(28 days)
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of bone plates and screws, with no mention of AI or ML.
No.
The device is described as a bone plate and screw system intended for fixation of fractures and non-unions, which provides structural support rather than a therapeutic function.
No
Explanation: The device is a bone plate and screw system intended for fixation of fractures and non-unions, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states it consists of implants (plates and screws) and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula". This describes a surgical implant used to stabilize bones within the body.
- Device Description: The description details "implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments". This further reinforces its use as a physical device for internal fixation.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests.
The OsteoCentric Bone Plate and Screw System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula
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)
Per the described risk analysis in Section 9, the mechanical performance of the OsteoCentric Bone Plate and Screw System was established per K152000, K150981, and K150188. The addition of the proposed subject components introduced no new worst case conditions to those that were already tested per ASTM F543 and ASTM F382 and cleared. No performance testing was performed for this submission because substantial equivalence was already established in the previously clearances and an engineering analysis was performed to confirm that the addition of the proposed subject components introduced no new worst case conditions to those that were previously cleared.
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.
K150981, K150188, K001945, K011335, K020872, K082807, K010321, K092609, K092889
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 22, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
OsteoCentric Trauma % Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918
Re: K190430
Trade/Device Name: OsteoCentric Bone Plate and Screw 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: February 21, 2019 Received: February 22, 2019
Dear Meredith May:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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.
Shumaya Ali -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) K190430
Device Name
OsteoCentric Bone Plate and Screw System
Indications for Use (Describe)
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures
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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| Submitter's Name: | OsteoCentric Trauma |
|---|---|
| Submitter's Address: | 5113 Southwest Pkwy, Ste. 150 |
| Austin, TX 78735 | |
| Submitter's Telephone: | 800-969-0639 |
| Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was Prepared: | 21-Feb-2019 |
| Trade or Proprietary Name: | OsteoCentric Bone Plate and Screw System |
| Common or Usual Name: | Plate, Fixation, Bone |
| Screw, Fixation, Bone | |
| Classification: | Class II per 21 CFR §888.3030 |
| Product Code: | HRS, HWC |
| Classification Panel: | Division of Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.
INDICATIONS FOR USE
The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures.
The indications for use for the OsteoCentric Bone Plate and Screw System are identical or similar to that of the predicate devices.
TECHNICAL CHARACTERISTICS
The OsteoCentric Bone Plate and Screw System is made from medical grade stainless steel that conforms to ASTM F138. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Principles of operation
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The differences between the subject and the primary predicate include:
- . The subject system is offered with both locking and non-locking plates and screws whereas the primary predicate system is only non-locking.
- . The diameter range for screws increased from 2.0mm – 4.5mm previously cleared to 2.0mm - 5.0mm.
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | |
|---|---|---|---|
| K152000 | SMV Bone Plate and Screw System | SMV Scientific | Primary |
| K150981 | SMV Scientific Bone Screws | SMV Scientific | Reference |
| K150188 | SMV Scientific 4.5mm Bone Screws | SMV Scientific | Reference |
| K001945 | Medial Distal Tibia Plates | Synthes (USA) | Reference |
| K011335 | One-Third Tubular DCL Plate | Synthes (USA) | Reference |
| K020872 | 3.5mm Broad LC-DCP Plates | Synthes (USA) | Reference |
| K082807 | 3.5 and 4.5mm Locking Compression Plate System | ||
| with Expanded Indications | Synthes (USA) | Reference | |
| K010321 | Modular Foot System - 2.7mm Module | Synthes (USA) | Reference |
| K092609 | 3.5mm and 4.5mm Curved Narrow and Broad | ||
| Locking Compression Plates (LCP), Straight | |||
| Compression, Straight Reconstruction Bone Plates | Synthes (USA) | Reference | |
| K092889 | Syntec Osteo-Plate and Screw Fixation | Syntec Scientific Corp. | Reference |
Predicate Devices
PERFORMANCE TESTING SUMMARY
Per the described risk analysis in Section 9, the mechanical performance of the OsteoCentric Bone Plate and Screw System was established per K152000, K150981, and K150188. The addition of the proposed subject components introduced no new worst case conditions to those that were already tested per ASTM F543 and ASTM F382 and cleared. No performance testing was performed for this submission because substantial equivalence was already established in the previously clearances and an engineering analysis was performed to confirm that the addition of the proposed subject components introduced no new worst case conditions to those that were previously cleared.
CONCLUSION
The subject modified is very similar to previously cleared SMV Scientific Bone Plate and Screw System. The subject OsteoCentric Bone Plate and Screw System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the OsteoCentric Bone Plate and Screw System is substantially equivalent to the predicate devices.