ORTHOLOC SPS Shoulder Plating System

K181587 · Tornier, Inc. · HRS · Oct 5, 2018 · Orthopedic

Device Facts

Record IDK181587
Device NameORTHOLOC SPS Shoulder Plating System
ApplicantTornier, Inc.
Product CodeHRS · Orthopedic
Decision DateOct 5, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Device Story

ORTHOLOC™ SPS is a metallic bone fixation system for proximal humerus fractures. System comprises anatomical plates (Standard, Posterior, Greater Tuberosity) and locking/non-locking screws. Used by orthopedic surgeons in clinical/OR settings to achieve anatomical reduction and stable primary fixation. Device provides mechanical support to bone fragments during healing. Surgeon selects appropriate plate/screw configuration based on fracture pattern; implants are secured to bone to stabilize the site. Benefits include restoration of skeletal alignment and stability, particularly in compromised (osteopenic) bone.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including plate bending/fatigue (ASTM F382-17), screw torsion/driving torque/axial pullout (ASTM F543-17), engineering analysis, and cross-sectional comparisons.

Technological Characteristics

Plates: stainless steel (ASTM F138). Locking screws: stainless steel (ASTM F2229). Non-locking screws: stainless steel (ASTM F138). System is non-sterile; requires steam sterilization. Mechanical fixation via locking/non-locking screw-plate interface.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, including those with osteopenic bone.

Regulatory Classification

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters 'FDA' in a blue box, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. October 5, 2018 Tornier Inc. Renee Stoffel Senior Regulatory Affairs Specialist 10801 Nesbitt Avenue South Bloomington, Minnesota 55437 Re: K181587 Trade/Device Name: ORTHOLOCTM SPS Shoulder Plating 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, HWC Dated: August 30, 2018 Received: August 31, 2018 Dear Ms. Stoffel: We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Laurence D. Coyne -S For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181587 Device Name ORTHOLOC™ SPS Shoulder Plating System Indications for Use (Describe) The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" that is also blue. The letter "T" is made up of two smaller hexagons. Date Prepared: October 4, 2018 #### Administrative Information | Name:<br>Address: | Tornier, Inc.<br>10801 Nesbitt Avenue South<br>Bloomington, MN 55437<br>United States of America | |-------------------|--------------------------------------------------------------------------------------------------| | Contact Person: | Renee Stoffel | | Title: | Sr. Regulatory Affairs Specialist | | Phone: | 952-683-7471 | | Fax: | 952-426-7601 | #### Device Information | Name of Device: | ORTHOLOC™ SPS Shoulder Plating System | |----------------------|-----------------------------------------------------------------------------| | Common Name (s): | Humeral Plating System | | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories | | Regulatory Class: | II | | Regulation Number: | 888.3030 | | Product Code: | HRS, HWC | # Predicate Device Information | Primary Predicate: | K011815, SYNTHES LCP PROXIMAL HUMERUS PLATES | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Additional Predicates: | K000684, SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING<br>(DCL) SYSTEM<br>K011335, SYNTHS ONE-THIRD TUBULAR DCL PLATE<br>K041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG<br>K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL<br>HUMERUS PLATES<br>K100146 and K102352, EVOLVE EPS ORTHOLOC<br>K111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R<br>TRIAD (TM) BONE SCREWS | ## Device Description ORTHOLOC™ SPS is a plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws. The plates are available in three designs: Standard, Posterior, and Greater Tuberosity (GT) and are manufactured from stainless steel per ASTM F138. The system also includes locking cortical and cancellous screws manufactured from stainless steel per ASTM F2229 and non-locking cortical screws manufactured from stainless steel per ASTM F138. The system is provided non-sterile and requires steam sterilization prior to use. Tornier, Inc. ORTHOLOCTM SPS {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "TORNIER" in large, blue, serif font. To the right of the word is a blue hexagon containing a stylized letter "T" inside. The letter "T" is also blue and has a smaller, stylized "T" shape inside of it. The logo appears to be for a company or organization called "Tornier". #### Indications for Use The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. ## Comparison of Technological Characteristics with the Predicate Devices The ORTHOLOC™ SPS is substantially equivalent in intended use, materials, design, and sterilization method to the predicate devices. The design differences do not raise new issues of safety or effectiveness and are supported by performance testing. #### Non-clinical Performance Testing Non-clinical bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate devices. - o Plate Bending and Fatigue to ASTM F382-17 - Screw Torsion, Driving Torque, and Axial Pullout to ASTM F543-17 ● - Engineering Analysis of the Greater Tuberosity Plate ● - Cross Sectional Analysis comparing the subject and predicate plates #### Clinical Testing No clinical studies were performed. #### Conclusions The ORTHOLOC™ SPS does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the ORTHOLOC™ SPS system support substantial equivalence to the predicate devices.
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%