(112 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are limited to mechanical bench testing.
Yes
The device is a plating system for fractures and non-unions, which is a common therapeutic intervention.
No
This device is a plating system designed for anatomical reduction and stable primary fixation of the proximal humerus for fractures and non-unions, functioning as a therapeutic implant rather than a diagnostic tool.
No
The device description explicitly states it is a "plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws." This clearly indicates a hardware-based medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus." This describes a surgical implant used to fix bones, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a "plating system designed to provide anatomical reduction and stable primary fixation of the proximal humerus using implanted plates and screws." This further confirms it's a physical implant for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
K011815, SYNTHES LCP PROXIMAL HUMERUS PLATES, K000684, SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM, K011335, SYNTHS ONE-THIRD TUBULAR DCL PLATE, K041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG, K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES, K100146 and K102352, EVOLVE EPS ORTHOLOC, K111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R TRIAD (TM) BONE SCREWS
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
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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
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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)
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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:
Address: | Tornier, Inc.
10801 Nesbitt Avenue South
Bloomington, MN 55437
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 |
| (DCL) SYSTEM | |
| K011335, SYNTHS ONE-THIRD TUBULAR DCL PLATE | |
| K041860, SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG | |
| K082625, SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL | |
| HUMERUS PLATES | |
| K100146 and K102352, EVOLVE EPS ORTHOLOC | |
| K111432, EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R | |
| 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
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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.