MODIFICATION TO HBS HEADLESS BONE SCREW

{0}------------------------------------------------ K10103D ## 510k Summary Date Prepared: May 12, 2010 # Company Information | Sponsor/Manufacturer: | BioPro , Inc. | |-----------------------|--------------------------------------------| | Address: | 17 Seventeenth St.<br>Port Huron, MI 48060 | | Owner/Operator: | Pat Pringle | | ERN: | 1833506 | | Contact: | David Mrak | | Title: | Director of Product Development | | Phone: | (810) 982-7777 | | Email: | mrakd@bioproimplants.com | | Contract sterilizer: | Tri-State Hospital Supply | | Address: | 301 Catrell<br>Howell, MI 48843 | | ERN: | 1824619 | | Contact: | Karen Kowalczyk | | Title: | QA Director | | Phone: | 517-545-5400 | JUN - 3 2010 # Representative/Consultant N/A # Device Information HBS (Headless Bone Screw) Proprietary Name: Smooth or threaded metallic bone fixation fastener Common Name: Classification Name: Screw Fixation Bone Orthopedic (OR) Classification Panel: Class II per 21 CFR §888.3390 Regulatory Class: Product Code: HWC K020791; 510k 991197 Predicate Device: # Performance and Voluntary Standards No Performance Standards applicable to this device have been adopted under Section 514 of the Act. ## Intended Use , lof \$\bar{s}\$ {1}------------------------------------------------ The intended use and indications of the modified device are the intended uses and indications for the unmodified device however use in the skull has been omitted. The device is being offered sterile as opposed to non-sterile and additional lengths have been added. ## Sterilization Information | Method: | Ethylene oxide (EtO), fixed chamber | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterility Assurance Level: | 10-6 | | Validation Method: | AAMI Overkill Method | | Sterilization Site: | Tri-State Hospital Supply Howell, MI<br>ERN: 1824619 | | EO and ECH residuals: | The EtO residuals testing protocol requires residuals as per<br>ANSI/AAMI/ISO 10933-7 Biological evaluation of medical devices<br>- Part 7: Ethylene oxide sterilization residuals, paragraph 4.3.1<br>Permanent Contact Devices; as per this standard, the average<br>daily dose of EO to the patient shall not exceed 0.1 mg/day, and<br>the maximum EO dose shall not exceed 20 mg in the first 24<br>hours, 60 mg in the first 30 days, and 2.5 g in a lifetime. For ECH,<br>the average daily dose shall not exceed 2 mg/day, and the<br>maximum ECH dose shall not exceed 12 mg in the first 24 hours,<br>60 mg in the first 30 days, and 50 g in a lifetime. Provided the<br>measured EO residual is below 0.1 mg, the release rates cannot<br>exceed these limits; similarly, if the measured ECH residual is<br>below 2 mg, the release rates cannot exceed these limits. | | Packaging Information: | Peelable Tyvek® Lids, double Blister, in a cardboard box, and<br>tamper resistant outer labels. | ## Original unmodified predicate device: The original unmodified device was known as the HBS. The device was submitted under 510k 020791. The device was submitted by Millennium Medical Technologies, Inc. and was distributed by them. BioPro has obtained the rights to the 510k and has been legally marketing the device since 2008. #### Description: The BioPro HBS screw is designed for hand, foot and small bone fragment repairs or fusions. Uses include osteotomy fixation, joint arthrodesis or post traumatic fragment repair. The BioPro HBS screw is made of titanium in compliance with ASTM F136-02a. Titanium is a biocompatible material that is readily available and commonly used in implanted medical devices. The screw is similar to other screws available on the market. The HBS screw is cannulated and comes in two diameters, 2.5mm and 3.0mm. Each screw is available in several lengths ranging from 6mm up to 40mm in length the original system was available up to 30mm lengths and the original screws {2}------------------------------------------------ were provided non sterile. The new versions of the screw will be provided sterile. The screws have a Torx driving head. ### Device Comparison: | Feature | Substantially Equivalent Device(s) | BioPro HBS Screw | |---------------|--------------------------------------------------------------------------------------------------|-------------------------------------------| | Material | Vilex 510k 991197<br>Titanium ASTM F136-02a<br>HBS 510k 020791 | Titanium ASTM F136-<br>02a | | Sizes | Vilex 2.0-6.5mm<br>Osteomed K010783 2.0-2.4mm<br>HBS (original) 2.5-3.0mm up to<br>30mm lengths | 2.5-3.0mm 6mm to<br>40mm lengths | | Design | Vilex: Cannulated with hexagonal<br>drive<br>Osteomed: Cannulated with<br>Cruciform Drive | Cannulated with Torx<br>drive | | Sterilization | Vilex: provided non-sterile<br>Osteomed: Provided non-sterile<br>HBS Original | Provided sterile via<br>ETO Sterilization | ## Summary of modifications: The original screws were provided non-sterile and were available in two diameters, 2.5mm and 3.0mm with lengths up to 30mm The modified screws in this submission will now be provided sterile and the lengths will increase to 40mm with no changes to the diameter of the screw. Performance testing: The implant is made of titanium to the ASTM standards that are recognized consensus standards of the FDA. There is an ASTM standard F-543 entitled: "Standard Specification and Test Methods for Metallic Medical Bone Screw" An engineering rational is included in this submission in regards to this specification. ## Device Information: #### Intended Use: This device: - 1. has been