(35 days)
Not Found
Not Found
No
The description focuses on the mechanical components (plates and screws) and their intended use in bone fusion, with no mention of AI or ML capabilities.
Yes
The device is intended to help increase the rate of bony union and maintain the position of the toe during fusion for various medical conditions like fractures, deformities, and pain, all of which fall under therapeutic purposes.
No
The device description clearly states that the Bone Fusion Plate System "consists of plates and screws" used to increase the rate of bony union and maintain position during fusion, indicating a therapeutic or prosthetic purpose rather than a diagnostic one.
No
The device description explicitly states that the system consists of plates and screws, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a person's health.
- Device Description: The Bone Fusion Plate System is described as consisting of plates and screws intended for surgical implantation to aid in bone fusion and maintain toe position. These are physical implants used within the body.
- Intended Use/Indications for Use: The intended use and indications clearly describe the device's purpose in treating musculoskeletal conditions of the foot through surgical intervention, not through the analysis of biological samples.
Therefore, the Bone Fusion Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.
Indications for Use:
- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallus valgus
- · Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint
Product codes
HRS
Device Description
The Bone Fusion Plate System consists of plates, and screws. The design features of the components included in the Bone Fusion Plate System are summarized below:
Bone Fusions Plate
- · Left and Right configurations
- · Available in 2 options
2.7mm Cruciform Screws - · Non-locking
- · Lengths available: 8, 10, 12, 14, 16, 18, 20, 22, 24mm
3.2mm Cruciform Screws - · Non-locking
- · Lengths available: 14, 16, 18, 20, 22, 24mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsal-phalangeal joint
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
HALLU® Plate System
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.
0
K04 2205 1/2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Bone Fusion Plate System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | August 12, 2004 |
| Contact Person: | Jeanine H. Redden |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | Bone Fusion Plate System |
| Common Name: | Bone Fusion Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone – Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HRS |
DEVICE INFORMATION
A. INTENDED USES/ INDICATIONS
The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.
Indications for Use:
- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallus valgus
- · Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint
B. DEVICE DESCRIPTION
The Bone Fusion Plate System consists of plates, and screws. The design features of the components included in the Bone Fusion Plate System are summarized below:
1
K642205 2/2
Bone Fusions Plate
- · Left and Right configurations
- · Available in 2 options
2.7mm Cruciform Screws
- · Non-locking
- · Lengths available: 8, 10, 12, 14, 16, 18, 20, 22, 24mm
3.2mm Cruciform Screws
- · Non-locking
- · Lengths available: 14, 16, 18, 20, 22, 24mm
SUBSTANTIAL EQUIVALENCE INFORMATION C.
The indication for use of the Bone Fusion Plate System is substantially equivalent to the predicate device HALLU® Plate System. The safety and effectiveness of the Bone Fusion Plate System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow together.
SEP 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K042205 Trade/Device Name: Bone Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: August 12, 2004 Received: August 16, 2004
Dear Ms. Redden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) fee device is substantially equivalent (for the indications ferenced above and nave cetermined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regard the Medical Device Amendments, or to commerce price to May 20, 1978, is secordance with the provisions of the Federal Food, Drug, de vices mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercere, mains of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elaboried (soo as courols. Existing major regulations affecting your device can may be subject to subli additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oban ements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actives that I Dr researchat at your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cacial statutes and regulations and limited to: registration and listing (21 comply with an the Fee break and 101); good manufacturing practice requirements as set forth in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Jeanine H. Redden
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manieting your and equivalence of your device to a legally premarket notheadon: The PDA miaing of castion 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 II you desire specific advice for your ac 11 (301) 594-4659. Also, please note the regulation entitled, Condor the Orition of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bone Fusion Plate
Indications For Use:
The Bone Fusion Plate System is intended to help increase the rate of bony union, and to maintain the position of the toe during fusion. Once the joint has fused, the plate is secondary in the transmission of gait forces.
Indications for Use:
- · Fractures, osteotomies or arthrodesis of the first metatarsal-phalangeal joint
- · Deformity due to hallus valgus
- Deformity due to arthritis in the first metatarsal-phalangeal joint
- Loss of motion- hallux rigidus
- · Pain associated with osteoarthritis or rheumatoid arthritis in the first metatarsalphalangeal joint
- · Revision procedures where other treatments or devices have failed; and
- · Chronic instability in the first metatarsal-phalangeal joint
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042265