(86 days)
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.
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.
This document is a 510(k) premarket notification for the Synthes Proximal Tibia Plating System. As such, it does not contain details about acceptance criteria, device performance studies, or ground truth establishment typically found in clinical trial reports or validation studies for AI/ML-driven devices.
The document primarily focuses on establishing "substantial equivalence" to predicate devices, a regulatory pathway that largely relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed device, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.
Therefore, many of the requested sections regarding acceptance criteria, study details, and ground truth are not applicable to the information provided in this 510(k) submission.
Here's an analysis of what can be extracted or inferred based on the provided text, with clear indications of what information is not present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable / Not Provided. This document does not present specific quantitative acceptance criteria or reported performance data in the way a clinical study report would for an AI/ML device. The "performance" in a 510(k) context refers to demonstrating that the device functions as intended and is substantially equivalent to existing devices, usually through mechanical testing, biocompatibility testing (if applicable), and comparison of design features and materials. No specific performance metrics against acceptance criteria are outlined in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document is not about an AI/ML device that would require test sets of data. It describes a physical medical device (bone plating system).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. This concept (ground truth established by experts for a test set) is not relevant to a 510(k) submission for a bone plating system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. This concept is not relevant to a 510(k) submission for a bone plating system.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. For a physical implant like a bone plate, "ground truth" generally refers to design specifications, material properties, and mechanical performance data, often compared against established standards or predicate devices. This document summarizes the device and its intended use, but does not detail the specific testing methodologies or "ground truth" used in its development or substantial equivalence determination.
8. The sample size for the training set
- Not Applicable / Not Provided. This document is not about an AI/ML device that would require a training set of data.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This concept is not relevant to a 510(k) submission for a bone plating system.
Summary of Device and Regulatory Status (Based on Provided Text):
- Device Name: Synthes (USA) Proximal Tibia Plating System
- Device Classification: Class II (according to the FDA letter)
- HRS Product Code: 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
- Indications for Use: 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.
- Predicates: Zimmer Periarticular Plating System, Synthes Narrow DCP, Howmedica Alta Plating System.
- Regulatory Determination: The FDA determined the device to be "substantially equivalent" to predicate devices marketed in interstate commerce prior to May 28, 1976, or to lawfully marketed predicate devices. This determination allows the sponsor to market the device.
In essence, this 510(k) document is a regulatory filing demonstrating that a new physical medical device is similar enough to existing, legally marketed devices that it does not require a full Premarket Approval (PMA) process, which would involve more extensive clinical data. The detailed studies and data requested for AI/ML devices are not typically part of a 510(k) submission for a mechanical implant.
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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.
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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.
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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
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| 1.0 | Indications for Use Statement |
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| 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
.
§ 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.