(119 days)
The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults.
Specific indications for the 100°, 120°, 130°, 140°, 150° plates include:
• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal metaphyseal fractures
• Diaphyseal fractures
• Pathologic fractures
• Prophylactic use for impending pathologic fractures
Specific indications for the 90° plates include:
• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal and distal metaphyseal fractures
• Diaphyseal fractures
• Pathologic fractures
• Prophylactic use for impending pathologic fractures
The system is a collection of plates used to treat fractures and osteotomies of the femur in infants, children, adolescents, and small statured adults. The complete system includes the following:
• 3.5mm and 5.0 mm plates with a 90° angle
• 2.7mm, 3.5mm and 5.0 mm plates with a 100° angle
• 2.7mm, 3.5mm and 5.0 mm plates with a 110° angle
• 3.5mm and 5.0 mm plates with a 120° angle
• 2.7mm, 3.5mm and 5.0 mm plates with a 130° angle
• 3.5mm and 5.0 mm plates with a 140° angle
• 3.5mm and 5.0 mm plates with a 150° angle
The system accepts existing cortical and locking screws, and features allows for both dynamic compression and locking through Combi holes. The plates are universally designed for both left and right use.
The provided text describes a medical device, the "Synthes Pediatric LCP Plates," and its regulatory clearance (510(k)). This document, however, does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML-driven device's performance.
The document is a 510(k) summary for a traditional medical device (bone fixation plates), which primarily focuses on demonstrating substantial equivalence to predicate devices through design characteristics, materials, and engineering strength analysis and fatigue testing.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device. These concepts are not applicable to the type of device and regulatory submission described in the input.
{0}------------------------------------------------
K//2085
Page 1/2
Attachment B: Updated 510(k) Summary
| Date Prepared: November 16, 2011 | |
|---|---|
| Sponsor: | SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6854 |
| Device Name: | Synthes Pediatric LCP Plates |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bonefixation appliances and accessories.Product Code: HRS |
| Predicate Device: | Synthes LCP Pediatric Plate System (K062872, K072095)Synthes Angled Blade Plates (Pre-amendment, K914546)Synthes 3.5mm Curved LCP Plates (K092609) |
| Device Description: | The system is a collection of plates used to treat fractures and osteotomies of thefemur in infants, children, adolescents, and small statured adults. The completesystem includes the following:• 3.5mm and 5.0 mm plates with a 90° angle• 2.7mm, 3.5mm and 5.0 mm plates with a 100° angle• 2.7mm, 3.5mm and 5.0 mm plates with a 110° angle• 3.5mm and 5.0 mm plates with a 120° angle• 2.7mm, 3.5mm and 5.0 mm plates with a 130° angle• 3.5mm and 5.0 mm plates with a 140° angle• 3.5mm and 5.0 mm plates with a 150° angleThe system accepts existing cortical and locking screws, and features allows forboth dynamic compression and locking through Combi holes. The plates areuniversally designed for both left and right use. |
| Intended Use: | The Synthes (USA) Pediatric LCP Plate System is indicated for fixation offractures (including pathologic and impending pathologic fractures) andosteotomies of the femur in infants, children, adolescents and small staturedadults.Specific indications for the 100°, 120°, 130°, 140°, 150° plates include:• Varus, valgus, rotational and/or shortening osteotomies• Femoral neck and/or pertrochanteric fractures• Proximal metaphyseal fractures• Diaphyseal fractures• Pathologic fractures• Prophylactic use for impending pathologic fractures |
| Specific indications for the 90° plates include: | |
| • Varus, valgus, rotational and/or shortening osteotomies | |
| • Femoral neck and/or pertrochanteric fractures | |
| • Proximal and distal metaphyseal fractures | |
| • Diaphyseal fractures | |
| • Pathologic fractures | |
| • Prophylactic use for impending pathologic fractures | |
| • | |
| SubstantialEquivalence: | Both the subject Synthes Pediatric LCP Plate System and predicate SynthesLCP Pediatric Plate System, Angled Blade Plates, and 3.5mm Curved LCPPlates have similar indications, design characteristics, materials, andperformance characteristics. Engineering strength analysis and fatigue testingwas completed for the plates included in the Synthes Pediatric LCP PlateSystem. |
{1}------------------------------------------------
112085
Page 2/2
l
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2013
Synthes % Ms. Angela F. Lassandro Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K112085
Trade/Device Name: Synthes LCP Pediatric Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 14, 2011 Received: October 18, 2011
Dear Ms. Lassandro:
This letter corrects our substantially equivalent letter of November 17, 2011.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{3}------------------------------------------------
Page 2 - Ms. Angela F. Lassandro
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The name is written in black ink. The letters "D", "K", and "A" are stylized with a pattern of lines and shapes.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Revised Indications for Use Statement
510(k) Number (if known): K112085
Synthes Pediatric LCP Plates Device Name:
Indications for Use:
The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults.
Specific indications for the 100°, 110°, 120°, 130°, 140°, 150° plates include:
- · Varus, valgus, rotational and/or shortening osteotomies
- · Femoral neck and/or pertrochanteric fractures
- · Proximal metaphyseal fractures
- · Diaphyseal fractures
- · Pathologic fractures
- · Prophylactic use for impending pathologic fractures
Specific indications for the 90° plates include:
- · Varus, valgus, rotational and/or shortening osteotomies
- · Femoral neck and/or pertrochanteric fractures
- Proximal and distal metaphyseal fractures
- · Diaphyseal fractures
- · Pathologic fractures
- · Prophylactic use for impending pathologic fractures
AND/OR
x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use _ (Per 21 CFR 801.109)
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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
§ 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.