(36 days)
Synthes Reconstruction Plates
Not Found
No
The summary describes a mechanical implant (plates) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being intended for "pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula," which are therapeutic interventions.
No
Explanation: The device is described as reconstruction plates intended for fixation of fractures, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical plates made of material, which are hardware components.
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 Synthes Low Profile Reconstruction Plates are described as implants used for the surgical fixation of bone fractures. They are physical devices implanted into the body.
- Intended Use: The intended use is for "pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the Synthes Low Profile Reconstruction Plates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Synthes 3.5 mm Low Profile Reconstruction Plates consist of straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic, acetabular, distal humerus, clavicle, scapula.
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 Reconstruction Plates
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
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 cross-like figure inside. A registered trademark symbol is located to the right of the word.
(042397)
510(k) Summary 3.0
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- Synthes (USA) Sponsor: 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Synthes Low Profile Reconstruction Plates Device Name: 21 CFR 888.3030: Single/Multiple component metallic bone Classification: fixation appliances and accessories Synthes Reconstruction Plates Predicate Devices: The Synthes 3.5 mm Low Profile Reconstruction Plates consist of Device Description: straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending. The Synthes Low Profile Reconstruction Plates are intended for Intended Use: pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula. Comparative information presented supports substantial Substantial equivalence. Equivalence:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
QCT 7 - 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042377
K042377
Trade/Device Name: Synthes (USA) Low Profile Reconstruction 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: August 31, 2004 Received: September 1, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bected by the 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 encrosure) to regars and ment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in eacordance with the provisions of the Federal Food, Drug, devices mat have been recuire in asse approval of a premarket approval application (PMA). alle Cosmette Act (1101) that to hevice, subject to the general controls provisions of the Act. The I ou may, morelore, mainer of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (800 a00 roy ols. Existing major regulations affecting your device can may be subject to back acceral Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oe devised that i Drimination that your device complies with other requirements of the Act that I DT has made a actor regulations administered by other Federal agencies. You must or any I odotal bather and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 6077, laceming (21 CFR Part 820); and if applicable, the electronic form in the quarty byections (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) This letter will allow you to begin makemig your article as wasnese of your device to a legally premarket notification. The PDA midning of backannal sparents 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 on the considere If you desire specific advice for your do rice can and on a comments of a common and conlact the Office of Comphalled at (210) = i S = = = = = 807.97). You may obtain " Misbranding by reletence to premarket notified on der the Act from the Division of Small other general information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the news are two (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Mckennon
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
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Image /page/3/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A horizontal line is present below the word, adding a sense of completion to the overall design. The logo and text are clear and legible, suggesting a professional and established brand.
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Indications for Usc
510(k) Number (if known):
Device Name:
2.0
Synthes (USA) Low Profile Reconstruction Plates
Indications for Use:
The Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular
and secures and construction in the collection of consula i he Symnes Low Prome Reconstruction Practures of the distal humerus, clavicle, and scapula.
X Prescription Use_ (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K04 2377