(90 days)
The Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 2.7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21years) when used with the Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).
The Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures. osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Screws have self-tapping features, stardrive, hexdrive, or cruciform head recesses, and are manufactured from stainless steel, commercially pure titanium, and/or titanium alloy. Cortex screws are offered both sterile and non sterile and are available in various lengths. Screws may be used independently or with any Synthes plate which accepts 1.0mm, 1.3mm, 2.0mm, 2.4mm, 2.7mm, 3.5mm, 4.0mm, and 4.5mm cortex screws. The subject screws, when used in pediatric applications, may be used independently or with compatible Synthes plates which are also indicated for pediatric populations.
The provided text describes Synthes Cortical Screws and their intended uses, focusing on expanding indications for pediatric populations. The study primarily relies on demonstrating substantial equivalence to predicate devices and does NOT involve an AI device. Therefore, many of the questions related to AI-specific studies, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail table format for the device as a whole. Instead, it details the basis for substantial equivalence to existing predicate devices.
| Acceptance Criterion (Basis for Substantial Equivalence to Predicate Devices) | Reported Device Performance/Comparison (Synthes Cortical Screws vs. Predicates) |
|---|---|
| Indications for Use (Adults) | Similar indications for use in trauma, reconstructive procedures, and general surgery of various bones. |
| Indications for Use (Pediatric Expansion) | Supported by published clinical literature concerning the use of existing Synthes Cortex Screws in pediatric populations (ages 2-12 years and 12-21 years), specifically where growth plates have fused or will not be crossed by screw fixation. |
| Design | Similar design. |
| Fundamental Product Technology | Incorporate the same fundamental product technology. |
| Materials | Composed of the same materials (stainless steel, commercially pure titanium, and/or titanium alloy). |
| Mechanical Properties (In Vitro Testing) | Calculations performed comparing: - Torsional strength - Insertion torque - Axial pullout - Bending strength (The document states these calculations "additionally support substantial equivalence" and that screw length has "no bearing on the cortical screws' performance or technical function," implying comparable performance to predicates) |
2. Sample size used for the test set and the data provenance:
- Not applicable (N/A) for an AI device. This submission concerns physical medical devices (screws). The "test set" in this context refers to the in-vitro mechanical testing conducted, not a dataset for an algorithm.
- Data Provenance: The document mentions "Published, clinical literature" to support pediatric use and "calculations comparing torsional strength, insertion torque, axial pullout, and bending strength" for mechanical properties. The specific details of these studies (e.g., number of screws tested, exact literature cited, countries of origin) are not provided in this summary. These would typically be detailed in a more comprehensive 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A for an AI device. Ground truth for an AI algorithm is typically established by human experts reviewing data. For this device, "ground truth" relates to the performance characteristics of the screws, established through engineering tests and scientific literature.
4. Adjudication method for the test set:
- N/A for an AI device. Adjudication methods like "2+1" or "3+1" are used to establish consensus among multiple human reviewers for AI algorithm ground truth. This is not relevant for a physical device submission.
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:
- No. This is not an AI device. Therefore, no MRMC comparative effectiveness study was conducted with human readers assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used:
- For the expanded pediatric indications: Published clinical literature on the use of similar Synthes Cortex Screws.
- For mechanical properties: Engineering calculations and in-vitro mechanical testing data (torsional strength, insertion torque, axial pullout, bending strength). Comparison against predicate device specifications or established industry standards would serve as the "ground truth" for demonstrating equivalence.
8. The sample size for the training set:
- N/A. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established:
- N/A. As there is no training set for an AI algorithm, no ground truth was established for it.
{0}------------------------------------------------
KII2583(112)
DEC - 5 2011
Attachment 2: Revised 510(k) Summary
| Sponsor: | Synthes (USA)Rebecca BlankAssociate Regulatory Affairs Specialist1301 Goshen ParkwayWest Chester, PA 19380(610) 719-1268FAX (484) 356-9682 |
|---|---|
| Date Prepared: | August 31, 2011 |
| Device Name: | Synthes Cortical Screws |
| Classification: | Class II, § 888.3040 - Smooth or Threaded Metallic Bone FixationFastenerProduct Code: HWC |
| PredicateDevice(s): | K030310 - Synthes Stainless Steel Modular Hand System |
| K010321 - Synthes Modular Foot System - 2.7mm Module | |
| K043185 - Synthes 3.5mm Cortex Screws | |
| K111230 - Synthes 3.5mm Low Profile Cortical Screws | |
| K000684- Small Fragment Dynamic Compression Locking (DCL)System | |
| K000682 - Synthes Large Fragment Dynamic CompressionLocking (DCL) System | |
| K100776 - Synthes 2.4mm/2.7mm Variable Angle LCPForefoot/Midfoot System | |
| K023879-Synthes Small Titanium Wrist Fusion Plate | |
| Device Description: | Screws have self-tapping features, stardrive, hexdrive, or cruciformhead recesses, and are manufactured from stainless steel,commercially pure titanium, and/or titanium alloy. Cortex screwsare offered both sterile and non sterile and are available in variouslengths. Screws may be used independently or with any Synthesplate which accepts 1.0mm, 1.3mm, 2.0mm, 2.4mm, 2.7mm,3.5mm, 4.0mm, and 4.5mm cortex screws. The subject screws,when used in pediatric applications, may be used independently orwith compatible Synthes plates which are also indicated forpediatric populations. |
| Indications forUse: | The Synthes 1.0mm, 1.3mm, 1.5mm, 2.0mm, and 2.4mm CortexScrews are intended for use in trauma procedures, reconstructiveprocedures, and general surgery of the hand, wrist, and other small |
{1}------------------------------------------------
bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 2.7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21years) when used with the Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).
The Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Information presented supports substantial equivalence of the Substantial Equivalence: Synthes Cortex Screws to the predicate devices. The proposed Synthes Cortex Screws have similar indications for use, are similar in design, incorporate the same fundamental product technology and are composed of the same materials. The intent of this 510(k) submission is to expand the indications for use statement to include the use of the device in pediatric patient populations. Published, clinical literature has been provided to support the use of 1.0mm, 1.3mm, 2.0mm, 2.4mm, 2.7mm, 3.5mm, 4.0mm, and 4.5mm Synthes Cortex Screws for the proposed indications and populations, and supports a substantially equivalent decision in comparison to predicate Synthes Cortex Screws.
To additionally support substantial equivalence, calculations comparing torsional strength, insertion torque, axial pullout, and bending strength were performed. Screw length was determined to have no bearing on the cortical screws' performance or technical function, and therefore does not raise any new questions of safety and efficacy.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 5 2011
Synthes (USA) Products LLC . % Ms. Rebecca Blank Associate Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K112583
Trade/Device Name: Cortical Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: August 31, 2011 Received: September 6, 2011
Dear Ms. Blank:
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
{3}------------------------------------------------
Page 2 - Ms. Rebecca Blank
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 11 8809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. ANN, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Preat 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 tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K 112583(111)
Attachment 1: Revised Indications for Use
510(k) Number (if known):
Device Name: Synthes (USA) Cortical Screws
Indications for Use:
The Synthes 1.0mm, 1.5mm, 2.0mm, and 2.4mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 2.7mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21years) when used with the Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).
The Synthes 3.5mm and 4.0mm Cortex Screws are intended for fixation of fractures. osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The Synthes 4.5mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
Prescription Use X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MX
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112183
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.