(225 days)
The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device.
The large plate set components are indicated for the use including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacsals, phalanges, calcaneus and those of the ankle.
In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws are indicated for use in bone reconstruction, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
The SurgTech Trauma System is a plate and screw fixation system. Plates are offered in "mini," "small" and "large" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" "small" and "large" sets and, in addition, in locking cortical, non-locking cortical, cancellous and headless versions. Screws can also be used for fixation without the plates.
The provided text describes a 510(k) premarket notification for the "SurgTech Trauma System," which consists of bone plates and screws. This document is a regulatory submission to the FDA demonstrating substantial equivalence to existing legally marketed devices.
Crucially, the provided text DOES NOT contain information about an AI/ML-based medical device study.
Instead, the "Performance Data" section explicitly states that the device's performance was evaluated through mechanical testing of the plates and screws according to ASTM standards (ASTM F382 for bending, and other standards for torsion, insertion/removal, and pullout for screws).
Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria or a study proving its performance, as this document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or therapeutic device.
To reiterate, the document details:
- Device: SurgTech Trauma System (bone plates and screws)
- Purpose of Submission: 510(k) premarket notification for substantial equivalence.
- Performance Evaluation Method: Mechanical testing (e.g., static and dynamic bending, torsion, insertion/removal, pullout) against ASTM standards.
It does not mention any AI/ML components, ground truth establishment by experts, MRMC studies, or any other elements relevant to AI/ML device performance evaluation.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
SurgTech Inc Karen E. Warden, Ph.D. President Backroads Consulting Inc. PO Box 566 Chesterland, Ohio 44026-0566
Re: K161894
Trade/Device Name: SurgTech Trauma System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: January 23, 2017 Received: January 25, 2017
Dear Dr. Warden:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K161894
Device Name SurgTech Trauma System
Indications for Use (Describe)
The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device.
The large plate set components are indicated for the use including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacsals, phalanges, calcaneus and those of the ankle.
In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws are indicated for use in bone reconstruction, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Date: | 14 February 2017 |
|---|---|
| Sponsor: | SurgTech Inc.24600 Center Ridge Road, Suite 195Westlake, OH 44145Phone (216) 421-2613 |
| Sponsor Contact: | Xuegong Yu, General Manager |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Trade Name: | SurgTech Trauma System |
| Common Name: | Bone plates & screws, Bone screws |
| Device Classification | Class II |
| Classification Name: | Smooth or threaded metallic bone fixation fastener & Single/multiplecomponent metallic bone fixation accessories |
| Regulation: | 888.3040, 888.3030 |
| Device Product Code: | HWC, HRS |
| Device Description: | The SurgTech Trauma System is a plate and screw fixation system. Platesare offered in "mini," "small" and "large" set sizes in a variety of shapesbased upon the anatomical fixation required. Screws are also offered in"mini" "small" and "large" sets and, in addition, in locking cortical, non-locking cortical, cancellous and headless versions. Screws can also beused for fixation without the plates. |
| Indications for Use: | The SurgTech Trauma System plates and screws are intended to be usedfor internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device.The large plate set components are indicated for the use in various longbones including the femur and tibia. The small plate set is indicated for usein various bones including the clavicle, scapula, humerus, radius,ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in varioussmall bones including the metacarpals, metatarsals, phalanges, calcaneusand those of the ankle.In addition, the SurgTech Trauma System cancellous, cannulated lag,headless compression and non-locking cortical screws are indicated for usein bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repairand fracture fixation, appropriate for the size of the device. |
| Materials: | The SurqTech Trauma System implants are manufactured from titaniumalloys (Ti6Al4V per ASTM F136 and Ti6Al7Nb per ASTM F1295) andstainless steel (ASTM F138). |
| Primary Predicate(plate & screw system): | GPC Bone Plates and Bone Screws (GPC Medical K092493) |
| Additional Predicates(plate & screw system): | The NCB Periprosthetic Femur Polyaxial Locking Plate System (ZimmerInc. K100111), I.T.S. Straight Plate (I.T.S. GmbH K060156), I.TS. VolarRadius Plate (I.T.S. GmbH K033756), I.T.S. Olecranon Plate (I.T.S. GmbHK052368), Synthes Variable Angle LCP Elbow System (Synthes, K120070),I.T.S. Distal Humeral Plates (I.T.S. GmbH K080184), I.T.S. Straight Plate(I.T.S. GmbH K060156), I.T.S. Claviculatplate (I.T.S. GmbH K050852),Synthes (USA) Clavicle Hook Plate (Synthes, K031677), Synthes (USA)LCP® Proximal Humerus Plates (Synthes K041860), the I.T.S. PelvicReconstruction System (I.T.S. GmbH K063166), I.T.S. Fibula Plate (I.T.S.GmbH K063672), DePuy ALPS (DePuy Orthopaedics K082300), AcumedHand Fracture System (Acumed LLC K141383), Synthes LockingCalcaneal Plates (Synthes K991407), I.T.S. Calcaneus Repair System(I.T.S. GmbH K051642), Synthes 2.4 mm / 2.7 mm Variable Angle (VA), -LCP Forefoot /Midfoot System (Synthes K100776) and Medartis APTUS®Foot System (Medartis K091479), Synthes Titanium Small ReconstructionPlate (Synthes K915818), Synthes Large Fragment Dynamic CompressionLocking (DCL) System (Synthes K000682), Synthes Small FragmentDynamic Compression Locking (DCL) (System K000684), 1.5mm MiniFragment LCP System (Synthes K090047). |
| Primary Predicate(standalone screws): | OsteoMed Headless Cannulated Screw System (OsteoMed LP K063298) |
| Additional Predicates(standalone screws): | Treu Bone fixation Screws and Pins (Treu Instrumente GmbH K083912),Synthes Cortical Screws (Synthes K112583), Synthes 3.0 mm HeadlessCompression Screws (Synthes K050636), Synthes 4.5 mm and 6.5 mmHeadless Compression Screws (Synthes K080943), Vilex Bone Screw(Vilex K014154), Synthes 7.0/7.3 mm Cannulated Screws (SynthesK962011), SBi Foot and Ankle Cannulated Screws (Small Bone InnovationsK092754) |
| Performance Data: | Mechanical testing of the worst case SurgTech Trauma System platesincluded static and dynamic bending performed according to ASTM F382.Mechanical testing of the worst case SurgTech Trauma System screwsincluded torsion, insertion/removal and pullout performed according to |
| TechnologicalCharacteristics: | The SurgTech Trauma System implants possess technologicalcharacteristics similar to one or more of the cited predicate devices. Theseinclude: Mechanical performance (as described above), Basic design (bone plate & screw system), Use of implant grade materials (titanium, titanium alloys & stainless steel), and Dimensional sizes (comparable to those offered by the predicates). Minor dimensional differences between the subject and predicate devices,such as longer or shorter device lengths, did not raise new questions ofsafety and effectiveness. Therefore the fundamental scientific technology ofthe SurgTech Trauma System is the same as previously cleared devices. |
| Conclusion: | The SurgTech Trauma System possesses the same intended use andsimilar indications for use compared to the cited predicates. The SurgTechTrauma System technological characteristics are similar to those of thecited predicate devices. Therefore SurgTech Trauma System issubstantially equivalent for its intended use. |
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§ 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.