← Product Code [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW) · K140875 # OPTOSSOL COMPRESSION DEVICE SYSTEM (K140875) _Genossis, LLC · JDW · May 30, 2014 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K140875 ## Device Facts - **Applicant:** Genossis, LLC - **Product Code:** [JDW](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW.md) - **Decision Date:** May 30, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use. ## Device Story OptOssol™ Compression Device System consists of metallic screws and wires designed to compact juxtaposed bone fragments; provides compression to enhance bone healing and fusion via immobilization of fragments; may be used with or without bone graft. Wires inserted using standard OR wire drivers; compression applied via provided driver. Partially threaded wires available with sleeve in various diameters/lengths to accommodate patient anatomy. Used in OR by surgeons (hand, orthopedic, podiatric). Output is physical stabilization of bone fragments; aids clinical decision-making by providing mechanical fixation for healing. Benefits patient by promoting bone fusion and fracture stability. ## Clinical Evidence Bench testing only. Mechanical testing performed per ASTM F543:2013 Standard Specification and Test Methods for Metallic Medical Bone Screws. ## Technological Characteristics Implants: 316 LVM Stainless Steel (ASTM F138). Instruments: 17-4PH Stainless Steel and Custom 465® Stainless Steel (ASTM F899). Mechanical fixation via compression screws/wires. Non-powered, manual surgical instrumentation. ## 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 - [K130298](/device/K130298.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}------------------------------------------------ ### MAY 3 0 2014 K140875 page 1 of 2 ## 510(k) SUMMARY ) ### GenOssis, LLC ## OptOssol™ Compression Device Systeṃ | Sponsor: | Manufacturer | GenOssis LLC
426 Pennsylvania Avenue, Suite 120
Fort Washington, PA 19034 | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | | Official Contact
Phone:
Fax: | Barry E. Sands
978-358-7307
978-358-7384 | | | Date prepared: | April 1, 2014 | | Device Name: | OptOssol™ Compression Device System | | | Classification
Name: | Smooth or Threaded Metallic Bone Fixation Fastener
Single/multiple Component Metallic Bone Fixation Appliances and
Accessories | | | Classification
Number: | 21 CFR Sec. 888.3030 and 21 CFR 888.3040
Class 2
Product Code: HTN, JDW and HWC | | | Description: | The GenOssis OptOssol™ Compression Device System implants consists of screws
designed to compact juxtaposed bone fragments in compression to enhance bone
healing and fusion through the immobilization of the fragments with or without the
use of bone graft. The wires are inserted using standard wire drivers present in the
operating room and compression is conducted using the provided driver.
The partially threaded Wires are available with a Sleeve, and in various diameters
and lengths to accommodate patient anatomy. | | | Intended Use: | The OptOssol™ Compression Device System is indicated for use in the internal
fixation of fractures, fusions and revisions, The system is intended for but not
limited to hand surgery, orthopedic surgery and podiatric surgery - but is not
intended for Spinal Use. | | | Material: | The OptOssol™Compression Device System is composed of 316 LVM ASTM F138.
The material composition has been established as a biocompatible material for
orthopedic permanent implants | | April 2, 2014 {1}------------------------------------------------ | | The instruments associated with the OptOssol™ Compression Device System are
composed of 17-4PH Stainless Steel and Custom 465® Stainless Steel (ASTM F899).
Both of these tissue-contacting materials have an established biocompatible profile
for surgical instruments in orthopedics. | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison to
Predicate
Devices | OptOssol™ Compression Device System has the same intended use as the predicate
device contained in K130298. The technological characteristics of material
composition and dimensional specifications fall within the range of the predicate
devices identified. Therefore, the OptOssol™ Compression Device System is
equivalent to the predicate devices identified. | | Performance
Data: | Mechanical tesing was performed per ASTM F543:2013 Standard Specification and
Test Methods for Metallic Medical Bone Screws. | | Performance
and SE
Determination: | Based upon the results of the performance testing the OptOssol™ Compression
Device System was determined to be substantially equivalent to the predicate
devices. | : . . . . . . . . . . . . . 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 : GenOssis, Inc. OptOssol™ Compression Device System : . April 2, 2014 : . . {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 30, 2014 GenOssis. LLC % Mr. Barry E. Sands RQMIS, Incorporated 29 Water Street. Suite 305 Newburyport, Massachusetts 01950 Re: K140875 . Trade/Device Name: GenOssis OptOssol™ Compression Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW, HTN, HWC Dated: April 2. 2014 Received: April 4, 2014 Dear Mr. Sands: 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 (sec above) into cither 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {3}------------------------------------------------ #### Page 2 – Mr. Barry E. Sands forth in the quality systems (QS) regulation (R1 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/ReportalProblem/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. Sincercly vours. ## Ronald P. Jean -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Indications for Use Statement · K140875 510(k) Number (if known):_ Device Name: GenOssis OptOssol™ Compression Device System · Indications for Use: The OptOssol™ Compression Device System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use. OR Prescription Use _ X (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) Page _1_ of _1_ # Elizabeth lägrank -S Division of Orthopedic Devices GenOssis, Inc. OptOssol™ Compression Device System April 2, 2014 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K140875](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDW/K140875) **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