(53 days)
No
The 510(k) summary describes a mechanical orthopedic implant (rods and plates) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for internal fixation of fractures, bony fusions, non-unions, and reconstructive procedures, which are medical treatments for conditions.
No
The device description indicates that the ROI Rods and Plates are used for the mechanical reduction and fixation of fractures, boney fusion, and non-unions, as well as for reconstructive procedures. These are therapeutic functions, not diagnostic ones.
No
The device description clearly states that the device is comprised of physical components (rods and plates) made from titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the internal fixation of fractures, boney fusion, and non-unions, as well as reconstructive procedures. These are all surgical procedures performed directly on the patient's body.
- Device Description: The device description details physical implants (rods and plates) made of titanium, designed to be surgically inserted to stabilize bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used to physically repair and stabilize bone within the body.
N/A
Intended Use / Indications for Use
The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
Product codes
HWC, HRS
Device Description
The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rods come in a variety of diameters and lengths. The plates are available in various widths, lengths and thicknesses. Both the rods and plates have fins to aid in resisting rotation or movement. The rods and plates are made from titanium alloy ((T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium. The bodies are plasma spray coated with commercially pure titanium
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The ROI Rods and Plates are similar in function, material and indications to the Osteomed Cannulated Screw System (K010783) and Acumed Acutrak screws (K930834/K944330).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Osteomed Cannulated Screw System (K010783), Acumed Acutrak screws (K930834/K944330)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUI I 1 2005
K051309 f
510(k) Summary ROI Fusion Rods & Plates
| Date | May 16, 2005 |
|---|---|
| Submitter | Reiley Orthopaedics, Inc. |
| PO Box 129, | |
| Ross, CA 80301 | |
| Contact person | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 | |
| Trade Name | ROI Fusion Rods & Plates |
| Common name | Bone screw |
| Bone plate | |
| Classification name | Smooth or threaded metallic bone fixation fastener |
| Class II per 21 CFR section 888.3040 | |
| Single/multiple component metallic bone fixation appliances and | |
| accessories | |
| Class II per 21 CFR section 888.3030 | |
| Product Code | HWC |
| HRS | |
| Equivalent Device | Osteomed Cannulated Screw System (K010783) |
| Acumed Acutrak screws (K930834/K944330 |
Device Description
The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rods come in a variety of diameters and lengths. The plates are available in various widths, lengths and thicknesses. Both the rods and plates have fins to aid in resisting rotation or movement. The rods and plates are made from titanium alloy ((T1-6A1-4V ELI, ASTM F136 or Ti 3Al2.5V, ASTM B348 Grade 9) or CP titanium. The bodies are plasma spray coated with commercially pure titanium
Intended Use
The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
Summary Nonclinical Tests
The ROI Rods and Plates are similar in function, material and indications to the Osteomed Cannulated Screw System (K010783) and Acumed Acutrak screws (K930834/K944330).
1
JUL 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Riley Orthopaedics Incorporated C/o Mr. J.D. Webb Orthomedix Group Incorporated 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K051309 Trade/Device Name: ROI Fusion Rods and Plates Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HWC Dated: May 16, 2005 Received: May 19, 2005
Dear Mr. Webb:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Mr. J.D. Webb
This letter will allow you to begin marketing your device as described in your Section 510(k) rmovices notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
iriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ROI Fusion Rods and Plates
Indications for Use:
The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and The use of the rees appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).
Prescription Use _ X_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign 23)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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