(138 days)
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.
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.
The information provided describes a medical device, the Synthes 2.4 mm / 2.7 mm Variable Angle (VA)-LCP Forefoot / Midfoot System, and its 510(k) summary for clearance by the FDA. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and performance data as one would typically find for a new, non-substantially equivalent device.
Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, etc.) are not applicable in this context. The clearance is based on the device's design similarity, material composition, and mechanical properties compared to already approved devices.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate devices. | The proposed plates have the same indications for use as the predicate devices: 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, particularly in osteopenic bone. |
| Design: Similar to predicate devices. | The proposed plates are similar in design to the predicate devices. This includes anatomic and procedure specific plates (e.g., 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. |
| Fundamental Product Technology: Same as predicate devices. | The proposed plates incorporate the same fundamental product technology as the predicate devices (implied to be rigid fixation for small bone fragments). |
| Materials: Composed of the same materials as predicate devices. | The system components are offered in versions composed of implant grade stainless steel and titanium alloy, which are the same materials used in the predicate devices (as implied by comparison to ASTM F138-03 and ASTM F1295-05 standards for these materials). |
| Bending Strength: Supports substantial equivalence to predicate devices based on geometric and material analyses. | 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. The results support substantial equivalence. (Specific numerical performance values for bending strength are not provided, only that they support equivalence to predicate devices conforming to these standards). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) submission describes a device for which substantial equivalence is primarily established through comparisons of design, materials, indications, and mechanical testing (bending strength calculations) against legally marketed predicate devices. It does not involve a clinical study with a "test set" of patients or data in the traditional sense. The evaluation is based on engineering principles and regulatory precedent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point 2. No ground truth based on expert review of clinical cases was established for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a bone fixation system (plates and screws), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices, supported by their various regulatory clearances and adherence to recognized material and performance standards (e.g., ASTM F138-03 and ASTM F1295-05 for materials, and implied mechanical performance consistent with the predicate devices' intended use). The new device demonstrates "substantial equivalence" to this existing "ground truth."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device requiring a training set.
{0}------------------------------------------------
@ SYNTHES® KIJ0046
| 3.0 | 510(k) Summary | Page 1 of 1 | |
|---|---|---|---|
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941FAX (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 / MidfootSystem | ||
| Classification: | Class II, §888.3030 - Single / multiple component metallic bone fixationappliance 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 PlatingSystem 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 Systemconsists of anatomic and procedure specific plates, including 1st MTPFusion, TMT Fusion, Opening Wedge Osteotomy, X and Straight Fusion,Navicular, Cuboid, and Mesh Plates, with variable angle locking screwsand cortex screws to aid in reconstructive foot surgery. The systemcomponents are offered in versions composed of implant grade stainlesssteel and titanium alloy. | ||
| Indications: | The Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot / Midfoot System isindicated for fixation of osteotomies, fusions, fractures, nonunions,malunions and replantations of small bones and small bone fragments inadult and adolescent (12 - 21 years) patients, including the foot and ankle,and particularly in osteopenic bone. | ||
| SubstantialEquivalence: | Information presented supports substantial equivalence of the Synthes2.4mm / 2.7mm VA-LCP Forefoot / Midfoot Plates to the predicate devices. The proposed plates have the same indications for use, are similarin design, incorporate the same fundamental product technology and arecomposed of the same materials. Additionally, calculations comparing thebending strength of the subject and predicate devices based on geometricanalyses and the material characteristics defined in standards: ASTMF138-03 and ASTM F1295-05 were performed and the results supportsubstantial 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
§ 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.