(138 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any AI/ML components or functions.
No.
This device is a surgical implant (plates and screws) used for fixation of bones, not for therapy or treatment of diseases.
No
The device is a system of plates and screws used for fixation in reconstructive foot surgery, not for diagnosing conditions. Its intended use is for treatment (fixation of osteotomies, fusions, fractures, etc.), not diagnosis.
No
The device description clearly states it consists of physical components like plates and screws made of stainless steel and titanium alloy, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing bones in the foot and ankle. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details plates and screws made of implant-grade materials, which are used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment.
N/A
Intended Use / Indications for Use
The Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Synthes 2.4/2.7 mm Variable Angle LCP Forefoot / Midfoot System consists of anatomic and procedure specific plates, including 1st MTP Fusion, TMT Fusion, Opening Wedge Osteotomy, X and Straight Fusion, Navicular, Cuboid, and Mesh Plates, with variable angle locking screws and cortex screws to aid in reconstructive foot surgery. The system components are offered in versions composed of implant grade stainless steel and titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle
Indicated Patient Age Range
adult and adolescent (12 - 21 years) patients
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 2.4 mm / 2.7 mm Locking Foot Module (K071264), Synthes Modular Mini Fragment LCP System (K063049), DARCO Locking Bone Plate System (K061808), Merete Locking Bone Plate System (K090063), OrthoHelix Surgical Designs, Inc. MaxLock Extreme™ Extremity Plating System with Variable Angle Technology (K100618), OrthoHelix Surgical Designs, Inc. Modular Foot System (K073624), Smith & Nephew VLP Foot Plating System (K090675)
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.
0
@ SYNTHES® KIJ0046
| 3.0 | 510(k) Summary | Page 1 of 1 | |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| Karl J. Nittinger | |||
| 1301 Goshen Parkway | |||
| West Chester, PA 19380 | |||
| (610) 719-6941 | |||
| FAX (484) 356-9682 | AUG 03 2010 | ||
| Date Prepared: | May 25, 2010 | ||
| Device Name: | Synthes 2.4 mm / 2.7 mm Variable Angle (VA)-LCP Forefoot / Midfoot | ||
| System | |||
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone fixation | ||
| appliance and accessories. | |||
| Predicate Device: | Synthes 2.4 mm / 2.7 mm Locking Foot Module (K071264) | ||
| Synthes Modular Mini Fragment LCP System (K063049) | |||
| DARCO Locking Bone Plate System (K061808) | |||
| Merete Locking Bone Plate System (K090063) | |||
| OrthoHelix Surgical Designs, Inc. MaxLock Extreme™ Extremity Plating | |||
| System with Variable Angle Technology (K100618) | |||
| OrthoHelix Surgical Designs, Inc. Modular Foot System (K073624) | |||
| Smith & Nephew VLP Foot Plating System (K090675) | |||
| Device Description: | The Synthes 2.4/2.7 mm Variable Angle LCP Forefoot / Midfoot System | ||
| consists of anatomic and procedure specific plates, including 1st MTP | |||
| Fusion, TMT Fusion, Opening Wedge Osteotomy, X and Straight Fusion, | |||
| Navicular, Cuboid, and Mesh Plates, with variable angle locking screws | |||
| and cortex screws to aid in reconstructive foot surgery. The system | |||
| components are offered in versions composed of implant grade stainless | |||
| steel and titanium alloy. | |||
| Indications: | The Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot / Midfoot System is | ||
| indicated for fixation of osteotomies, fusions, fractures, nonunions, | |||
| malunions and replantations of small bones and small bone fragments in | |||
| adult and adolescent (12 - 21 years) patients, including the foot and ankle, | |||
| and particularly in osteopenic bone. | |||
| Substantial | |||
| Equivalence: | Information presented supports substantial equivalence of the Synthes | ||
| 2.4mm / 2.7mm VA-LCP Forefoot / Midfoot Plates to the predicate devices. The proposed plates have the same indications for use, are similar | |||
| in design, incorporate the same fundamental product technology and are | |||
| composed of the same materials. Additionally, calculations comparing the | |||
| bending strength of the subject and predicate devices based on geometric | |||
| analyses and the material characteristics defined in standards: ASTM | |||
| F138-03 and ASTM F1295-05 were performed and the results support | |||
| substantial equivalence. |
1
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Synthes (USA) % Mr. Karl J. Nittinger Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
AUG 08 2010
Re: K100776
Trade/Device Name: Synthes 2.4mm/2.7 mm Variable Angle LCP forefoot/ Midfoot system 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: July 9, 2010 Received: July 13, 2010
Dear Mr. Nittinger:
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.
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
2
Page 2 - Mr. Karl J. Nittinger
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Mark N. Millerson
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
AUG 0 3 2010
K100776 510(k) Number (if known):
Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System Device Name:
Indications for Use:
The Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System is indicated for fixation of osteotomies, fusions, fractures, nonunions, malunions and replantations of small bones and small bone fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
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)
lefl
7 *
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Divisionative Devices
510(k) Number K100776