(65 days)
(USA) LCP Proximal Femur Plates
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant (a bone plate) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as "LCP Proximal Femur Hook Plate" and is intended for treating various fractures and osteotomies of the femur, which are medical conditions, making it a therapeutic device.
No
The device is a bone plate intended for the treatment of fractures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical implantable plate and associated screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Synthes LCP Proximal Femur Hook Plate is a surgical implant used to fix fractures in the femur. 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 fractures of the femur, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LCP Proximal Femur Hook Plates are intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
Product codes
HRS
Device Description
The LCP Proximal Femur Hook Plates are contoured to match the anatomy of the proximal femur with a limited contact low profile design. The plate has dynamic compression holes combined with conical shaped threaded screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or 5.0 mm locking screws, 5.0mm cannulated screws, and 7.3 mm cannulated locking & cannulated conical screws. The plates are available in a various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, proximal end of the 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 (USA) LCP Proximal Femur Plates
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
SEP - 4 2003
K032032
page 1 of 1
3.0 Summary of Safety and Effectiveness Information [510(k) Summary]
| SPONSOR: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700
Contact: Lisa M. Boyle |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) LCP Proximal Femur Hook Plates |
| CLASSIFICATION: | Class II § 21 CFR 888.3030: Plate , Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) LCP Proximal Femur Plates |
| DEVICE DESCRIPTION: | The LCP Proximal Femur Hook Plates are contoured to match the anatomy
of the proximal femur with a limited contact low profile design. The plate
has dynamic compression holes combined with conical shaped threaded
screw holes, which accept 4.5 mm cortex, 4.5 mm shaft screws, 4.0 mm or
5.0 mm locking screws, 5.0mm cannulated screws, and 7.3 mm cannulated
locking & cannulated conical screws. The plates are available in a various
lengths. |
| INTENDED USE: | The LCP Proximal Femur Hook Plates are intended for fractures of the
femur including: fractures of the trochanteric region, trochanteric simple,
cervicotrochanteric, trochanterodiaphyseal, multifragmentary
pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse
or with additional fracture of medial cortex. Fractures of the proximal end
of the femur combined with ispsilateral shaft fractures, metastatic fracture
of the proximal femur and osteotomies of the proximal femur. |
| SUBSTANTIAL
EQUIVALENCE: | Comparative information presented supports substantial equivalence.
The term "substantial equivalence" as used in this 510(k) notification is
limited to the definition of substantial equivalence found in the Federal
Food, Drug and Cosmetic Act, as amended and as applied under 21CFR
807, Subpart E under which a device can be marketed without pre-market
approval or reclassification. A determination of substantial equivalency
under this notification is not intended to have any bearing whatsoever on
the resolution of patent infringement suits or any other patent matters. No
statements related to, or in support of substantial equivalence herein shall
be construed as an admission against interest under the US Patent Laws or
their application by the courts. |
Confidential
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 4 2003
Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301
Re: K032032
Trade/Device Name: Synthes (USA) LCP Proximal Femur Hook Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 30, 2003 Received: July 2, 2003
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 contact the Office of Compliance 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 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/dsma/dsmamain.html
Sincerely vours.
Mark N. Millman
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
2.0 Indications for Use Statement
Page 1 of 1
| 510(k) Number (if known): | K032032 |
|---|---|
| Device Name: | Synthes (USA) LCP Proximal Femur Hook Plates |
Indications: Synthes (USA) LCP Proximal Femur Hook Plate is intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General. Restorative
and Neurological Devices
| 510(k) Number | K032032 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
Confidential
.