(58 days)
Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as a system for fixation of fractures and osteotomies, which implies a supportive or corrective function rather than directly providing therapy.
No
Explanation: The device is an implantable surgical system (plate and screws) used for fixation of fractures and osteotomies of the proximal femur, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components (plates, screws) made of stainless steel, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a hip plate system) used for fixing fractures and osteotomies of the proximal femur. This is a device that is surgically implanted inside the body to provide structural support.
The function of this device is entirely mechanical and related to bone fixation, not to the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.
Specific indications include:
- intertrochanteric rotational and/or varus osteotomies
- femoral neck and/or pertrochanteric fractures
- intertrochanteric valgus osteotomies and/or rotational osteotomies
Product codes (comma separated list FDA assigned to the subject device)
JDS
Device Description
The Synthes (USA) Pediatric LCP Hip Plate System is available in 3.5 and 5.0 mm versions which include 100, 110, 120, and 150 degree angles. The plates are designed with three conical locking screw holes located at the head in conjunction with 3 or 4 combination locked-compression screw holes at the shaft. The fixed angle construct is created by means of three standard locking screws inserted through the head of the plate. The shaft of the plate accepts locking or cortex screws, depending on the nature of the fracture or the quality of bone.
The Synthes (USA) Pediatric LCP Hip Plate System Modifications to include 3.5 mm Cortex screws to be utilized with the plates.
The screws are manufactured from 316L stainless steel and available both sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
Indicated Patient Age Range
children, adolescents, and small statured adults
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes Pediatric LCP Hip Plate System, Synthes Angled Blade Plates
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A horizontal line is present beneath the word, adding emphasis to the brand name. The "®" symbol is located to the right of the word.
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA) | |
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| (610) 719-5000 | ||
| SEP 27 2007 | ||
| Contact: | Jill R. Sherman | |
| Synthes (USA) | ||
| 1301 Goshen Parkway | ||
| West Chester, PA 19380 | ||
| 610-719-6538 | ||
| Device Name: | Synthes (USA) Pediatric LCP Hip Plate System Modifications | |
| Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone | |
| fixation appliances and accessories. | ||
| Predicate Device: | Synthes Pediatric LCP Hip Plate System | |
| Synthes Angled Blade Plates | ||
| Device Description: | The Synthes (USA) Pediatric LCP Hip Plate System is available in | |
| 3.5 and 5.0 mm versions which include 100, 110, 120, and 150 | ||
| degree angles. The plates are designed with three conical locking | ||
| screw holes located at the head in conjunction with 3 or 4 | ||
| combination locked-compression screw holes at the shaft. The | ||
| fixed angle construct is created by means of three standard locking | ||
| screws inserted through the head of the plate. The shaft of the | ||
| plate accepts locking or cortex screws, depending on the nature of | ||
| the fracture or the quality of bone. | ||
| The Synthes (USA) Pediatric LCP Hip Plate System Modifications | ||
| to include 3.5 mm Cortex screws to be utilized with the plates. | ||
| The screws are manufactured from 316L stainless steel and | ||
| available both sterile and non-sterile. | ||
| Intended Use: | The Synthes (USA) Pediatric LCP Hip Plate System is intended for | |
| fixation of fractures and osteotomies of the proximal femur in | ||
| children, adolescents, and small statured adults. | ||
| Specific indications include: | ||
| • intertrochanteric rotational and/or varus osteotomies | ||
| • femoral neck and/or pertrochanteric fractures | ||
| • intertrochanteric valgus osteotomies and/or rotational | ||
| osteotomies | ||
| Substantial | ||
| Equivalence: | Information presented supports substantial equivalence. |
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2007
Synthes (USA) % Ms. Jill R. Sherman Regulatory Affairs / Compliance Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K072095
Trade/Device Name: Pediatric LCP Hip Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDS Dated: September 14, 2007 Received: September 17, 2007
Dear Ms. Sherman:
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 to 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
2
Page 2 - Ms. Jill R. Sherman
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. 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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark A. Mcllkeran
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. To the right of the word is a circled R, indicating that the word is a registered trademark. The word and logo are all on a white background.
| 2.0 | Revised Indications for Use |
|---|---|
| 510(k) Number (if known): | K072095 |
| Device Name: | Synthes (USA) Pediatric LCP Hip Plate System Modifications |
| Indications for Use: | The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults. |
Specific indications include: |
| | intertrochanteric rotational and/or varus osteotomiesfemoral neck and/or pertrochanteric fracturesintertrochanteric valgus osteotomies and/or rotational osteotomies |
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)
Mark A. Milkern
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
072095