← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K112583 # SYNTHES CORTICAL SCREWS (K112583) _Synthes (USA) Products, LLC · HWC · Dec 5, 2011 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K112583 ## Device Facts - **Applicant:** Synthes (USA) Products, LLC - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Dec 5, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## Intended 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, 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. ## Device Story Synthes Cortical Screws are metallic bone fixation fasteners used for fracture, osteotomy, and non-union fixation. Screws feature self-tapping designs with stardrive, hexdrive, or cruciform head recesses. Available in various lengths and diameters (1.0mm–4.5mm). Manufactured from stainless steel, commercially pure titanium, or titanium alloy. Used independently or with compatible Synthes plates. Operated by surgeons in clinical settings (OR). Output is mechanical fixation of bone fragments. Benefits include stabilization of fractures and support for bone healing. This submission expands indications to include pediatric populations (2-21 years) where growth plates are fused or avoided. ## Clinical Evidence No clinical trials performed. Substantial equivalence supported by published clinical literature regarding the use of the specified screw sizes for the proposed indications and populations, supplemented by bench testing (torsional strength, insertion torque, axial pullout, and bending strength). ## Technological Characteristics Materials: stainless steel, commercially pure titanium, titanium alloy. Design: self-tapping, various head recesses (stardrive, hexdrive, cruciform). Diameters: 1.0mm, 1.3mm, 1.5mm, 2.0mm, 2.4mm, 2.7mm, 3.5mm, 4.0mm, 4.5mm. Mechanical fixation principle. Sterile and non-sterile options. ## Regulatory 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. ## Predicate Devices - Synthes Stainless Steel Modular Hand System ([K030310](/device/K030310.md)) - Synthes Modular Foot System - 2.7mm Module ([K010321](/device/K010321.md)) - Synthes 3.5mm Cortex Screws ([K043185](/device/K043185.md)) - Synthes 3.5mm Low Profile Cortical Screws ([K111230](/device/K111230.md)) - Small Fragment Dynamic Compression Locking (DCL) System ([K000684](/device/K000684.md)) - Synthes Large Fragment Dynamic Compression (DCL) System ([K000682](/device/K000682.md)) - Synthes 2.4mm/2.7mm Variable Angle LCP Forefoot/Midfoot System ([K100776](/device/K100776.md)) - Synthes Small Titanium Wrist Fusion Plate ([K023879](/device/K023879.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K112583](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K112583) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com