(218 days)
The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, bone peos, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are precontoured to match the anatomy of the distal radius. They accept 2.0mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws. The bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates.
This a 510(k) premarket notification for the DRPx Locking Distal Radius Plate System. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of an AI/ML device.
Therefore, this document does not contain the information requested regarding acceptance criteria for an AI/ML device and a study proving the device meets those criteria. The provided text describes the regulatory clearance of an orthopedic implant system and focuses on its mechanical properties and equivalence to predicate devices, not on AI/ML performance.
Specifically, the document refers to:
- Performance Testing: Single cycle bend testing and bending fatigue testing performed on the plates per ASTM F382.
- Conclusion: The device was found to have acceptable mechanical characteristics for its intended uses.
This type of testing is relevant for the mechanical integrity of an implant, not for the performance metrics typically associated with AI/ML systems (like sensitivity, specificity, AUC, etc.).
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May 6, 2021
Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502
Re: K202971
Trade/Device Name: DRPx Locking Distal Radius Plate 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, HTN Dated: April 8, 2021 Received: April 9, 2021
Dear Douglas Fulton:
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.
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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
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, M.P.H. Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202971
Device Name
DRPx Locking Distal Radius Plate System
Indications for Use (Describe)
The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Prepared 5/6/2021
Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502
Contact: Douglas Fulton Quality Assurance Manager Telephone: 775-636-8281 Fax: 775-636-8284 Email: doug@orthoimplantcompany.com
Device Identification: Trade Name: DRPx Locking Distal Radius Plate System Common Name: Plate, Fixation, Bone Classification Name: Plate, Fixation, Bone (21 CFR 888.3030)(Primary); Screw, Fixation, Bone (21 CFR 888.3040); and Washer, Bolt Nut (21 CFR 888.3030) Classification: Class II Panel: Orthopedic Product Code: HRS (Primary), HWC, and HTN
Indications for Use: The DRPx Locking Distal Radius Plate System is indicated for the fixation of intra-and extra-articular fractures and osteotomies of the distal radius.
Device Description:
The DRPx Locking Distal Radius Plate System consists of titanium plates for the distal radius, bone peos, bone screws and instruments to facilitate implantation. The Distal Radius plates come in a variety of sizes and are precontoured to match the anatomy of the distal radius. They accept 2.0mm locking screws, and 2.6mm and 3.5mm locking and non-locking bone screws. The bone screws range in length from 6mm to 30mm. The system also includes instruments used to implant the plates.
Comparison of Technological Characteristics (Substantial Equivalence):
Primary predicate device: Orthopaedic Implant Company K123832 OIC Distal Radius Plating System Additional predicate devices: Skeletal Dynamics K182492 Geminus Volar Distal Radius Plate System. Microware K171904 Tandry Locking Plate System
The DRPx Locking Distal Radius Plate System has the following similarities to those which previously received 510(k) concurrence:
· has the same indicated use,
- · uses the same operating principle,
- · incorporates a very similar design, and
- · incorporates the same materials
Performance Testing:
Single cycle bend testing and bending fatigue testing were performed on the OIC and Microware distal radius plates per ASTM F382, "Standard Specification and test Method for Metallic Bone Plates and screws/pegs of the DRPx Locking Distal Radius Plate System were evaluated using engineering analysis. The plates and plate/screw constructs were found to have acceptable mechanical characteristics for the intended uses.
Conclusion:
The DRPx Locking Distal Radius Plate System described in this substantially equivalent to the predicate devices.
§ 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.