(43 days)
The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.
The Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates are contoured to match the anatomy of the medial proximal tibia with a limited contact low profile design. The plates are designed for either the right or left medial proximal tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plate head exhibits 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures.
The provided document is a 510(k) premarket notification for a medical device, the Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove safety and effectiveness.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it would be relevant for a new device requiring de novo authorization or a PMA (Premarket Approval) application.
Here's a breakdown of why the requested information isn't present in this 510(k) submission:
- Acceptance Criteria and Reported Device Performance: This document establishes substantial equivalence by comparing the new device's features, intended use, and materials to a predicate device. It doesn't set specific performance acceptance criteria for a new study.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth, Training Set Sample Size, and Ground Truth for Training Set: These are all elements of a clinical or technical performance study, which are generally not required for a 510(k) submission unless there's a significant difference from the predicate that necessitates new data. The 510(k) process relies on the established safety and effectiveness of the predicate device.
To summarize, based solely on the provided K050646 document:
The document describes a 510(k) submission for the Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates. The purpose of this submission is to demonstrate "substantial equivalence" to a predicate device, not to present new clinical data proving specific performance acceptance criteria. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth methodologies is not available within this regulatory filing.
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APR 2 6 2005
Summary of Safety and Effectiveness Information 3.0
Page 1 of 1
| SPONSOR: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19308 19380(610) 719-5000 |
|---|---|
| DEVICE NAME: | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates |
| DEVICE DESCRIPTION: | The Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates are contoured to match the anatomy of the medial proximal tibia with a limited contact low profile design. The plates are designed for either the right or left medial proximal tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plate head exhibits 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures. |
| INTENDED USE: | The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies. |
| SUBSTANTIAL EQUIVALENCE | Comparative information presented supports substantial equivalence. |
| MATERIAL: | Titanium and Stainless Steel |
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Image /page/1/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
APR 2 € 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K050646
Trade/Device Name: Synthes (USA) 3.5/ 4.5mm LCP® Medial Proximal Tibia Plates Regulation Number: 21 CFR 888.3030
Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories
Regulatory Class: II Product Code: HRS Dated: March 9, 2005 Received: March 14, 2005
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bected. Be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard) the enactment date of the Medical Device Amendments, or to conniner or prior to may 20, 2017).
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug de vices that have been require approval of a premarket approval application (PMA). and Costietle 710 (110.) that to novice, subject to the general controls provisions of the Act. The r ou may, dicierore, 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 it may of Subject to Saon addinensa Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of reacting your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not nean 1 Trase of advised that I Dr of issuates as our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I cacraf statutes and regarations and admited to: registration and listing (21 Comply with an the Act 8 requirements, not 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Kathy Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whil anow you to oegin maticoing your and of your device of your device to a legally prematics notification. "The PDT Imazing cification 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 If you desire specific davice for your as 1240) 276-0120 . Also, please note the regulation entitled, Contact the Office of Compunance at (21 the Part 807.97). You may obtain Misoranding by relevelec to promance no ilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
VI Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates Device Name:
Indications/Contraindications:
The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Stylo Murdu
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number __
§ 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.