(90 days)
No
The device description and intended use clearly describe a mechanical screw for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device, Synthes Cortex Screws, is intended for use in trauma and reconstructive procedures, and general surgery for fixation of fractures, osteotomies, and non-unions, which falls under therapeutic applications to treat medical conditions.
No
Explanation: The device, Synthes Cortex Screws, is intended for use in surgical procedures (trauma, reconstructive, general surgery) for bone fixation. It is a therapy device, not a diagnostic one.
No
The device description clearly states that the device is a physical screw made from stainless steel, commercially pure titanium, and/or titanium alloy. It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in surgical procedures for fixing bones and bone fragments. This is an in-vivo application (within the living body).
- Device Description: The description details the physical characteristics of screws used for surgical implantation.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Synthes 1.0mm, 1.3mm, 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 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 and 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand, wrist, other small bones and bone fragments, foot, ankle, clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, fibula
Indicated Patient Age Range
Adults, children (2-12 years), adolescents (12-21 years)
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)
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.
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.
K030310, K010321, K043185, K111230, K000684, K000682, K100776, K023879
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
§ 888.3040 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.
0
KII2583(112)
DEC - 5 2011
Attachment 2: Revised 510(k) Summary
| Sponsor: | Synthes (USA)
Rebecca Blank
Associate Regulatory Affairs Specialist
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-1268
FAX (484) 356-9682 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 31, 2011 |
| Device Name: | Synthes Cortical Screws |
| Classification: | Class II, § 888.3040 - Smooth or Threaded Metallic Bone Fixation
Fastener
Product Code: HWC |
| Predicate
Device(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 Compression
Locking (DCL) System |
| | K100776 - Synthes 2.4mm/2.7mm Variable Angle LCP
Forefoot/Midfoot System |
| | K023879-Synthes Small Titanium Wrist Fusion Plate |
| Device Description: | 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. |
| Indications for
Use: | The Synthes 1.0mm, 1.3mm, 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 |
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