(14 days)
K/DEN number: Not Found
Not Found
No
The device description is purely mechanical and describes a surgical implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an orthopedic implant for stabilizing bone fractures, which is a structural support rather than a device that delivers therapy.
No
The device is described as an implant used to treat bone fractures, specifically for stabilization and fixation of the femoral shaft. Its purpose is therapeutic, not diagnostic.
No
The device description clearly describes a physical implantable medical device (plate, screws, etc.) used for fracture fixation, not a software-only device.
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 provided description clearly describes a surgical implant (a plate and screws) used to stabilize bone fractures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to treat bone fractures, which is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the Synthes Universal Locking Trochanter Stabilization Plate for DHS® or LCP® DHHS is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Universal Locking Trochanter Stabilization Plate for DHS® or LCP® DHHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS®) or the LCP® Dynamic Helical Hip System (DHHS) side plates with four or more holes.
Product codes
HRS
Device Description
The Synthes ULTSP for DHS® and LCP DHHS fits over the sideplate of the Synthes DHS and LCP® DHHS. The ULTSP screw holes line up with the most proximal screw holes of the DHS and LCP DHHS sideplate and accept 4.5 mm cortex screws used for femoral shaft fixation. Slots accommodate both the DHS lag screw or the LCP DHHS Helix Blade and a parallel anti-rotational screw. The screw slot for the anti-rotational screw accepts a 6.5 mm cancellous bone screw or 6.5 mm, 7.0 mm or 7.3 mm cannulated screw. The proximal extension of the plate resides along the lateral side of the greater trochanter. The proximal locking holes of the ULTSP accept 3.5 mm locking screws and/or k-wires, cables, or sutures up to 2.0 mm in diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft, greater trochanter
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 Trochanter Stabilization Plate (TSP) for DHS
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
OCT 1 2 2005
Page 1 __ of __ 1 3.0 510(k) Summary Synthes (USA) Sponsor: 1302 Wrights Lane East West Chester, PA 19380 (610) 719-5000 Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) Device Name: Class II, §888.3030 - Single/multiple component metallic bone Classification: fixation appliances and accessories Synthes Trochanter Stabilization Plate (TSP) for DHS Predicate Devices: The Synthes ULTSP for DHS® and LCP DHHS fits over the Device Description: sideplate of the Synthes DHS and LCP® DHHS. The ULTSP screw holes line up with the most proximal screw holes of the DHS and LCP DHHS sideplate and accept 4.5 mm cortex screws used for femoral shaft fixation. Slots accommodate both the DHS lag screw or the LCP DHHS Helix Blade and a parallel anti-rotational screw. The screw slot for the anti-rotational screw accepts a 6.5 mm cancellous bone screw or 6.5 mm, 7.0 mm or 7.3 mm cannulated screw. The proximal extension of the plate resides along the lateral side of the greater trochanter. The proximal locking holes of the ULTSP accept 3.5 mm locking screws and/or k-wires, cables, or sutures up to 2.0 mm in diameter. The Synthes Universal Locking Trochanter Stabilization Plate for Intended Use: DHS® or LCP DHHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS®) or the LCP Dynamic Helical Hip System (DHHS) side plates with four or more holes. Substantial Information presented supports substantial equivalence. Equivalence:
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines, symbolizing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 2 2005
Sheri L. Musgnung Sr. Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K052677 Trade/Device Name: Synthes (USA) Universal Locking Trochanter Stabilization Plate (ULTSP) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: September 27, 2005 Received: September 29, 2005
Dear Ms. Musgnung:
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 encreative) it cegandy to together that of the Medical Device Amendments, or to conninered price to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de riccs that have been rocksonical require approval of a premarket approval application (PMA). alla Costiete Act (71ct) that do not required to the general controls provisions of the Act. The r ou may, dicierore, mance the Act include requirements for annual registration, listing of general controls provisions of use ice, 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 above) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outs neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dri of issuaires over device complies with other requirements of the Act that I DA has made a develminations administered by other Federal agencies. You must or any I cuchar statutes and regulations and and limited to: registration and listing (21 comply with an the Act 31equirements) (1) ; good manufacturing practice requirements as set CI K I at 607), adomig (21 OF R Part 820), and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'ls cognifinding of substantial equivalence of your device to a legally premailed notifications on "certain" 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 a sent office of Compliance at (240) 276-0120. 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 Manufacturers, 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/industry/support/index.html
Sincerely yours,
2
Sor Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
KOSZ677
510(k) Number (if known):
Device Name:
2.0
Synthes (USA) Universal Locking Trochanter Stabilization Plate (ULTSP)
INDICATIONS FOR USE:
The Synthes Universal Locking Trochanter Stabilization Plate for DHS® or LCP® DHHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS®) or the LCP® Dynamic Helical Hip System (DHHS) sideplates with four or more holes.
Prescription Use X (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_