(55 days)
Not Applicable
Not Found
No
The summary describes a mechanical orthopedic plate and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device, Synthes Curved Broad Plates and Curved Condylar Plates, are intended for fixation of bones and fractures, which are structural and mechanical functions. They do not directly treat or prevent a disease, nor restore, modify, or correct a body function in a therapeutic sense.
No
Explanation: The device is described as plates intended for fixation of various long bones and fractures, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly indicates that the device is a physical plate (Synthes LCP® Curved Plates) intended for bone fixation, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- The Synthes Curved Broad Plates and Curved Condylar Plates are surgical implants used to fix bones in vivo (inside the body). Their purpose is mechanical support and stabilization of fractures.
The provided information clearly describes a surgical implant for bone fixation, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions.
The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including : supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.
Product codes
KTT
Device Description
The Synthes LCP® Curved Plates have a slight curve to better match the anatomy of the bone. The plates have a limited contact profile design and includes combination dynamic compression/locking screw holes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various long bones, such as the humerus, femur, and tibia, distal femur
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)
Synthes Large Fragment Dynamic Compression System, Synthes Locking Condylar Plating System
Reference Device(s)
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 logo for SYNTHES, a medical device company. The logo consists of a stylized symbol followed by the word "SYNTHES" in bold, sans-serif font with a registered trademark symbol. There is a long underline beneath the logo and some handwritten text to the right of the logo.
Koy911
- SEP 8 2004
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1690 Russell Road | ||
| Paoli, PA 19301 | ||
| (610) 647-9700 | ||
| Device Name: | Synthes LCP® Curved Plates | |
| Classification: | 21 CFR 888.3030: Single/Multiple component metallic bone | |
| fixation appliances and accessories | ||
| Predicate Devices: | Synthes Large Fragment Dynamic Compression System | |
| Synthes Locking Condylar Plating System | ||
| Device Description: | The Synthes LCP® Curved Plates have a slight curve to better | |
| match the anatomy of the bone. The plates have a limited contact | ||
| profile design and includes combination dynamic | ||
| compression/locking screw holes. | ||
| Intended Use: | The Synthes Curved Broad Plates are intended for fixation of | |
| various long bones, such as the humerus, femur, and tibia. They | ||
| are also for use in fixation of peri-prosthetic fractures, osteopenic | ||
| bone and non-unions or malunions. |
The Synthes Curved Condylar Plates are intended for buttressing
multifragmentary distal femur fractures, including : supracondylar,
intra-articular and extra-articular condylar fractures, peri-prosthetic
fractures and fractures in normal or osteopenic bone,
nonunions/malunions, and osteotomies of the femur. |
| | Substantial Equivalence: | Comparative information presented supports substantial
equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pensylvania 19301
Re: K041911
Device Name: Synthes (USA) LCP® Curved Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 13, 2004 Received: July 15, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave actions. And and marketed predicate devices marketed in interstate for use stated in the encreate) to 10g. 35 the enactment date of the Medical Device Amendments, or to comments prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (1101) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, maniel and not include requirements for annual registration, listing of gencial controls provisions of the tice, 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 (500 worro). Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to subli additions, 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 Frease be advised that I Dri 3 ibsualles or our device complies with other requirements of the Act that I DA has made a decemmandations administered by other Federal agencies. You must or any I catal statutes and registments, 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 in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quant) by ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogen maing of substantial equivalence of your device to a legally prematication: The PDF Pinnersgassification 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 spocitio acrievier J at (301) 594-4659. Also, please note the regulation entitled, Connact the Office of Compuner as (et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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 yours,
Sincerely, yours,
Mark M. Milkerso
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
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 runs beneath the word "SYNTHES" and the logo. A small registration mark is located to the right of the word.
of l Page 1
Indications for Use
510(k) Number (if known):
K04L911
Device Name:
2.0
Synthes (USA) LCP® Curved Plates
Indications for Use:
The Synthes Curved Broad Plates are intended for fixation of various long bones, such as the I he Syllines Curved Droad I was a lass for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions.
The Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur I he Synthes Curved Condylar Intra-articular and extra-articular condylar fractures, peri-Tractures, niciduling : Supracondytary miral or osteopenic bone, nonunions/malunions/malunions, and osteotomies of the femur.
R. Mark A. Wilkerson
Division Sign-Off
Division of General, Restorative, and Neurological Levices
K041911
510(k) Number
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)