previously submitted to the FDA for identical or different intended uses. Under 510k 0207091 - 2. is not currently being reviewed for different intended uses by the same or a different branch within the ODE 2 f 5 {3}------------------------------------------------ - 3. Has not been previously cleared by the FDA for different intended uses. #### Indications: | HBS-Mini (2.5mm) | HBS Standard (3.0mm) | |-------------------------------------|---------------------------------| | Scaphoid fractures | Scaphoid fractures | | Lunate fractures | Carpal fractures and non-unions | | Capitate | Capitellum fractures | | Trapezial fractures | Metacarpal fractures | | Metacarpal and metatarsal fractures | Phalangeal fractures | | Phalangeal fractures | Distal radial fractures | | Radial head fractures | Radial head fractures | | Ulnar styloid fractures | Ulnar styloid fractures | | Osteo-chondral | Small joint fusions | | Small joint fusions | Humeral head fractures | | | Glenoid fractures | | | Intercarpal fusions | | | Interphalangeal fractures | | | Metatarsal osteotomies | | | Tarsal fusions | | | Malleolar fractures | | | Patellar fractures | | | Osteo-chondral fractures | ## Contraindications: - 1. Comminuted bone surface that would mitigate against screw placement. - 2. Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the staple. - 3. Foreign body sensitivity to metals specifically titanium. Where material sensitivity is suspected, appropriate tests should be made prior to implantation. #### Materials: Titanium (ASTM F136-02a) ### Packaging/Sterilization Information: The packaging will consist of a double blister system; both blisters will use a tyvek backing and a polyethylene tray. A "peel" type opening will allow reliable removal of the product inside the sterile field. This packaging will be certified and tested according to current medical packaging requirements. All components will be sterilized using the ethylene oxide gas sterilization method and validated per ANSI/AAMI ST 27-1988 prior to marketing the device. See section 14 for sterilization validation information. With an SAL of 10 . {4}------------------------------------------------ ## Labeling Draft labeling for this device is included. ### Verification Activities Engineering rational provided for testing of the screws. No changes were made to the diameters so there would be no changes to the torsional strength. A complete summary of the studies as they relate to the sterilization are included in Attachment "B". of the submission. Also included is the complete risk analysis for the sterilization and packaging in Attachment "A". Based on these studies we believe the subject device is safe and affective ## Conclusion: The primary change for this special 510k submission was the change for non-sterile screws to sterile screws. The design of the screw is unchanged from our predicate device with the exception of the length increase of 10mm. Not only are the original sizes substantially equivalent to our existing device, they are identical in design and have not changed. The additional lengths were added and the 510k 991197 was used as the predicate for those changes. Considering that the design has not changed and the parts are now sterile we believe that we have shown the device to be substantially equivalent to the predicate devices. p. 5 of 5 {5}------------------------------------------------ Image /page/5/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. 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 emblem that resembles an abstract caduceus or a symbol representing health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002 BioPro, Inc. % Mr. David Mrak Director of Product Development 2929 Lapeer Road Port Huron, Michigan 48060 JUN - 3 2010 Re: K101030 Trade/Device Name: HBS Headless Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 17, 2010 Received: May 17, 2010 Dear Mr. Mrak: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {6}------------------------------------------------ Page 2 - Mr. David Mrak forth in 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 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" (2.1.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 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, Rabara Buchmp Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # Indications for Use K1010 30 510(k) Number (if known): Device Name: BioPro HBS (Headless Bone Screw) Indications for Use: | HBS-Mini (2.5mm) | HBS Standard (3.0mm) | |-------------------------------------|---------------------------------| | Scaphoid fractures | Scaphoid fractures | | Lunate fractures | Carpal fractures and non-unions | | Capitate | Capitellum fractures | | Trapezial fractures | Metacarpal fractures | | Metacarpal and metatarsal fractures | Phalangeal fractures | | Phalangeal fractures | Distal radial fractures | | Radial head fractures | Radial head fractures | | Ulnar styloid fractures | Ulnar styloid fractures | | Osteo-chondral | Small joint fusions | | Small joint fusions | Humeral head fractures | | | Glenoid fractures | | | Intercarpal fusions | | | Interphalangeal fractures | | | Metatarsal osteotomies | | | Tarsal fusions | | | Malleolar fractures | | | Patellar fractures | | | Osteo-chondral fractures | Prescription Use__X (Per 21 CFR 801 Subpart D) 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) Onette for myn (Division Sign off) Division of Surgical, Orthopedic, and Restorative Devices Page 1 of 1 510(k) Number K/01030