(62 days)
Not Found
No
The device description and intended use describe a mechanical plate and screw system for fracture fixation, with no mention of software, algorithms, or any AI/ML related terms.
Yes.
The device is described as a plate and screw system intended to treat specific types of hip fractures, which is a therapeutic purpose.
No
The device is a system of plates and screws used to treat fractures, not to diagnose them. Its intended use is for treatment, not diagnostic purposes.
No
The device description clearly states it is a "plate and screw system," which are physical hardware components used in orthopedic surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures." This describes a surgical implant used to fix bone fractures, which is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a "plate and screw system" designed for surgical implantation. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Synthes LCP ® Dynamic Helical Hip System is a surgical implant for treating bone fractures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
Product codes
KTT
Device Description
Synthes LCP ® Dynamic Helical Hip System is a plate and screw system that consists of a straight plate with an angled barrel that accepts a helical blade. The plates have a grooved undersurface, contain combination locking and dynamic compression holes and are available in various barrel angles and plate lengths. The sideplate combination holes accept 5.0 mm locking screws and 4.5 mm cortex screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Dynamic Helical Hip System
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
. JAN 1 3 2004
page 10f1
K033556
- 3.0 510(k) Summary:
| Sponsor | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bonnie Smith |
| Device Name | Synthes (USA) LCP ® Dynamic Helical Hip System™ |
| Device Classification | 21 CFR: 888.3030 - Single/multiple component metallic bone
fixation appliance and accessories. |
| Predicate Device | Synthes Dynamic Helical Hip System |
| Description of Device | Synthes LCP ® Dynamic Helical Hip System is a plate and screw
system that consists of a straight plate with an angled barrel that
accepts a helical blade. The plates have a grooved undersurface,
contain combination locking and dynamic compression holes and are
available in various barrel angles and plate lengths. The sideplate
combination holes accept 5.0 mm locking screws and 4.5 mm cortex
screws. |
| Indications | Intended to treat stable and unstable intertrochanteric,
subtrochanteric and basilar neck fractures in which a stable medial
buttress can be reconstructed. |
| Material | Stainless Steel |
| Substantial Equivalence | Documentation is provided which demonstrates that the Synthes
LCP ® Dynamic Helical Hip System is substantially equivalent to
other legally marketed Synthes devices. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle.
JAN 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Bonnie J. Smith Scnior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Rc: K033556
K035356
Trade/Device Name: Synthes (USA) LCP® Dynamic Helical Hip System™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 7, 2003 Received: November 12, 2003
Dear Ms. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 encreativent of the enactment date of the Medical Device Amendments, or to commerce processified 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). and consinete for (110) read the device, subject to the general controls provisions of the Act. The I va may, aterere, mains of the Act include requirements for annual registration, listing 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to Salen 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 i least be advised that i Dr Provision that your device complies with other requirements of the Act that I Dr And Internations administered by other Federal agencies. You must or any I edetar states and equirements, 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 (21 CFR Part 820); and if applicable, the electronic forth in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Bonnie J. Smith
This letter will allow you to begin marketing your device as described in your Scction 510(k) I mis letter will and w you to organization of substantial equivalence of your device to a legally prematice hotification. The 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 If you desire speeme 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 other general 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 yours.
Marke McMullerson
Celia 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. Indications for Use
Page 1 of l
510(k) Number (if known):
Device Name:
Synthes (USA) LCP® Dynamic Helical Hip System™
Indications for Use:
To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
for Mark N Melken
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
6033556
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use