← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K073556 # MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS (K073556) _Medxpert GmbH · HRS · Jun 24, 2008 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K073556 ## Device Facts - **Applicant:** Medxpert GmbH - **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md) - **Decision Date:** Jun 24, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities. MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum. ## Device Story MedXpert P.E.S. and STRATOS are metallic bone fixation systems for thoracic surgery. P.E.S. consists of bendable straight bars customized to patient anatomy, secured with stabilizers and BarLock pins. STRATOS consists of bars and rib clips connected via press-fit to ribs. Used by surgeons in clinical settings to stabilize chest wall structures, facilitate bone healing, and correct deformities. Systems provide mechanical support to chest wall, aiding in structural reconstruction and fixation of fractures or osteotomies. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Metallic bone fixation appliances. P.E.S. system: bendable bars, stabilizers, BarLock pins. STRATOS system: bars, press-fit rib clips. Class II device (21 CFR 888.3030). ## 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 - Lorenz Pectus Support Bar ([K972420](/device/K972420.md)) - Lorenz Pectus Support Bar Stabilizer ([K981789](/device/K981789.md)) - Lorenz Pectus Support Bar System ([K061384](/device/K061384.md)) - Acute Bone Screw ([K061206](/device/K061206.md)) - MacroPore OS Reconstruction System ([K024169](/device/K024169.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}------------------------------------------------ # MEDXPERT ## K073556 JUN 2 4 2008 ## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN ACCORDANCE WITH SMDA OF 1990 Date of Application: November 21, 2007 APPLICANT: MedXpert GmbH Poststr. 55 D-79423 Heitersheim Germany Phone: +49 (7634) 506886 Fax: +49 (7634) 506887 Email: info@medxpert.com ### 1. Device Name | Trade Name: | MedXpert P.E.S. (Pectus Excavatum System) | |-------------|-------------------------------------------| | | MedXpert STRATOS™ | Pectus Excavatum System Common Name: ### 2. Classification Our implant system can be classified according following device names and product codes: | Device: | MedXpert STRATOS™
MedXpert P.E.S. (Pectus Excavatum System) | |--------------------|----------------------------------------------------------------| | Medical Specialty: | Part 878, General & Plastic Surgery | | Product Code: | HRS | | Regulation Number: | 888.3030 | | Device Class: | 2 | {1}------------------------------------------------ P.E.S. & STRATOS™ 510(k) Application # MEDXPERT #### Substantial Equivalence 3. MedXpert's P.E.S & STRATOS™ implant systems are substantial equivalent to the Lorenz Pectus Support Bar (K972420), Lorenz Pectus Support Bar Stabilizer (K981789) and Lorenz Pectus Support Bar System (K061384) of Walter Lorenz Surgical, Inc., Acute Bone Screw (K061206) of Acute Innovations LLC, and MacroPore OS Reconstruction System (K024169) of MacroPore Biosurgery, Inc. #### Description of the Device 4. MedXpert's P.E.S. implant system is consisting out of straight bars which can be bended according to the individual anatomic needs of the patient and different stabilizer which can be attached to the bar and secured by the BarLock™ Pin. MedXpert's STRATOS™ implant system is consisting out of Bar and Rip Clips; Rip Clips are combined by press fit with the bar and with the rips. #### Intended Use 5. MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities. MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum. #### Conclusion 6. Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that MedXpert's P.E.S & STRATOS™ implant systems are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act. {2}------------------------------------------------ Image /page/2/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MedXpert GmbH % Medagent GmbH & Co. KG Mr. Franz Menean Griesweg 47 Muhlheim, Baden-Wurttemberg Germany 78570 JUN 2 4 2008 K073556 Trade/Device Name: MedXpert P.E.S. (Pectus Excavatum System), MedXpert STRATOS Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 30, 2008 Received: June 11, 2008 Dear Mr. Menean: Re: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as sct {3}------------------------------------------------ ## Page 2 - Mr. Franz Menean 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Milliman Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K073556(pg 1/1) ## Indications for Use 510(k) Number: K073556 Device Name: MedXpert P.E.S. (Pectus Excavatum System) Implant System MedXpert STRATOS™ Implant System Indications for Use: MedXpert's P.E.S. implant system is intended for use in surgical procedures to repair Pectus Excavatum and other sternal deformities. MedXpert's STRATOS™ implant system is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of chest wall and sternum. Prescription Use _ YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ NO (21 SFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Cenbare Buem Division of General, Restorative, and Neurological Devices **510(k) Number** K073556 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K073556](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K073556) **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. 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