(56 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended to fix fractures and non-unions/malunions of the tibia, which are therapeutic interventions.
No
The device is a medical implant (plate) used for fixation of fractures and nonunions of the tibia, not for diagnosing conditions.
No
The device description clearly describes physical plates made of material, intended for surgical implantation, which are hardware components.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical implant (a plate) used to fix fractures and other bone issues in the tibia. It is physically implanted into the body and does not perform any tests on bodily samples.
Therefore, based on the provided information, the Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are a surgical implant, not an IVD.
N/A
Intended Use / Indications for 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. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.
Product codes (comma separated list FDA assigned to the subject device)
HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medial proximal tibia, medial tibia plateau, tibia shaft
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.
Synthes (USA) Large Fragment LCP T- Plate
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
SEP 1 7 2003
032269
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 (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) Large Fragment LCP T- Plate |
| 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. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft. |
| SUBSTANTIAL EQUIVALENCE | Comparative information presented supports substantial equivalence. |
| MATERIAL: | Titanium and Stainless Steel |
Confidential
1
Image /page/1/Picture/1 description: The image shows a black and white logo. The logo consists of three stylized birds in flight, arranged in a row and angled upwards to the right. The birds are enclosed within a circle. The text "PUBLIC HEALTH SERVICE" is written around the top half of the circle.
Public Health Service
SEP 1 7 2003
Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850
Ms Lisa M Boyle Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K032269
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: July 22, 2003 Received: July 23, 2003
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Ms. Lisa M. Boyle
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). You may obtain other general information on your responsibilities under the Act 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 vours.
Sincerely yours,
Mark N. Millikan
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
Page _________________________________________________________________________________________________________________________________________________________________________
030669 510(k) Number (if known):
Device Name: Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates
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. Also, for use in the fixation of qsteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft.
(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
Mark A Milkenos
General. Restorative and Neurological Device
510(k) .
Confidential