates are used with 4.5 mm cortex, 6.5 mm cancellous, 7.0 mm and 7.3 mm cannulated screws. When used with the 3.5/4.5 washer, the 4.5 mm Plates can also be used with all of the screws that fit the 3.5 plates; the washer prevents the screw head from pulling through the plate holes. This device system is manufactured from stainless steel.
This device system is manufactured from stainless steel.
The Proximal Tibia Plating System is intended for non-unions, INDICATIONS: 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.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPT. OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 1999
Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
K983787 Re: Synthes (USA) Proximal Tibia Plating System Trade Name: Regulatory Class: II HRS Product Code: 1998 Dated: October 26, Received: October 27, 1998
Dear Ms. Silvestri:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceee. above and we have determined the market the device ferenced above indications for device is substantially equivalier (ises marketed in interstate
use stated in the enclosure) to devices marketed of the use stated in the cherobate, or the enactment date of the commerce prior co nay 207 - to devices that have been Medical Device Amendments, or to acvisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, rood, Drug, and Coometic not (1.00) general controls provisions The general controls provisions of the Act of the Act. of the Act. The general onnual registration, listing of Inclade requirementscturing practice, labeling, and devices, good manazactures and adulteration.
If your device is classified (see above) into either class II II your device IS Crabbirla (se(Premarket Approval), it may (Special Controls) additional controls. Existing major be subject to such addisur device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, int determination assumes compliance with SubStantially Cquiries uring Practice requirement, as set the Current System Regulation (QS) for Medical Forch In the gail regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug chrough periodio (FDA) will verify such assumptions. Failure to Administration (rin) 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 chis response on fight have under sections 531 through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Ms. Angela J. Silvestri
This letter will allow you to begin marketing your device as This recei will arrowk) premarket notification. The FDA described in your 510(x) premaince of your device to a legally
finding of substantial equivalence of your device for your finding of substancial equivalio or a classification for your marketed predicate device rebares in a sproceed to the market.
If you desire specific advice for your device on our labeling II you desire Specific and additionally 809.10 for in regulation (21 ordevices), please contact the Office of vitro diagnostic devices), prease conculty, for questions on Compliance at (301) 354 4657. from device, please contact the promotion and advertising or jour 4639. Also, please note the regulation entitled, "Misbranding by reference to Other general premation on your responsibilities under the Act may be Information on your responsof Small Manufacturers Assistance oblained from the bivibion or (800) 638-2041 or (301) 443-6597 or at at Its Coll-free namber (63)/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
2
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a figure inside. A registered trademark symbol is located to the right of the word.
| 1.0 | Indications for Use Statement |
|---|---|
| ------------ | -------------------------------------- |
| Page | 1 | of | 1 | |
|---|---|---|---|---|
| 510(k) Number (if known): | K983787 | |||
| Device Name: | Synthes (USA) Proximal Tibia Plating System | |||
| Indications for use: | ||||
| The Proximal Tibia Plating System is intended for 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
bcoee
(Division Si n-Off) (Division of Ceneral Restorative Devices 510(k) Number
Proximal Tibia Plating System 510(k) Synthes (USA)
Confidential
.