(27 days)
Not Found
Not Found
No
The summary describes a mechanical plate and screw system for fracture fixation and contains no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as a "plate and screw system" intended "To treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures," which directly addresses and treats a medical condition.
No
The device description indicates it is a plate and screw system designed to treat fractures, not to diagnose them.
No
The device description clearly states it is a "plate and screw system" consisting of physical components like a plate, angled barrel, and helical blades. This indicates a hardware-based medical device, not a software-only one.
No, 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.
- Device Description: The description details a "plate and screw system" and "helical blades". These are physical components designed to be implanted in the body to stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health. This device does not involve the analysis of biological specimens.
This device is a surgical implant used for orthopedic fracture fixation.
N/A
Intended Use / Indications for Use
Synthes LCP® Dynamic Helical Hip System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
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. Synthes Helical blades, ranging in lengths from 135 mm to 150 mm are to be added to this system
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 LCP® 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.
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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 design inside. A horizontal line is present beneath the word, adding emphasis to the brand name.
Image /page/0/Picture/1 description: The image shows the text "K042895 Page 1 of 3". The text appears to be handwritten in black ink. There is a horizontal line below the text "Page 1 of 3".
NOV 1 6 2004
-
- 510(k) Summary:
| Sponsor: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sheri L. Musgnung |
| Device Name: | Synthes LCP® Dynamic Helical Hip System, Additional Helix
Blades |
| Device Classification: | 21 CFR 888.3030 -- "Single/multiple component metallic bone
fixation appliances and accessories" |
| Predicate Device: | Synthes LCP® 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. Synthes Helical blades, ranging in lengths from 135
mm to 150 mm are to be added to this system |
| Indications: | Synthes LCP® Dynamic Helical Hip System is 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, additional Helix Blades is substantially
equivalent to other legally marketed Synthes devices. |
.
000005
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2004
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301-0800
Re: K042895
K042895
Device Name: Synthes (USA) LCP® Dynamic Helical Hip System (LCP DHHS), Additional Helix Blades Regulation Number: 21 CFR 888.3030 Regulation Number. 21 CFK 886.5050
Regulation Name: Single, multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: October 29, 2004 Received: November 1, 2004
Dear Ms. Musgnung:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 910(x) premained in substantially equivalent (for the indications relerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosuly manactment date of the Medical Device Americal Forley of Food Drus commerce provi to May 20, 1776, the enaounce with the provisions of the Federal Food, Drug, devices that have been reclassince in accera was a proval approval application (PMA). and Cosment Act (Act) that do not require approvise to the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the Fiel libeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FRA may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Code of I saeral singerning your device in the Federal Register.
2
Page 2 – Ms. Sheri L. Musgnung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fillat IDA s Issualled of a succements with other requirements of the Act that FDA has made a decemination that Jour at 100 received agencies. You must or any rederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 801); good maker 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manus of substantial equivalence of your device to a legally premarket notification: "The PDA mailing of bation 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 specific as Compliance at (240) 276-0120. Also, please note the regulation entitled, Conder the Office of Company of Commarket notification" (21CFR Part 807.97). You may obtain Misoranumig by reference to premaintentibilities under the Act from the Division of Small other general informational on your respender 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 McMullan
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/0 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 underneath the word. The logo and word are likely part of a company or brand identity.
- Indications for Use
Page __ 1__ of________________________________________________________________________________________________________________________________________________________________
:
| 510(k) Number (if known): | K042895 |
|---|---|
| Device Name: | Synthes (USA) LCP® Dynamic Helical Hip System |
| (LCP DHHS), Additional Helix Blades | |
| Indications for Use: | To treat stable and unstable intertrochanteric, |
| subtrochanteric and basilar neck fractures in which a | |
| stable medial buttress can be reconstructed. |
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
f
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
000004
Number K04 2875