(75 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) for bone fixation. There is no mention of software, algorithms, or any technology related to AI or ML. The "variable angle locking technology" is a mechanical feature, not an AI/ML capability.
No
The device is an orthopedic implant (plate and screws) used for internal fixation of bone fractures, which is a structural support function, not a therapeutic mechanism.
No
Explanation: The device is described as a plate and screw system for the internal fixation of bone fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a plate and screw system made of titanium, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is for the "reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius." This is a surgical procedure performed in vivo (within the body) to treat a physical injury.
- Device Description: The description details a physical implant (plate and screws) made of titanium, designed to fix bones together. This is a surgical implant, not a diagnostic tool.
- 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 patient's health status, diagnose a condition, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to physically repair a bone fracture.
N/A
Intended Use / Indications for Use
The KMI Distal Volar Radius Plate is generally indicated for the reduction and fixation of fractures of the distal radius bone. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
Product codes
HRS
Device Description
Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.
Materials: Titanium; Ti-6A14V-ELI as per ASTM F136
Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal radial bone, distal radius
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)
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
APPENDIX I: SUMMARY OF SAFETY AND EFFECTIVENESS
For
KMI Distal Volar Radius Plate System
1. Submitter:
Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Carlsbad. CA 92009
Contact Person:
John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road Carlsbad, CA 92009 (448) 760 1706 FAX (448) 760 1739
Date Prepared: May 29, 2004
- KMI Distal Volar Radius Plate System 2. Trade Name: Distal Volar Radius Fracture Repair System Common Name: Single, multiple component Metallic Bone Fixation Appliances Classification Name: and Accessories, per 888.3030
- Predicate or legally marketed devices which are substantially equivalent 3.
-Hand Innovations Distal Volar Radius Fracture Repair System (K002775)
Description of Device 4.
Description device is intended for use in the reduction, stabilization, and internal Fixation of proximal radial bone fractures. The design incorporates the use of a plate and two sets of bone screw sets that are fixated perpendicular. The implant utilizes 'variable angle locking technology' (VALT) screw locking system which facilitates precise angular positioning of the bone screws relative to the distal volar radius plate.
Materials: Titanium; Ti-6A14V-ELI as per ASTM F136
Function: The system functions to fix proximal radial bone fractures together, thereby facilitating fixation.
5. Intended Use
The use of the KMI Distal Volar Radius Plate is generally indicated for the reduction and fixation of fractures of the distal radius bone. It is indicated for use in the fixation of fractures classified as acute or fresh, as well as cases of non-union where conservative treatment options have failed. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
- Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:
There are no significant differences between the KMI Distal Volar Radius Plate and other systems currently being marketed which would adversely affect the use of the product. The KMI Distal Volar Radius Plate employs the same basic mechanical features as the predicate, legally marketed device specified in section I in that the essential configuration consists of a plate and sets of bone screws intended for use in the reduction of fractures of the distal proximal radius bone.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a logo with a bird in the center. The bird is flying to the right and has three lines representing its wings. The bird is inside of a circle that has text around the outside of it.
Public Health Service
AUG 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John G. Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc 6005 Hidden Valley Road Carlsbad, California 92009
Re: K041461
Trade/Device Name: KMI Distal Volar Radius 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: May 29, 2004 Received: June 2, 2004
Dear Mr. Spampinato:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) premained is substantially equivalent (for the indications ferenced above and nave acterimined and marketed predicate devices marketed in interstate for use stated in the encrosale) to regary regary the Medical Device Amendments, or to continered price to May 20, 1978, the exactions of the Federal Food, Drug, devices mat nave been recuire approval of a premarket approval application (PMA). alle Cosmetic Act (110) that to her request to the general controls provisions of the Act. The r ou may, merelore, mance of the Act include requirements for annual registration, listing of general controls provisions proctice, 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 elassified (vor a controls. Existing major regulations affecting your device can may be subject to suen additions. Title 21, Parts 800 to 898. In addition, FDA may be found in the OUD acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i least be advised that I Drivination that your device complies with other requirements of the Act that I Dri has made a astad regulations administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 comply with an the 11ct 621 CFR Part 801); good manufacturing practice requirements as set CT N Fart 607); adomig (DT CFR Part 820); and if applicable, the electronic forth in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. John G. Spampinato
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDF miding of cation 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 If you desire specific acvice for Jour ac (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Comphaliso at (537) 777 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,
Sincerely yours,
Mark A. Mikkelsen
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
3
Indications for Use
510(k) Number (if known):_K041461
Device Name: KMI Distal Volar Radius Plate
Indications For Use:
The KMI Distal Volar Radius Plate is generally indicated for the reduction, stabilization and internal fixation of proximal radius bone fractures and osteotomies involving the distal radius.
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)
Mak
Davision Sign-Off)
vision of General, Restorative,
Wological Devices
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Stock Number K04146/