← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K122293 # PIONEER STERNAL CABLE PLATE SYSTEM (K122293) _Pioneer Surgical Technology, Inc. · HRS · Oct 12, 2012 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K122293 ## Device Facts - **Applicant:** Pioneer Surgical Technology, Inc. - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Oct 12, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Pioneer Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. ## Device Story Pioneer Sternal Cable Plate System provides mechanical stabilization for anterior chest wall fractures and sternal reconstruction. System comprises titanium plates, integrated cables, crimps, and self-drilling screws (2.7mm/3.0mm diameter, 8-20mm length). Used by surgeons in clinical/OR settings to secure sternal segments post-sternotomy. Device functions as internal fixation hardware; provides structural support to bone segments to facilitate healing. No electronic or software components. ## Clinical Evidence Bench testing only. Evidence includes screw-plate interface tests, static and dynamic tensile tests, and dimensional comparisons to predicate devices. ## Technological Characteristics Materials: ASTM F67 Grade IV commercially pure titanium and ASTM F136 titanium alloy. Components: Plates, integrated cables, crimps, and self-drilling screws (2.7mm/3.0mm diameter). Mechanical fixation principle. No energy source or software. ## Regulatory 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. ## Predicate Devices - Ethicon Stainless Steel Suture Wire ([K946173](/device/K946173.md)) - Pioneer Songer Cable System ([K935481](/device/K935481.md)) - Lorenz Sternal Closure System with Modular Screw (Biomet SternaLock) ([K011076](/device/K011076.md)) - Biomet SternaLock Blu Microfixation Sternal Closure System ([K110574](/device/K110574.md)) - Synthes Modular Sternal Cable / Sternal Reconstruction System ([K031508](/device/K031508.md)/[K033816](/device/K033816.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}------------------------------------------------ P. 1/1 K122293 # 5.0 510(k) Summary | Sponsor: | Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette, MI 49855
(906) 225-5861 ·
Contact: Sarah McIntyre
Prepared: July 30, 2012 | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Pioneer Sternal Cable Plate System | | Classification: | Class II; Panel Code: 87
§888.3010 Cerclage, Fixation, Metallic (JDQ)
§888.3030 Plate, Fixation, Bone, Non-Spinal, Metallic (HRS)
§888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic (HWC) | | Predicate Devices: | Ethicon Stainless Steel Suture Wire (K946173)
Pioneer Songer Cable System (K935481)
Lorenz Sternal Closure System with Modular Screw (Biomet SternaLock)
(K011076)
Biomet SternaLock Blu Microfixation Sternal Closure System (K110574)
Synthes Modular Sternal Cable / Sternal Reconstruction System (K031508/
K033816) | | Description: | The Pioneer Sternal Cable Plate System contains various configurations of
plates, some with integrated cables and crimps, and. 2.7mm and 3.0mm
diameter self-drilling screws (lengths 8-20mm) to allow for multiple sternal
repair and reconstruction options.
The Pioneer Sternal Cable Plate System implants are manufactured from
medical grade ASTM F67 Grade IV commercially pure titanium and ASTM
F136 Titanium alloy. | | Indications for Use: | The Pioneer Sternal Cable Plate System is intended for use in the
stabilization and fixation of fractures of the anterior chest wall including
Sternal fixation following Sternotomy and Sternal reconstructive surgical
procedures. | | Performance Data: | Screw-Plate Interface Tests, Static and Dynamic Tensile Tests, and
dimensional comparisons were provided to support that the Pioneer Sternal
Cable Plate System performs in a manner substantially equivalent to that of
predicate systems. No new issues of safety or effectiveness were raised. | | Performance and
SE Determination: | Equivalence for the Pioneer Sternal Cable Plate System is based on
similarities of intended use, performance, design, materials, and physical
characteristics when compared to predicate devices. Therefore, Pioneer
Surgical Technology believes that there is sufficient evidence to conclude
that the Pioneer Sternal Cable Plate System is substantially equivalent to
existing legally marketed devices. | OCT 1 2 2012 : : 上一篇: {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 OCT 12 2012 Pioneer Surgical Technology, Inc. % Ms. Sarah McIntyre Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855 Re: K122293 Trade/Device Name: Pioneer Sternal Cable Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: HRS, JDQ, HWC Dated: July 30, 2012 Received: July 31, 2012 Dear Ms. McIntyre: 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. {2}------------------------------------------------ #### Page 2 - Ms. McIntyre 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 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 yours. Radiological Health Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Enclosure {3}------------------------------------------------ ## 4.0 Indications for Use Statement K122292 510(k) Number (if known): Device Name: Pioneer Sternal Cable Plate System Indications: The Pioneer Sternal Cable Plate System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures. > ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use #### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) OR Ash (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices k 122297 510(k) Number _ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K122293](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K122293) **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