(21 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML terms or functionalities.
Yes
The ORTHOLOC™ SPS is intended for treating fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus by providing stable primary fixation using implanted plates and screws. These actions are therapeutic as they aim to heal or correct a medical condition.
No
This device is an orthopedic implant (plates and screws) used for surgical fixation of humerus fractures, not for diagnosing medical conditions. Its intended use is to provide "anatomical reduction and stable primary fixation," which is a treatment, not a diagnostic, function.
No
The device description explicitly states it includes implanted plates and screws made of stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the treatment of fractures and other conditions of the proximal humerus. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a plating system with plates and screws for surgical implantation. This is a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a person's health.
IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (inside the body) for surgical fixation.
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 (comma separated list FDA assigned to the subject device)
HRS, HWC, KTW, KTT
Device Description
The ORTHOLOC™ SPS Shoulder Plating System is 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 screws manufactured from stainless steel per ASTM F2229 and non-locking screws manufactured from stainless steel per ASTM F138 or ASTM F2229. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical bench testing was performed as indicated by risk analysis:
- Screw Torsion, Driving Torque, and Axial Pullout to ASTM F543-17. The subject device passed all testing with the same acceptance criteria as the predicate device.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the date July 17, 2019. The text is written in a clear, sans-serif font. The date is presented in a standard month-day-year format. The text is black against a white background.
Tornier Inc. Renee Stoffel Principal Regulatory Affairs Specialist 10801 Nesbitt Ave South Bloomington, Minnesota 55437
Re: K191711
Trade/Device Name: ORTHOLOC™ 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, KTW, KTT Dated: June 24, 2019 Received: June 26, 2019
Dear Renee Stoffel:
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. 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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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)
| Research Use (Part 81 CFR 801.3 and Part |
|---|
| Over-The-Counter Use (81 CFR 801.3 and |
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 a large, sans-serif blue font. To the right of the word is a blue hexagon containing a stylized letter "T" inside of it. The letter "T" is also blue and is made up of geometric shapes.
Date Prepared: June 24, 2019
Administrative Information
| Name: | Tornier, Inc. |
|---|---|
| Address: | 10801 Nesbitt Avenue South |
| Bloomington, MN 55437 | |
| United States of America | |
| Contact Person: | Renee Stoffel |
| Title: | Principal Regulatory Affairs Specialist |
| Phone: | 952-683-7471 |
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: | 21 CFR 888.3030 |
| Product Codes: | HRS, HWC, KTT, KTW |
Predicate Device Information
| Predicate: | ORTHOLOC™ SPS Shoulder Plating System |
|---|---|
| 510(k) Number: | K181587 |
Device Description
The ORTHOLOC™ SPS Shoulder Plating System is 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 screws manufactured from stainless steel per ASTM F2229 and non-locking screws manufactured from stainless steel per ASTM F138 or ASTM F2229. The system is provided non-sterile and requires steam sterilization prior to use.
Indications for Use
The ORTHOLOC™ SPS is intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.
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Image /page/4/Picture/1 description: The image shows the word "TORNIER" in a 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" in the hexagon has a smaller hexagon inside of it.
Comparison of Technological Characteristics with the Predicate Device
The modifications to the predicate system include the addition of blunt-tipped locking screws and an alternative stainless-steel alloy (ASTM F2229) for cortical non-locking screws.
Non-clinical Performance Testing
To demonstrate substantial equivalence to the predicate device, the following non-clinical bench testing was performed as indicated by risk analysis:
- Screw Torsion, Driving Torque, and Axial Pullout to ASTM F543-17 ●
The subject device passed all testing with the same acceptance criteria as the predicate device.
Clinical Testing
No clinical studies were performed.
Conclusions
The subject device is identical to the predicate device with respect to intended use, principle of operation, and conditions for use. The ORTHOLOC™ SPS Shoulder Plating System does not raise new questions of safety or effectiveness. Differences in technological characteristics that pose potential risks, as identified by risk analysis, have been addressed with verification testing. The results of testing for the modified ORTHOLOC™ SPS Shoulder Plating System support substantial equivalence to the predicate ORTHOLOC™ SPS Shoulder Plating System (K181587).