(84 days)
N/A
Not Found
No
The 510(k) summary describes a mechanical implant system (plates and screws) for bone fractures. There is no mention of software, algorithms, image processing, AI, or ML.
Yes
The device is a system of plates and screws used to fix fractures of the proximal radius, which is a therapeutic intervention.
No
The device is a surgical implant (plate system) used for treating fractures, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical plates and screws made of metal, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for treating fractures of the proximal radius. This is a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The description details a system of plates and screws designed for surgical fixation of bones. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
Therefore, based on the provided information, the Synthes LCP Radial Head Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes LCP Radial Head Plating System is indicated for extra-articular and intra-articular fractures of the proximal radius and for multi-fragmented radial neck fractures.
Product codes
HRS
Device Description
The Synthes LCP Radial Head Plate System consists of radial head rim and neck plates. The plates are pre-contoured to match the anatomy of the proximal radius with a limited contact low profile design. The plates feature locking combination holes and round locking holes which accept 2.0 and 2.4 & 2.7 mm cortex screws, and 2.4 mm locking screws. The System will be available in Stainless Steel, CP Titanium and Titanium Alloy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal radius, radial neck
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 LCP Distal Radius Volar Plate
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
'JUN 1 8 2004
Summary of Safety and Effectiveness Information [510(k) Summary] 3.0
040777
page 1 of 1
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | LCP Radial Head Plating System |
| CLASSIFICATION: | Class II, 21 CFR 888.3030: Single / Multiple component bone fixation
appliances and accessories. |
| PREDICATE DEVICE: | Synthes LCP Distal Radius Volar Plate |
| DEVICE DESCRIPTION: | The Synthes LCP Radial Head Plate System consists of radial head rim and
neck plates. The plates are pre-contoured to match the anatomy of the
proximal radius with a limited contact low profile design. The plates
feature locking combination holes and round locking holes which accept
2.0 and 2.4 & 2.7 mm cortex screws, and 2.4 mm locking screws. The
System will be available in Stainless Steel, CP Titanium and Titanium
Alloy |
| INTENDED USE: | The Synthes LCP Radial Head Plating System is indicated for extra-
articular and intra-articular fractures of the proximal radius and for multi-
fragmented radial neck fractures. |
| SUBSTANTIAL
EQUIVALENCE: | Docmentation is provided which demonstrates that the Synthes LCP Radial
Head Plating System is substantially equivalent to other legally marketed
devices. |
Confidential
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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2004
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania
Re: K040777
Trade/Device Name: Synthes (USA) LCP Radial Head Plating System 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 25, 2004 Received: March 26, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 3 rQxy presidentially equivalent (for the indications ferenced above and nave acteringsally marketed predicate devices marketed in interstate for tise stated in the encrosuly to regars the Medical Device Amendments, or to commerce provision to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alla Cosmette Act (110.) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the det res, buyer to the more of the manual registration, listing of general controls provisions of uactice, 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 (see abort) ins. Existing major regulations affecting your device can may be subject to such additional controller Extoning and to 898. In addition, FDA may be found in the Outs oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a succession of the requirements of the Act that IDA has made a determination administered by other Federal agencies. You must of ally reactal statutes and regulations adminities bot not limited to: registration and listing (21 comply with an the 7te 31equirements,01); good manufacturing practice requirements as set CTN in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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) I his letter will anow you to begin manentig your antial equivalence of your device to a legally premarket nothication. The PDA miding of backanda experiend 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 advice for your act (301) 594-4659. Also, please note the regulation entitled, contact the Office of Complance at (501) 37 cart 807.97). You may obtain "Misbranding by reference to premanter nouthead in the Act from the Division of Small other general information on your responsion and at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at in the largement html (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A Millerman
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
Indications for Use
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K040777 |
| Device Name: | Synthes (USA) LCP Radial Head Plating System |
Indications for use:
The Synthes LCP Radial Head Plate System is indicated for extra-articular and intra-articular fractures of The Synthes LCT Radial Hoad Firagmented radial neck fractures.
R. Mark A. Milkerson
ision Sign-O Division of General, Restorative, and Neurological Devices
510(k) Number K040777
Prescription Use
(Per 21 CFR 801.109) X
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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